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Journal of Clinical Oncology, Ahead of Print.

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Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

In patients with muscle-invasive bladder cancer, event-free survival at 24 months was 63.5% with perioperative durvalumab plus neoadjuvant enfortumab vedotin as compared with 45.1% with surgery alone.

Among patients with HER2-positive advanced breast cancer, the HER2-targeted bispecific antibody anbenitamab plus albumin-bound docetaxel led to 24-month progression-free survival of 58.5%, as compared with 34.4% with standard therapy.

In a prespecified interim analysis of a phase 3 trial involving patients with extensive-stage SCLC, the median overall survival was 21.1 months with tarlatamab–durvalumab maintenance therapy and 12.7 months with durvalumab alone.

Scientific progress in oncology has been substantially advanced through mechanistic discovery. Human epidermal growth factor receptor 2 (HER2) was first established as an oncogenic driver by Slamon et al. in 1987, a discovery that catalyzed the development of highly effective, life-prolonging targeted therapies.1 Substantial progress has since been...

Among patients with relapsed small-cell lung cancer after chemotherapy, treatment with tambotatug pelitecan led to longer survival than treatment with topotecan, with fewer adverse events of grade 3 or higher.

The discovery of H. pylori has advanced the prevention and treatment of gastritis, peptic ulcers, and gastric cancer. Progress has been made in the research of H. pylori infection. These advances are discussed in this review.

Kunihiro Hattori, Tomoyuki Igawa, and Takehisa Kitazawa, who developed a prophylactic therapy for hemophilia A, have received the 2026 Lasker–DeBakey Clinical Medical Research Award.

A 52-year-old man with metastatic small-cell lung cancer was evaluated in the ophthalmology clinic because of vision loss in the left eye. A blood cytomegalovirus DNA viral load was 348 IU per milliliter. A diagnosis was made.

In a phase 1 study, RXRG001, a circular RNA encoding aquaporin-1, was administered to six patients with radiation-induced xerostomia. Measures of salivary flow improved, and adverse events were of grade 1 or 2 and transient.

In a trial involving adults with Ph-positive acute lymphoblastic leukemia, 24-month event-free survival was 86% with the TKI–immunotherapy combination ponatinib–blinatumomab and 67% with imatinib plus chemotherapy.

In a phase 3, randomized trial of lonvo-z, an in vivo gene-editing therapy, patients with hereditary angioedema who received the drug had a significantly lower attack rate than those who received placebo.

A 39-year-old man, who was an Iraq War veteran with exposure to burn pits, was admitted to the hospital with hypertension, abdominal pain, and foot drop. Imaging showed a thoracic spinal mass. A diagnosis was made.

A 44-year-old man was admitted for the management of carcinoid syndrome, which had been diagnosed 4 years earlier. On examination, mottled, violaceous, blanchable flushing was seen across the face and torso.

Hereditary angioedema is a disorder characterized by unpredictable, transient episodes of swelling and pain of various body parts. It can be life-threatening if the airway is involved. Current therapies include several different products that are administered prophylactically or at the onset of symptoms, and the prophylactic products must be administered...

The 21st volume of the IARC Handbooks summarizes and evaluates evidence for the benefits and harms of lung cancer screening with low-dose CT or chest radiography and assesses tools and strategies to improve screening.

It would be rare for anyone who has undergone intensive, multicycle, multiagent chemotherapy followed by allogeneic hematopoietic stem-cell transplantation to agree with Nietzsche’s personal view that “Out of life’s school of war, what does not kill me, makes me stronger.” Even though our past approaches to treating patients with the...

In a trial of a blood-based multicancer early-detection test added to usual care, the incidence of stage III or IV cancer after three rounds of screening did not differ significantly from that with usual care alone.

This review summarizes advances in therapy, including approval or expanded use of targeted agents, improved outcomes with antibody–drug conjugates and immunotherapy, and growing reliance on molecular profiling.

A 19-year-old woman presented with fever and cervical lymphadenopathy. The white-cell count was 2900 per microliter (reference range, 4000 to 11,000), and the lactate dehydrogenase level was elevated. A diagnosis was made.

The diagnosis of cancer at earlier stages is generally associated with improved survival. Detecting circulating tumor–derived cell-free DNA (cfDNA) is an established method of monitoring the response to therapy for many cancer types, particularly hematopoietic and metastatic cancers — which leads to the question of whether screening for cfDNA in...

Microplastics are a growing global concern and have been linked to various health conditions. A study presented by Ilias Dimeas and colleagues at the 2026 European Respiratory Society conference found a higher burden of microplastics in the lungs of patients with lung cancer than in those without cancer. In the study, 70% of 100 people undergoing a bronchoscopy had detectable microplastics in at least one sample, and patients with lung cancer were more likely to have detectable microplastics in their samples than patients without lung cancer.

In oncology practice, there are trade-offs between quality of life and survival for many therapies. Similar trade-offs exist for drug reimbursement based on therapeutic effectiveness, affected population, and cost.

Cancer remains a leading cause of death and disability globally, with a disproportionate rising burden in Africa.1,2 Effective policy response has been consistently hampered by fragmented and incomplete cancer surveillance data.3 For a long time, there has been an assumption that a global uniform framework for understanding cancer risk factors exists and is applicable universally.4 This concept of harmonised global data is plausible in well structured and well resourced health systems in which research and care systems are integrated—systems that exist mostly in high-income regions.

Personalised medicine has been shown to improve patient care and holds promise to further benefit treatment results. The Lancet Oncology Commission on accelerating equitable cancer genomics and precision oncology in health care and research provides an overview of state-of-the-art treatments and the situation in low-income and middle-income countries (LMICs). From targeted treatment using companion diagnostics, identifying targets to guide treatment decisions, to broad ‘omics testing in cancer of unknown primary and metastasised tumours, the field is vast and inequalities exist within and between countries.

Amid the promise of cancer genomics and precision oncology lies complex and ethically weighty issues. Genomics and other ‘omics are undoubtedly transforming cancer care for thousands of patients annually, enabling better prognosis, access to treatments or trials, or informing relatives. Yet, these interventions overwhelmingly benefit people in high-income countries: they are failing to reach most patients with cancer who could benefit, and those who are reached could, for reasons including health system readiness or data representation and interpretation, receive no or marginal benefit to their care.

Precision oncology has substantially changed the therapeutic landscape from a “one size fits all” approach to that of individualised (or personalised) treatments.1 The promise of precision oncology extends across the entire cancer continuum from prevention, early diagnosis, subtyping of tumours, treatment selection, risk-adapted therapies, development of novel anticancer medicines, and post-treatment surveillance.2 The Lancet Oncology Commission on accelerating equitable cancer genomics and precision oncology in health care and research focuses on the current challenges and practical solutions to faciliate wider implementation.

The Lancet Oncology Commission on accelerating equitable cancer genomics and precision oncology presents a worrying picture.1 While the number of precision oncology drugs continues to increase,2,3 access to testing and matched therapies remains profoundly unequal, research is concentrated in high-income countries (HICs) and populations of European ancestry, and expanding testing capacity has not always translated into proportionate population-level benefit. The Commission's survey of national cancer control programmes (NCCPs), conducted in collaboration with the Union for International Cancer Control and WHO International Agency for Research on Cancer (IARC) across 34 countries, found partial integration of genomics into most NCCPs, including in HICs.

The Lancet Oncology Commission on accelerating equitable cancer genomics and precision oncology in health care and research1 examines the gap between the promise of precision oncology and its delivery across global health systems. Raffaella Casolino and colleagues argue that precision oncology has advanced with remarkable speed, yet its clinical impact and sustainability remain uneven, meaning that for much of the world, precision oncology remains just a promise. The authors argue that if the vision of precision oncology is to be realised, health systems need to generate, integrate, govern, and learn from data.

Cancer drugs are increasingly unaffordable for health systems. Global spending on cancer drugs will reach US$441 billion by 2029.1 This 75% increase over 5 years cannot be explained by population ageing or changing prevalence alone. Instead, the price of cancer drugs is driving accelerated spending growth.2 Rising prices place considerable pressure on health systems, particularly when increased spending is not matched by commensurate improvements in patient health. Unfortunately, many expensive cancer drugs have highly uncertain safety and efficacy evidence at the time of market authorisation.

The Lancet Oncology Commission on accelerating equitable access to cancer genomics and precision oncology provides an important framework defining indicators that health systems can and should measure.1 Operationalising these indicators, however, requires substantial data infrastructure. One indicator in the Commission's Precision Oncology Access Cascade defines the group of eligible patients who receive recommended genomic testing. The number of patients tested is relatively straightforward to obtain; however, the number meeting the guideline criteria is not because this information is usually recorded as unstructured narrative text rather than as a structured field.

For most of the history of cancer genomics, the map of our knowledge has had blank spaces on it. In the Pan-Cancer Analysis of Whole Genomes, for example, roughly three quarters of donors were of European descent; samples from Latin American donors made up only about 1% of the large public repositories and samples from patients of Middle Eastern descent were almost entirely absent.1

Publication of England's National Cancer Control Plan (NCCP) in February, 2026,1 marked a hard-won achievement, after years of advocacy from patients, clinicians, charities, parliamentarians, and The Lancet Oncology.2,3 The expectation was to address long-standing systemic issues in treatment delays and quality, workforce shortages, and inequalities; but hopes were quickly dashed.4 The plan had no real new money, no additional workforce capacity, no expansion of treatment infrastructure, no prioritisation, and no implementation strategy.

We read with great interest the Article by Theodore L DeWeese and colleagues detailing the results of the PrTK03 phase 3 trial, which evaluated the addition of aglatimagene besadenovec (CAN-2409) and valacyclovir to standard-of-care external beam radiation therapy (EBRT) for localised prostate cancer.1 We commend the investigators for executing this decade-spanning study. The biological premise—using an adenoviral vector to exert localised cytotoxicity of a systemically administered prodrug while stimulating a T-cell-mediated immune response—is scientifically sound.

We thank Thomas Büttner and colleagues for their interest in our Article on the PrTK03 trial.1 In our trial, disease-free survival was the prospectively specified, US Food and Drug Administration-agreed primary endpoint under a Special Protocol Assessment, analysed in the intention-to-treat population and defined to include local failure, including positive biopsy, regional failure, distant metastasis, or death.1 The US Food and Drug Administration did not agree to use biochemical failure as a disease-free survival event.

Leonardo Brunetti and colleagues’ post-hoc analysis of the PACIFIC trial in The Lancet Oncology addresses an important and clinically timely question: whether baseline exposure to proton pump inhibitors or antibiotics modifies the benefit of durvalumab after concurrent chemoradiotherapy in patients with unresectable stage III non-small-cell lung cancer.1 The observed association between proton pump inhibitor exposure and inferior progression-free and overall survival in the durvalumab group, but not in the placebo group, is thought provoking.

I read with great interest the Article by Leonardo Brunetti and colleagues,1 which reported that baseline exposure to proton pump inhibitors was associated with substantially inferior progression-free and overall survival among patients receiving durvalumab after concurrent chemoradiotherapy in the PACIFIC trial, but not among those receiving placebo. The use of a randomised, placebo-controlled dataset to separate prognostic from predictive associations is a genuine advance over observational literature.

Leonardo Brunetti and colleagues report an important post-hoc analysis of the PACIFIC trial,1 showing that baseline exposure to proton pump inhibitors, and to a lesser extent antibiotics, was associated with inferior survival outcomes following durvalumab, but not placebo, in patients with unresectable stage III non-small-cell lung cancer (NSCLC). The randomised placebo-controlled setting and differential analysis across the treatment group are major strengths. Nevertheless, proton pump inhibitor exposure itself was not randomised, and the clinical context in which proton pump inhibitors were prescribed could be crucial to interpretation.

Leonardo Brunetti and colleagues report an association between proton pump inhibitor exposure and shorter overall survival among patients receiving consolidation durvalumab, but not placebo, in the PACIFIC trial, and propose gut dysbiosis as a potential underlying mechanism.1 We seek clarification on one aspect of the analysis and propose an alternative explanation.

We thank our colleagues for their thoughtful comments on our post-hoc analysis of PACIFIC.1 Their correspondence raises two issues: the definition of survival events and whether proton pump inhibitor exposure is causal or reflects its prescribing context.

Tang C, Sherry AD, Hwang H, et al. Lancet Oncol 2026; 27: 181–90—In this Article, in the Baseline castration sensitivity row of table 2, the data for patients who are castration resistant and those who are castration sensitive were reversed. This correction has been made to the online version as of Sept 3, 2026.

Brunetti L, Santo V, Pinato DJ, et al. Differential impact of proton pump inhibitors and antibiotics on immunotherapy efficacy after chemoradiotherapy in locally advanced non-small-cell lung cancer: a post-hoc analysis of the PACIFIC trial. Lancet Oncol 2026; 27: 1043–56—The appendix of this Article has been corrected as of Sept 28, 2026.

Kudo M, Abou-Alfa GK, Ren Z, et al. Durvalumab and tremelimumab, with or without lenvatinib, combined with transarterial chemoembolisation in participants with embolisation-eligible hepatocellular carcinoma (EMERALD-3): a global, randomised, open-label, sponsor-blinded, phase 3 study. Lancet Oncol 2026; 27: 1077–93—In this Article, sentence eight of the Findings in the Summary should have read ‘post-embolisation syndrome’. In the Outcomes section of the Methods, the disease control rate at 20 weeks explanation has been corrected.

Le X, Passaro A, Zhao Y, et al. Ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small-cell lung cancer after disease progression on EGFR tyrosine kinase inhibitor therapy (HARMONi): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol 2026; 27: 1094–109—In this Article, the second and third sentences of the ninth paragraph of the Results section should have read “The most common immune-related treatment-related adverse events of any grade in the ivonescimab plus chemotherapy group were hypothyroidism (18 [8%]) and hyperthyroidism (nine [4%]), and in the placebo plus chemotherapy group were rash (seven [3%]), alanine aminotransferase increased (seven [3%]), aspartate aminotransferase increased (six [3%]), and amylase increased (six [3%]).

The US President Donald Trump has issued an executive order stressing “maximal parental choice” and cutting the number of childhood vaccines recommended by the federal government to 11 from 18.

Africa's most populous country Nigeria plans to procure and install 35 additional linear accelerators (LINACs), substantially expanding its radiotherapy capacity. Six Cancer Centres of Excellence are also being developed, with centres in Katsina, Enugu, and Benin completed and commissioned. However, the new machines translating into wider access depends on availability of specialist staffing, maintenance, financing, and where the additional capacity is located.

Late and missed diagnoses, delays in cancer care, and physical harm were partly caused by England's National Health Service (NHS) system for general practitioners (GPs) seeking specialist advice before patient referral to hospital, according to an investigation by the Health Services Safety Investigations Body (HSSIB).

While tobacco-leaf production across the world declined by 19% between 2012 and 2024, it increased by 9% in Africa, according to a WHO analysis published on Aug 31, 2026. Moreover, during this period, there was a more than two-times increase in cigarette imports to Africa—from US$833 million to $1·77 billion.

Interim results from the phase 3 ARTEMIS-008 trial, presented by Jie Wang (Chinese Academy of Medical Sciences, Beijing, China), suggest risvutatug rezetecan, a B7-H3-directed antibody–drug conjugate (ADC), could be the new standard of care in relapsed small-cell lung cancer (SCLC). Patients were randomly assigned (1:1) to receive risvutatug rezetecan (8·0 mg/kg; n=230) or topotecan (1·2 mg/m2 on days 1–5; n=231) every 3 weeks. At a median follow-up of 12·2 months, overall survival (the primary endpoint) was significantly improved with risvutatug rezetecan compared with topotecan (18·5 vs 10·3 months; HR 0·46 [95% CI 0·35–0·62).

The Kenyan Government has agreed a deal with Pfizer that could reduce the price of selected cancer medicines by seven times. Costs are expected to drop from as much as 1 million Kenyan Shillings (KSh; US$7725) to below KSh50 000 ($386) per treatment cycle for some drugs. The agreement covers nine cancers: breast, stomach, colorectal, lung, prostate, and oesophageal cancers, as well as leukaemia, lymphoma, and multiple myeloma.

On Sept 8, 2026, New York City authorities released more than 170 000 pages of documents showing that officials misled the public about toxic air quality levels after the Sept 11, 2001, attack that killed more than 2600 people at the World Trade Center (WTC). Health researchers say the documents contain little medical information that is new but confirm that carcinogens and toxins were present months after the attacks, exposing 400 000 people in lower Manhattan to smoke, dust, and combustion products.

Throughout the history of cancer research, hyperbole has never been in short supply—whether it be Richard Nixon's war, Joe Biden's moonshot, or Cancer Research UK's 2023 declaration of a golden era. Driving such rhetoric has been the need to act against an enduring societal concern—cancer, the so-called Big C, society's number one fear.

When American cultural anthropologist Ernest Becker was awarded the 1974 Pulitzer Prize for his book, The Denial of Death, he had died of colorectal cancer only 2 months earlier. More than half a century later, the book feels almost uncomfortably contemporary in the oncology clinic. Although the book does not address cancer care directly, it speaks to what cancer reveals: mortality, and the symbolic structures we build to make that knowledge bearable. For Becker, identities, professions, institutions, religions, families, reputations, and achievements are ways in which the fragile self seeks continuity beyond finitude.

Mention the name Chris Hoy and it's natural to picture the Olympic cyclist, who won six gold medals and one silver in Sydney, Athens, Beijing, and London between 2000 and 2012. Fans voted for him to be named as the BBC Sports Personality of the Year in 2008, and he was knighted by the late Queen Elizabeth in the 2009 New Year honours list. However, over the past 2 years, Hoy has become famous for a completely different reason. In October, 2024, he revealed that he had received a terminal diagnosis of stage-4 prostate cancer, which had spread to his bones.

“I had cancer a couple of years ago—I don’t like to talk about it,” grinned comedian Matt Forde during his show at the Edinburgh Festival Fringe, the world's largest arts festival, which took place in Edinburgh, UK, on Aug 7–31, 2026. With a sly grin at his audience, he added “I’m not going to use it to sell tickets for another sold out night in Edinburgh.” Forde, who is best known for his impressions of politicians, was diagnosed in July, 2023, with a chordoma, a very rare sarcoma at the base of his spine.

Pembrolizumab plus chemotherapy followed by maintenance with pembrolizumab–olaparib showed a statistically significant and clinically meaningful improvement in progression-free survival versus chemotherapy, suggesting that this regimen might have potential for patients with newly diagnosed BRCA non-mutated stage III–IV epithelial ovarian cancer.

Our findings highlight the importance of infection control to achieve cancer prevention. Scientifically proven, but often underused, approaches include HPV and HBV vaccination; testing and treatment of HIV, H pylori, HBV, and HCV; safe injection practices; access to condoms and pre-exposure prophylaxis to prevent HIV transmission; and screening of precancerous lesions for HPV-driven cervical and anal cancer. Our findings also inform the investment cases for research and development for new prevention tools, most notably for EBV.

Hypofractionated postmastectomy radiotherapy provided durable locoregional control with no increase in severe late adverse events compared with conventional fractionation, supporting its use as a more time-efficient option than conventional fractionated radiotherapy.

Weekly PRO symptom monitoring was associated with meaningful improvement in long-term overall survival among patients with stage I–IV lung cancer. Median overall survival was 5 months longer in the intervention group than in the control group. These findings underscore the value of implementing PRO symptom monitoring within routine care for patients with lung cancer.

OPTIMUM shows sustained progression-free survival and overall survival improvement with risk-stratified extended therapy, supporting implementation of molecular diagnostics and tailored treatment in patients with newly diagnosed high-risk multiple myeloma.

The STAMINA lifestyle intervention meets best practice guidelines, can be implemented in NHS trusts in England, and offers clinicians a clear basis for identification and prescription of a supervised exercise and dietary advice intervention to mitigate negative effects associated with ADT.

The CPI2 model, using 14 readily available clinical parameters, demonstrated improvement in discriminative accuracy compared with the IMDC model. This classification should be further validated in other trial and observational populations and be used to reanalyse heterogeneity of treatment effects of immune checkpoint inhibitor-based combination regimens in trials shaping the current and future treatment landscape.

Wildfire-related PM2·5 showed greater toxicity per unit exposure than non-wildfire PM2·5. As wildfire-related PM2·5 is the fastest-growing contributor to ambient air pollution, there is an urgent need for updated strategies to manage wildfires and mitigate their effects.

Cancer is a growing contributor to the disease burden in Africa, with rising cases, deaths, and DALYs disproportionately affecting children, adolescents, and young adults. The increase in age-standardised mortality and DALY rates stands in sharp contrast to the ambitions of the Sustainable Development Goals for 2030 and the African Union Agenda 2063. Addressing this burden will require coordinated national and international action, with health-system strengthening and context-specific cancer-control strategies spanning prevention, early diagnosis, and treatment.

Cancer genomics and precision oncology are increasingly central to cancer care, but many health systems struggle to implement them equitably, effectively, and sustainably. This Commission defines the current global precision oncology landscape and analyses the scientific, structural, and health-system challenges shaping its delivery and impact. Findings indicate that access to cancer genomics and precision oncology remains profoundly unequal across and within countries, leaving millions of patients without guideline-indicated interventions each year.

Cancer susceptibility testing is rapidly advancing beyond specialist genetics clinics into routine oncology and population-level genomics initiatives. This expansion positions germline pathogenic variants in cancer susceptibility genes and polygenic risk scores as crucial tools for precision prevention, surveillance, and early detection. However, implementation has outpaced the evidence needed to justify testing at scale, particularly in well populations. For a small number of first-wave genes—including BRCA1, BRCA2, MLH1, and MSH2—cancer risks are well established and downstream medical interventions are supported by substantial observational evidence, albeit with an absence of randomised trials.

The gut microbiome is increasingly recognised as a clinically modifiable determinant of efficacy and toxicity across systemic cancer therapies, with the most mature evidence in patients receiving immune checkpoint inhibitors (ICIs). The composition and function of intestinal microbes can influence treatment outcomes by affecting immune priming, antigen presentation, host–microbial co-metabolism, drug biotransformation, and epithelial barrier integrity. In melanoma, non-small-cell lung cancer, and renal cell carcinoma, higher microbial diversity, ecological stability, and enrichment of immunostimulatory pathways have been associated with improved ICI response and survival.

A 58-year-old female, lifelong non-smoker with history of Parkinson's disease, presented with a palpable right breast lump to the Odette Cancer Centre at Sunnybrook Health and Sciences Centre (Toronto, ON, Canada) in April, 2024, and was diagnosed with right-sided oestrogen receptor-positive, HER2-positive breast cancer (cT3N0). She received neoadjuvant dose dense doxorubicin–cyclophosphamide followed by paclitaxel, trastuzumab, and pertuzumab. Lumpectomy and sentinel lymph node biopsy was performed revealing a pathological complete response.

Postdiagnosis weight trajectory and metabolic health are important prognostic factors for nonmetastatic RCC. Weight stability and absence of diabetes were associated with more favorable outcomes. Incorporating repeated BMI measurements and diabetes status may improve risk stratification during RCC survivorship.

Outcomes were more favorable with the combination of chemotherapy and RT (pre‐ or postoperative) versus no RT for initially unresected NRSTS. Patients with large synovial sarcoma may benefit from contemporary trial designs incorporating more of a risk‐based directed neoadjuvant chemotherapy and RT approach. Higher R0 margin status rates were achieved in protocols with specified preoperative RT, which resulted in improved outcomes.

Over the past couple of decades, the number of treatment options for patients with acute myeloid leukaemia has accelerated; however, most patients still do not survive long-term, with 5-year overall survival around 30%. For younger and functionally fit patients, the predominant front-line therapy has remained unchanged for half a century: intensive induction chemotherapy that includes cytarabine and anthracyclines (the 7+3 regimen). For older patients or those not able to undergo intensive chemotherapy, a combination of hypomethylating agent and venetoclax is now the standard front-line therapy, spearheaded by the VIALE-A trial in 2020.

Nicolò Peccatori and colleagues provide evidence for inotuzumab ozogamicin in paediatric very-high-risk first-relapse B-cell acute lymphoblastic leukaemia.1 The data support a less toxic bridge to haematopoietic stem cell transplantation (HSCT), but the response denominators support a more specific clinical interpretation: inotuzumab ozogamicin is best viewed as cycle-1 molecular triage, not prolonged reinduction or a replacement for UK ALLR3 chemotherapy. Because ITCC-059 was a single-arm study and its statistical design was modified from 43 to 31 patients while increasing the alpha-error to 10%, comparative claims should be reframed as response-adapted sequencing.

We appreciate discussing the ITCC-059 results in response to Xiaogang Hao and colleagues.

Once a scientist's dream, gene therapy for sickle cell disease has now entered clinical practice. Autologous gene-based therapies offer a potential curative option for a disease that affects approximately 7·7 million people worldwide and remains associated with substantial morbidity, premature mortality, and entrenched health inequities. Regulatory approval, however, represents only the first step in a much longer translational pathway. Experience from other high-cost innovations suggests that without concurrent investment in implementation, workforce preparation, and financing, access could remain uneven or delayed.

Vernon Louw was not that interested in haematology at first. As an undergraduate he had found the teaching “very laboratory based” and he “struggled to connect it with the patients behind the results”. This sentiment changed when he began treating patients with haematological malignancies as a registrar in internal medicine. “I came to appreciate that haematology combines complex diagnostic reasoning, laboratory science, and long-term relationships with patients in a particularly compelling way”, he recalled.

Sexual health is a fundamental component of overall wellbeing, yet it remains one of the least addressed dimensions of care for people living with sickle cell disease. At the ASCAT 2025 meeting in London, UK, ERN-EuroBloodNet and RADeep registry convened a 3-day patient educational workshop dedicated to this topic. The sessions brought together 27 people living with sickle cell disease and a multidisciplinary team comprising one obstetrician, one internist, two haematologists, and two psychologists, creating an intergenerational and intercultural space, with 13 countries represented to exchange perspectives.

To our knowledge, this is first clinical study of a Bruton tyrosine kinase inhibitor, rilzabrutinib, in warm autoimmune haemolytic anaemia. Rilzabrutinib showed robust overall and durable haemoglobin response and favourable safety in patients with previously treated warm autoimmune haemolytic anaemia. Rilzabrutinib has the potential to treat the underlying pathophysiology of warm autoimmune haemolytic anaemia through multi-immune modulation, induce a robust and sustained haemoglobin response, and provides an opportunity to decrease or stop corticosteroid use.

Rilzabrutinib showed continued, stable, and sometimes improved platelet responses, including in patients who were initially non-responsive in the double-blind trial. Additionally, rilzabrutinib improved several disease aspects, including physical fatigue and bleeding, supporting its multi-immune modulation mechanism in immune thrombocytopenia, and had a favourable safety profile. The long-term extension period of LUNA3 will further characterise the long-term efficacy and safety of rilzabrutinib in patients with difficult-to-treat immune thrombocytopenia, and the ongoing LUNA4 trial (NCT07007962) will determine the efficacy of rilzabrutinib in earlier-line treatment and its potential to achieve sustained treatment-free response.

Felzartamab plus lenalidomide–dexamethasone significantly prolonged progression-free survival compared with lenalidomide–dexamethasone alone, supporting felzartamab plus lenalidomide–dexamethasone as a potential new treatment option for Chinese patients with relapsed or refractory multiple myeloma.

Topical ruxolitinib showed significant clinical activity and favourable harms profile in active cutaneous cGVHD. Ruxolitinib cream could represent a steroid-sparing, skin-directed alternative or second-line therapy, expanding treatment options for patients with cutaneous cGVHD.

Mantle cell lymphoma has multiple treatment options, yet the disease is difficult to cure. Relapses are common, treatments can cause severe side-effects, and current recommendations are still largely based on age rather than biology. Although suitability for intensive treatment was previously the decisive parameter, increasing knowledge on the biology of mantle cell lymphoma and less toxic targeted therapies has made non-risk adapted treatments outdated. TP53 mutations or deletions, blastoid histology, and a high Ki-67 proliferation index consistently identify patients at high risk of relapse.

TP53 myeloid neoplasms are being increasingly encountered in clinical practice and have been recognised in 2022, as a unique entity in the setting of functional loss of the two copies of the gene. The classification of myeloid neoplasm based on presence of biallelic (multi-hit) TP53 should precede morphological classification. The identification of biallelic (multi-hit) inactivation continues to evolve and is a matter of great debate balancing definitive biallelic identification via assays, pathology classifications, and clinical applicability.

Plasma cell leukaemia is an aggressive plasma cell malignancy characterised by the presence of a high percentage of circulating clonal plasma cells on conventional peripheral blood smear examination. We argue that plasma cell leukaemia must no longer be considered as a separate disease entity but as a type of high-risk multiple myeloma. With the adoption of more strict criteria for defining high-risk multiple myeloma and the relaxation of criteria in defining plasma cell leukaemia, the clinical implications of the terms have converged.

Hematopoietic cell transplantation (HCT) offers a potentially curative therapy for sickle cell disease (SCD), but posttransplant complications, including clonal hematopoiesis (CH), may limit its long-term benefits. In a Plenary Paper, Weeks and colleagues identify newly emergent, donor-derived, and persistent recipient CH in a minority of patients after HCT, with TP53 mutations particularly associated with subsequent transplant-related myeloid neoplasms. These findings provide new insight into clonal evolution after HCT and the risks associated with HCT for SCD.

Autoimmune neutropenia (AiN) in adults is a rare, often chronic disorder with variable severity and poorly understood mechanisms of neutrophil destruction. In this How I Treat article, Leaf and Sykes explore the pathophysiology, diagnosis, and treatment of the disease through 4 illustrative cases. They underscore the need for an individualized approach and advocate for further research to better define disease mechanisms and develop more effective treatments.

Antigen loss is a major mechanism of relapse after B-cell maturation antigen (BCMA)–directed chimeric antigen receptor (CAR) T-cell therapy for multiple myeloma, prompting various strategies to target multiple antigens. One is to administer 2 distinct products together. Mailankody and colleagues report the results of the Targeting Antigens with Novel Dual Effector cells for Multiple Myeloma (TANDEMM) phase 1 study, showing that concurrent administration of BCMA- and GPRC5D-directed CAR T cells is safe and can be effective in a heavily pretreated population. However, relapse in some patients through antigen loss and unequal CAR T-cell expansion indicates that dual targeting does not fully prevent resistance.

Chimeric antigen receptor (CAR) T-cell exhaustion limits the durability of responses in lymphoma, highlighting the need to preserve T-cell function during therapy. Kim et al attempted to achieve this by knocking down expression of 2 inhibitory receptors in a new CD19-directed CAR T-cell product. They report a 67% complete response rate in relapsed/refractory large B-cell lymphoma (LBCL) in a phase 1/2 trial of anbalcabtagene autoleucel, which uses gene silencing technology to reduce programmed death 1 (PD-1) and TIGIT expression. However, progression remains common, underscoring the need to determine whether targeting additional exhaustion pathways can improve long-term disease control.

Infant B-cell acute lymphoblastic leukemia (B-ALL) is driven by developmental programs that enable leukemic transformation of fetal hematopoietic cells. Ling and colleagues show that the fetal development–specific RNA-binding protein LIN28B is required for the initiation and maintenance of KMT2A::AFF1-positive infant B-ALL by promoting proliferation, B-cell differentiation, and cell survival. These findings identify LIN28B as a potential therapeutic target while highlighting its context- and lineage-dependent role in infant leukemia.

Casein kinase 2 (CK2) signaling contributes to acute myeloid leukemia (AML) stem cell maintenance, but the mechanisms linking this pathway to leukemic transformation remain undefined. Lei and colleagues show that CK2-dependent phosphorylation of DEK, an abundant nonhistone chromatin protein, promotes recruitment of the transcription factor GABPA to drive PBX3 expression, sustaining AML stemness, and demonstrate that pharmacological CK2 inhibition with CX-4945 synergizes with venetoclax to delay disease progression. These findings identify a CK2-DEK-GABPA-PBX3 pathway as a potential therapeutic vulnerability in AML.

Anemia of aging is common, but its underlying mechanisms often remain unexplained despite standard diagnostic evaluation. Xie and colleagues identified an Odoribacter splanchnicus–phenylacetic acid pathway that impairs erythroid differentiation through histone phenylacetylation through disruption of the GATA switch required for normal erythroid maturation. These findings link aging-associated gut dysbiosis to impaired erythropoiesis and suggest potential microbiome- or metabolite-directed therapeutic strategies.

Antiphospholipid syndrome (APS) is a thromboinflammatory disorder in which the mechanisms that drive severe thrombosis remain incompletely understood. Field and colleagues show that platelet factor 4 (PF4), a chemokine released from platelets, forms a large trimolecular complex with β₂ glycoprotein I (β₂GPI) and neutrophil extracellular traps that enhances anti-β₂GPI antibody recognition and promotes platelet and neutrophil activation and thrombosis. These findings expand the traditional β₂GPI-centered model of APS and identify PF4 as a potential therapeutic target.

Therapeutic radiation for superficial tumors may cause cutaneous fibrosis, a late side effect with limited treatment options. Here, we investigated the underlying mechanisms driving radiation-induced cutaneous fibrosis.

Uniform radiation dose escalation has not improved outcomes in locally advanced non–small cell lung cancer (NSCLC), and locoregional failure remains common despite multimodal therapy. We evaluated whether fluorodeoxyglucose positron emission tomography (FDG-PET)–guided dose escalation to metabolically active tumor subvolumes reduces locoregional failure compared with standard chemoradiation.

Low-dose radiotherapy (LDRT) for benign disease is entering the mainstream radiation oncology debate1. In this clinical setting, the term generally refers to regimens delivering 0.5–1.0 Gy per fraction to total target doses of approximately 3–6 Gy. At these dose levels, ionizing radiation has anti-inflammatory and antiproliferative effects1,2. Plantar fasciitis, Dupuytren disease, Ledderhose disease, heterotopic ossification, and painful degenerative skeletal disorders have long been treated in parts of Europe, particularly Germany3,4.

Cardiac toxicity is a well-recognized, but poorly understood complication of radiotherapy (RT). In non-oncological settings, there is an established relationship between resting heart rate and cardiovascular health.

Tumor hypoxia has been recognized as a barrier to effective radiotherapy. Preclinical work identified the FDA approved smooth muscle relaxant papaverine (PPV) as having an “off target” activity as a mitochondrial inhibitor that reduces hypoxia and radiosensitizes model tumors.

This Special Report analyzes current radiotherapy data standards, determines which radiotherapy data elements should propagate between them, and identifies the barriers to that propagation to improve interoperability and data utilization in clinical care and research.

Our purpose was to compare the safety and toxicity profiles of concurrent versus sequential administration of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) and postoperative radiotherapy (RT) in patients with Positive regional nodes, operable, hormone receptor-positive (HR+), HER2-negative breast cancer (HER2−).

Total mesorectal excision (TME) is standard for low rectal cancer (≤5cm from anal verge) but causes permanent stomas, functional impairments and surgical risks. Local excision (LE) suits early tumors (cTis-T1N0) but has higher recurrence in cT2+; watch-and-wait (WW) after neoadjuvant chemoradiotherapy risks residual disease. Total neoadjuvant therapy (TNT) improves outcomes, but prior LE trials had limitations.

Radiation injury to growth plates commonly leads to skeletal late complications including short stature, limb length-discrepancy, and scoliosis/kyphosis in pediatric oncology patients. We aimed to understand the acute responses of direct growth plate irradiation that result in skeletal late complications.

There is a paucity of high-level evidence for adjuvant radiation therapy (ART) in cutaneous squamous cell carcinoma (CSCC) creating practice variations. This study provides expert consensus recommendations on patient and tumor selection, timing, duration, dosage, and additional considerations for ART in node-negative CSCC.

Ultra-hypofractionated whole-breast radiotherapy has become an accepted option for early breast cancer, but evidence on the incorporation of a simultaneous integrated boost within a five-fraction schedule remains limited. The present study evaluated five-year late side effects after whole-breast irradiation with a simultaneous integrated boost delivered in five fractions in a prospective multicentre cohort.

Radiotherapy confers a later risk of secondary malignancies, including radiation-associated breast cancer. Distinctive molecular profiles emerge in tumors from pre-irradiated tumor beds, but effects on therapeutic options remain understudied.

Clinical proton dose prescription uses a fixed relative biological effectiveness (RBE) factor of 1.1 despite preclinical and clinical evidence that RBE varies with dose, radiation quality, and tissue radiosensitivity, particularly near the distal edge of treatments. We present a proton clinical dose-prescription system which: (1) is consistent with the clinical RBE of 1.1 for target dose definition, (2) uses full microdosimetric spectral distributions including primary and secondary ions, and (3) accounts for RBE variations in a framework analogous to that clinically used in carbon ion radiotherapy.

High-dose hyper-fractionated radiotherapy has been recently included in NCCN guidelines for limited-stage small cell lung cancer (LS-SCLC), which clinical outcomes are dependent on actually delivered biologically effective dose (BED). However, most tumor control probability (TCP) and normal tissue complication probability (NTCP) models rely on planed physical dose without considering inter-fractional deviations and BED of fractionization. This study aims to develop TCP and NTCP models for LS-SCLC incorporating CBCT-based inter-fractional anatomies and hyper-fractional radiobiological dose.

While accelerated hypofractionated radiotherapy has increasingly been adopted in the multidisciplinary management of locally-advanced non-small cell lung cancer (NSCLC) ineligible for concurrent chemotherapy, there is a paucity of randomized prospective evidence guiding utilization. Given the marked heterogeneity in the presentations of locally-advanced NSCLC, the American Radium Society (ARS) Thoracic Appropriate Use Criteria (AUC) Panel evaluated the appropriateness of accelerated hypofractionation in the context of multidisciplinary management.

To compare proton dynamic arc therapy (DynamicArc) with conventional intensity-modulated proton therapy (IMPT) for breast/chest wall irradiation across diverse clinical anatomies.

The final results from the German MINT study evaluating mogamulizumab in patients with mycosis fungoides and Sézary syndrome were recently presented at the European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) Annual Meeting 2026 in Berlin, Germany...

On October 16, 2026, the U.S. Food and Drug Administration (FDA) granted traditional approval to pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden–high...

A recent study by researchers from The Univetsity of Texas MD Anderson Cancer Center, ASCO, and collaborating institutions evaluated the national landscape of geographic access to active triple-negative breast cancer clinical trials. The findings—published by Amin et al in Breast Cancer Research...

Among medically underserved adults who smoked and were referred for lung cancer screening, the addition of financial incentives to usual care and free pharmacotherapy significantly increased rates of sustained tobacco abstinence compared with usual care alone or usual care plus free...

The addition of metastasis-directed ablation to first-line systemic therapy did not significantly improve progression-free or overall survival in patients with oligometastatic breast cancer, according to findings from the randomized phase II portion of the NRG-BR002 trial reported by Chmura et al...

I have had many idols in medicine. Many eventually let me down.

Remote expert review of oncology cases may help to address and improve gaps in evidence-based cancer care, while also providing measurable cost savings, according to findings presented in a poster at the 2026 ASCO Quality Care Symposium (Abstract 700). 

A shorter course of postmastectomy radiation therapy was noninferior to conventional radiation therapy in terms of breast reconstruction complications among women with breast cancer undergoing the procedure, according to findings from the randomized RT CHARM trial reported by Poppe et al in the

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Experts Call for Better Quality-of-Life Reporting in Adjuvant Cancer Trials

Clinical trials of adjuvant cancer therapy should do a better job of showing how treatment affects individual patients’ quality of life—particularly when the survival benefit is modest—according to recommendations from Common-Sense Oncology and the European Organisation for Research and Treatment...

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Starting Surveillance Colonoscopy After High-Risk Adenoma Removal: When Is the Right Time?

Surveillance colonoscopy at 5 years after removal of high-risk adenomas was noninferior to surveillance at 3 years in terms of colorectal cancer incidence during the first 5 years after adenoma removal, according to an interim analysis of the randomized EPoS II trial reported by Jover et al in The...

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AI Model Based on Facial Image Analysis Estimates Biological Age and Mortality Risk in Patients With Cancer

Analyzing facial images using a foundational artificial intelligence (AI) model may help researchers determine both biological aging and disease-related mortality risk, according to study findings published in The Lancet Digital Health. 

Tuesday, October 20, 2026 1:30 PM

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Community Oncology Practices Bring Advances in Cancer Testing and Treatment Closer to Patients

Community oncology practices are bringing personalized medicine into everyday cancer care, substantially expanding their use of advanced biomarker testing and novel therapies for patients with metastatic breast cancer and metastatic non–small cell lung cancer, according to new research from...

Tuesday, October 20, 2026 10:55 AM

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FDA Approves Atezolizumab in Combination With Chemotherapy for Stage III dMMR Colon Cancer

On October 8, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients aged 2 years and older with stage III mismatch repair–deficient (dMMR) colon cancer. The FDA...

Friday, October 9, 2026 10:38 AM

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FDA Approves Dostarlimab for MSI-H/dMMR Locally Advanced Rectal Cancer

On October 19, 2026, the U.S. Food and Drug Administration (FDA) granted an accelerated approval to the PD-1 inhibitor dostarlimab (Jemperli) for the treatment of adult patients with stage II/III locally advanced rectal cancer that is microsatellite instability–high (MSI-H) or mismatch repair...

Monday, October 19, 2026 3:00 PM

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National Academy of Medicine Elects 100 New Members for 2026

The National Academy of Medicine (NAM) has announced the election of 90 regular members and 10 international members during its annual meeting. Election to the Academy is considered one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated...

Monday, October 19, 2026 3:06 PM

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Phase III VERIFY Trial Demonstrates Benefits of Rusfertide in Polycythemia Vera

According to findings from the phase III VERIFY trial reported by Kuykendall et al in the Journal of Clinical Oncology, the addition of the hepcidin mimetic rusfertide to standard-of-care therapy significantly improved hematocrit control, reduced the need for phlebotomy, and improved...

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ASH Issues New Recommendations for the Management of Myelofibrosis

The American Society of Hematology (ASH) released new guidelines on the management of myelofibrosis which recommend expanded molecular testing, early transplant referral, appropriate use of JAK inhibitors, and aspirin therapy in select patients. The guidelines were published by Stein et al in Blood ...

Monday, October 19, 2026 10:28 AM

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Immunotherapy-Based Downstaging Linked to Improved Outcomes After Liver Transplantation in Hepatocellular Carcinoma

An immune checkpoint inhibitor–based multimodal downstaging strategy before liver transplantation was associated with improved posttransplant survival and a lower risk of recurrence among patients with hepatocellular carcinoma initially beyond the Milan criteria (single lesion not larger than 5 cm...

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Novel Androgen Receptor Degrader Demonstrates Antitumor Activity in Advanced Prostate Cancer

The novel androgen receptor degrader bavdegalutamide demonstrated a manageable safety profile and antitumor activity in patients with metastatic castration–resistant prostate cancer previously treated with androgen receptor pathway inhibitors, particularly those with tumors harboring specific...

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Verifying the Seen and Unseen by AI in Cancer Imaging

Artificial intelligence (AI) can be used in medical imaging and diagnostics to enhance physician capabilities, but also to identify features that humans are not able to see. In research settings, AI has already demonstrated that ability to identify biomarkers from routine medical images and guide...

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AI-Extracted Chart Data for Expanding Surgical Oncology Learnings

Large language models (LLMs) are capable of extracting structured data directly from electronic medical records, expanding data sets available for research, training, and developing artificial intelligence (AI) models.

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Even Highly Curable Childhood Leukemias Take a Substantial Toll on Families, Study Finds

New research published by Rodwin et al in JNCCN—Journal of the National Comprehensive Cancer Network has found that families of children receiving treatment for B-cell acute lymphoblastic leukemia (ALL) experience substantial and lasting challenges beginning early after diagnosis, according to a...

Friday, October 16, 2026 11:04 AM

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Two Studies Show Breast Cancer Survival and Mortality Gaps Are Widening Between Rural and Urban Areas

Survival and mortality disparities for women with breast cancer are widening between rural and urban areas over time, according to findings from two American Cancer Society studies presented at the 2026 ASCO Quality Care Symposium (Abstracts 208 and 253). 

Thursday, October 15, 2026 4:39 PM

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FDA Approves Expanded Indication for Nogapendekin Alfa Inbakicept in BCG-Unresponsive NMIBC

On October 14, 2026, the U.S. Food and Drug Administration (FDA) approved the IL-15 receptor agonist nogapendekin alfa inbakicept-pmln (Anktiva) in combination with bacillus Calmette-Guérin (BCG) for the treatment of adults with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC).

Wednesday, October 14, 2026 12:45 PM

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Iberdomide Triplet Improves MRD-Negative Complete Response in Relapsed/Refractory Multiple Myeloma

Iberdomide combined with daratumumab and dexamethasone nearly doubled the rate of minimal residual disease (MRD)-negative complete response compared with daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma. Lonial et al reported the primary MRD...

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Study Supports Sentinel Lymph Node Biopsy After Chemotherapy in Locally Advanced Breast Cancer

A prospective study found that sentinel lymph node biopsy may be an accurate method of axillary staging in selected patients with locally advanced breast cancer who achieve a clinical nodal response to neoadjuvant chemotherapy—potentially allowing some patients to avoid axillary lymph node...

Right ventricle (RV) dysfunction is associated with poorer outcomes in heart failure with preserved ejection fraction (HFpEF). Females are more likely to have HFpEF but males have worse prognosis and resting RV function. The contribution of dynamic RV-pulmonary artery (RV-PA) coupling between sex and its impact on peak exercise capacity (VO2) in HFpEF is not known.

A Phase I, single-center investigation demonstrated that 8 weeks of antimycobacterial therapy improved sarcoidosis forced vital capacity (FVC). Safety and efficacy assessments have not been performed in a multicenter cohort.

All aspects of medical education were affected by the Novel Coronavirus Infectious Disease-19 (COVID-19) pandemic. Several challenges were experienced by trainees and programs alike due to the economic repercussions of the pandemic, how social distancing affected the delivery of medical education, testing and interviewing, how the surge of patients affected redeployment of personnel, potential compromise in core training and the overall impact on the wellness and mental health of trainees and educators.

In this meta-analysis of observational studies, RV dysfunction was associated with higher short-term and long-term mortality in sepsis and septic shock.

Legionella is an uncommon cause of CAP, occurring primarily from late spring through early autumn. Testing is uncommon, even among patients with risk factors, and many positive patients failed to receive empiric coverage for LP.

The nS classification could be used to provide a more accurate prognosis in patients with resected NSCLC. The nS is worth taking into consideration when defining nodal category in the forthcoming ninth edition of the staging system.

NLP successfully identified a large cohort with CC. Most patients were identified through NLP alone, rather than diagnoses or medications. NLP improved detection of patients nearly seven-fold, addressing the gap in ability to identify and characterize CC disease burden. Nearly all cases appeared to be managed in primary care. Identifying these patients is important for characterizing treatment and unmet needs.

Pulmonary arterial hypertension (PAH) is a rare disease and much of our understanding stems from single-center studies, which are limited by sample size and generalizability. Administrative data offer an appealing opportunity to inform clinical, research, and quality improvement efforts for PAH. Yet, there is currently no standardized, validated method to distinguish PAH from other subgroups of pulmonary hypertension (PH) within this data source.

A transparent DL algorithm improves on traditional clinical criteria to predict the need for MV in hospitalized patients, including in those with COVID-19. Such an algorithm may help clinicians optimize timing of tracheal intubation, better allocate resources and staff, and improve patient care.

To assess airway and lung parenchymal damage non-invasively in cystic fibrosis (CF), chest MRI has been historically out of the scope of routine clinical imaging due to technical difficulties such as the low proton density and respiratory and cardiac motion. However, technological breakthroughs have recently emerged to dramatically improve lung MRI quality (including signal-to-noise ratio, resolution, speed, contrast). At the same time, novel treatments have changed the landscape of CF clinical care.

Bronchoscopic lung volume reduction with one-way endobronchial valves is a guideline treatment option for patients with advanced emphysema, supported by extensive scientific data. Patients limited by severe hyperinflation, with a suitable emphysema treatment target lobe and with absence of collateral ventilation are the responders to this treatment. Detailed patient selection, a professional treatment performance, and dedicated follow-up of the valve treatment, including management of complications, are key ingredients to success.

Chronic Obstructive Pulmonary Disease (COPD) may cause profound dyspnea, functional impairment, and reduced quality of life. Available pharmacologic therapy provides suboptimal symptom improvement in many patients. Bronchoscopic lung volume reduction (BLVR), achieved with endobronchial valve (EBV) placement, can effectively improve dyspnea and functional status in appropriately selected patients. Operationalizing a safe and effective BLVR program requires appropriate oversight which can be achieved by a BLVR Nurse Coordinator (NC).

Empathy-based, stigma-reducing communication may lead to improved assessments of tobacco use and smoking cessation for patients with smoking-related cancers. These findings support the dissemination and further testing of a new ECS model for training OCPs in best practices for assessment of smoking history and engagement of patients who currently smoke in tobacco treatment delivery.

In clinical practice, reslizumab may have been initiated in response to heavy symptom burden and CAEs. Reslizumab was associated with improved clinical and patient-reported outcomes and significant reductions in asthma-related HRU.

Quantitative emphysema measured on LDCT of the chest can be leveraged to improve lung cancer risk prediction and help diagnose COPD in individuals who currently or formerly smoked undergoing lung cancer screening.

Older adults (aged ≥65 years) comprise the majority of people diagnosed with cancer, yet they remain proportionally underrepresented in cancer research at every stage of the pathway. We call on funders, regulators, researchers and journals to make systematic inclusion of older adults the norm, across studies spanning from cancer prevention to end-of-life care.

The FDA recently approved daraxonrasib for patients with metastatic pancreatic adenocarcinoma who received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Critics call the second clause non-evidence based. However, this imprecision enables access: trials generally enrol only patients with good performance status, which does not reflect the realities for most patients with metastatic pancreatic adenocarcinoma who never reach second-line therapy because their clinical condition deteriorates first. Real-world evidence should resolve any remaining uncertainty.

Antibody–drug conjugates (ADCs) have transformed the management of various advanced-stage solid cancers. Nonetheless, and despite considerable development efforts, many of these agents lack reliable biomarkers of clinical benefit and/or are reliant on traditional methods of biomarker assessment, with biomarkers of resistance and/or toxicity largely overlooked. In this Review, the authors outline a modular ADC biomarker development strategy that considers the various components of these agents and discuss how biomarkers developed using this strategy might better inform patient selection, therapeutic sequencing, the development of rational combinations, dose optimization and regulatory strategy.

Adjuvant radiotherapy improves outcomes in patients with completely resected atypical meningioma

The iterative development of several highly effective treatments for HER2-positive breast cancer has transformed patient outcomes, but the now-crowded therapeutic landscape raises questions regarding the optimal approach for each patient. In this Review, the authors outline considerations for right-sizing therapy across the disease continuum, and discuss biomarkers that might facilitate this more individualized approach to treatment.

Exercise is widely endorsed as a supportive-care adjunct to mitigate adverse effects of cancer treatment, with data also suggesting potential therapeutic and preventive roles. In this Review, the authors discuss the current evidence from epidemiological studies and clinical trials for exercise as a factor modulating primary cancer risk and disease outcomes after diagnosis, and describe a translational framework for continued development of exercise therapy and a path towards precision exercise oncology.

Antibody–drug conjugates (ADCs) have reshaped the therapeutic landscape of many advanced-stage cancers. This clinical activity probably reflects mechanisms beyond targeted cytotoxicity, with emerging evidence suggesting an immune-mediated component. At the same time, regimens combining ADCs with immune checkpoint inhibitors (ICIs) are emerging as a highly effective treatment strategy in various malignancies. In this Review, the authors discuss the immunological mechanisms of action of ADCs, their clinical activity in combination with ICIs, as well as the potential of future agents and regimens to further improve outcomes.

Benefit with post-consolidation blinatumomab in newly diagnosed high-risk B-ALL

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The disclosure—which came ahead of a presentation of data from the Phase 1 Breakfree-2 study at the ACTRIMS-ECTRIMS meeting—follows Bristol Myers Squibb’s late summer revelation that it had paused certain trials of zolacabtagene autoleucel.

A combination of Tango Therapeutics’ vopimetostat and Revolution Medicines’ recently approved Rasonque led to a response rate of 82% in an ongoing Phase 1/2 trial—a drop from 92% that was reported in June in fewer patients.

After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aardvark plans to resume testing the candidate next year.

Rapport Therapeutics clocked its second Phase 2 win in 14 months for RAP-219—which the company is positioning as a potential pipeline-in-a-product—this time showing improvement in symptoms of bipolar mania.

Gilead’s emvistegrast delivered greater clinical response than placebo, setting up the asset for Phase 3 testing in ulcerative colitis as well as studies in other inflammatory diseases and bolstering the company’s push beyond its HIV portfolio.

AbbVie’s next-gen dual-targeting therapy elicited higher rates of remission than its IL-23 inhibitor Skyrizi in a Phase 2a trial of Crohn’s disease, leading analysts to wonder if the blockbuster can be outdone.

Novartis will continue to study Fabhalta in other indications, with late-stage studies in two rare diseases—atypical haemolytic uraemic syndrome and generalized myasthenia gravis—expected to read out later this year and next year, respectively.

Arrowhead Pharmaceuticals’ siRNA candidate achieved “compelling” tau reductions in an early study of healthy volunteers, with a magnitude of effect that seems to outperformother blood-brain barrier platforms, according to Stifel.

Revolution Medicines’ recently approved drug showed a 24% overall response rate and a high rate of side effects in patients whose cancer has a G12D mutation, reinforcing Mizuho’s view that a more specific agent such as Verastem Oncology’s VS-7375 “should come first for G12D patients.”

Syndax Pharmaceuticals will no longer test Niktimvo for idiopathic pulmonary fibrosis, but the company’s work to expand the drug’s label in chronic graft-versus-host disease, for which it was approved in 2024, will continue.

Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in a Phase 3 trial—becoming the first TROP2-directed ADC to do so in this setting, Merck told BioSpace.

When used alongside AstraZeneca’s Imfinzi, the bispecific T cell engager Imdelltra extended survival by eight months versus Imfinzi alone in Phase 3 study testing the combo in a first-line maintenance setting—a potentially “practice-changing” outcome, according to Truist Securities.

Extending both progression-free and overall survival, Genmab’s Rina-S “sets a high bar for future competition” in a market served by AbbVie, analysts said.

After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aardvark plans to resume testing the candidate next year.

AbbVie is eyeing regulatory filings in 2027 for the skin disease drug lutikizumab after clearing multiple endpoints in a late-stage trial, but the results have disappointed some analysts, raising questions about its commercial prospects.

Brepocitinib is on a roll. After winning approval for an autoimmune skin disease, Roivant Sciences subsidiary Priovant’s drug hit all primary and secondary endpoints in a pair of Phase 3 non-infectious uveitis trials, leading analysts to say the candidate “looked superior to Humira.”

Bracing for patent losses on its cornerstone product Darzalex, Genmab has bet its future on three cancer programs that will deliver pivotal readouts in quick succession.

Disc Medicine’s bitopertin—rejected by the FDA in February—significantly reduced levels of a key disease biomarker and significantly increased the time patients with erythropoietic protoporphyria were able to spend in the sun and artificial light.

In the wake of a successful IPO and strong stock growth throughout the year, Veradermics now has late-stage data to support a regulatory package for its hair loss pill.

While Oppenheimer doesn’t see the Phase 3 stumble of VQW-765 as highly detrimental to Vanda Pharmaceuticals, the analyst nevertheless believes the stakes are now higher for the company’s planned Q4 readout for Nereus in GLP-1-induced vomiting.

Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.

Merck stole the show at the European Society for Medical Oncology (ESMO) annual conference, with new data on its Moderna-partnered personalized cancer vaccine leaking prior to the presentation and antibody-drug conjugate sac-TMT making a splash in endometrial cancer; Bristol Myers Squibb revealed the death of a patient with multiple sclerosis in an early-stage trial of zola-cel; and pharma is on track to easily surpass last year’s deal count.

Drug developers increasingly have the option of seeking regulatory approval and commercializing a medicine themselves, rather than accepting an early exit offer. Doing so requires a worldwide strategy.

In a Phase 1 study, treatment with Incyte’s KRAS G12D inhibitor in combination with standard-of-care chemotherapy elicited an 89% confirmed objective response rate in patients with a type of pancreatic ductal adenocarcinoma, leading analysts to draw comparisons with Revolution Medicines’ zoldonrasib.

Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in a Phase 3 trial—becoming the first TROP2-directed ADC to do so in this setting, Merck told BioSpace.

After sitting through the full presentation on the Phase 3 INTerpath-001 trial at the ESMO Congress over the weekend, analysts are more keen on the personalized mRNA cancer vaccine data that last week spurred a stock selloff for both partners.

When used alongside AstraZeneca’s Imfinzi, the bispecific T cell engager Imdelltra extended survival by eight months versus Imfinzi alone in Phase 3 study testing the combo in a first-line maintenance setting—a potentially “practice-changing” outcome, according to Truist Securities.

Extending both progression-free and overall survival, Genmab’s Rina-S “sets a high bar for future competition” in a market served by AbbVie, analysts said.

CROs cite faster startup timelines, regulatory predictability and tax incentives as reasons for growing interest in Australia. State investments in manufacturing, translational research and advanced therapies aim to expand that advantage into a broader biotech ecosystem. The question remains whether Australia can support drug development at broader scale.

The disclosure—which came ahead of a presentation of data from the Phase 1 Breakfree-2 study at the ACTRIMS-ECTRIMS meeting—follows Bristol Myers Squibb’s late summer revelation that it had paused certain trials of zolacabtagene autoleucel.

On October 26, 2026, the Food and Drug Administration (FDA) approved talazoparib (Talzenna, Pfizer Inc.) in combination with enzalutamide for the treatment of adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with homologous recombination repair (HRR) gene mutations, as detected by an FDA-authorized test.

On October 16, 2026, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥13 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

On October 19, 2026, the Food and Drug Administration granted accelerated approval to dostarlimab (Jemperli, GSK) for adults with Stage II/III locally advanced rectal cancer (LARC) that is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-authorized test for solid tumors.

On October 14, 2026, the Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This revises the prior indication for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors to include patients with high-grade papillary-only tumors.

On October 8, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer. The FDA also approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients 12 years of age and older who weigh 40 kg or greater with Stage III dMMR colon cancer.

On October 7, 2026, the Food and Drug Administration approved tucatinib (Tukysa, Seagen Inc., a subsidiary of Pfizer) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment.

On October 2, 2026, the Food and Drug Administration approved pirtobrutinib (Jaypirca, Eli Lilly and Company) for adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion.

On September 24, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with lenvatinib (Lenvima, Eisai Inc.) for adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. 

On September 23, 2026, the Food and Drug Administration approved lirafugratinib (Lyrfigtu, Elevar Therapeutics, Inc.), a kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement.

On September 18, 2026, the Food and Drug Administration approved imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio), for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. Inluriyo and Verzenio are manufactured by Eli Lilly and Company.

On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.

On September 4, 2026, the Food and Drug Administration granted accelerated approval to camizestrant (Etcamah, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test. 

On August 26, 2026, the Food and Drug Administration approved daraxonrasib (RASONQUE, Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.

On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.

On July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).

On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).

On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy.

On July 9, 2026, the Food and Drug Administration approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications.

On June 30, 2026, the Food and Drug Administration approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq (Tregzi, Orca Bio) for use in matched donor hematopoietic stem cell transplantation (HSCT) with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGHVD)-free survival, in the treatment of adults with hematological malignancies.

On June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC). 

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