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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.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

A new European Union regulation introduces a centralized clinical assessment process for comparing the effectiveness and safety of new medicines with those of the standards of care in various countries.

In a phase 1 study of anito-cel, a CAR T-cell therapy, for relapsed or refractory myeloma, all 38 patients had a response. Severe cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome were rare.

Persons with Wiskott–Aldrich syndrome were treated with an autologous gene therapy consisting of hematopoietic stem and progenitor cells transduced ex vivo with a lentiviral vector encoding WAS complementary DNA.

The authors review the ways common genetic variants, polygenic risk scores, and pharmacogenomic genotyping may be useful in the prevention of common diseases and the treatment of common diseases after diagnosis.

The author describes the science behind a phase 1 study of anitocabtagene autoleucel, a CAR T cell that deploys a CAR with a novel synthetic antigen-binding domain, in patients with multiple myeloma.

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.

Gene therapy can spare people with sickle cell disease from recurrent vaso-occlusive crises, but for the populations that bear most of the global burden of disease, there’s no pathway to such treatment.

In an international cohort of 865 patients, Shwachman–Diamond syndrome was associated with a high risk of myeloid cancer and poor survival. Early hematopoietic stem-cell transplantation for high-risk features had a potential benefit.

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.

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...

In this planned interim analysis of a randomized trial, first surveillance colonoscopy at 5 years after the removal of high-risk adenomas was noninferior to first colonoscopy at 3 years for the incidence of colorectal cancer.

Among children with high-risk B-cell acute lymphoblastic leukemia, two cycles of blinatumomab led to a higher 4-year event-free survival than two cycles of chemotherapy (83.0% vs. 70.3%), with a lower risk of serious infection.

For patients with esophageal cancer, 5-year survival has improved in recent decades but rarely exceeds 20%. This review summarizes risk factors, screening, and treatment for the two main histologic types.

Research involving the treatment of pediatric acute lymphoblastic leukemia (ALL) established the paradigm for improving survival in cancer. In iterative clinical trials conducted by cooperative groups, long-term survival has improved from less than 10% to 90% owing to the use of improved multidrug regimens and treatment tailored to clinical and...

This feature about colorectal cancer screening in a 46-year-old man offers a case vignette accompanied by two essays, one recommending screening by colonoscopy and the other supporting use of a stool-based test.

A 62-year-old woman with a history of stroke and metastatic breast cancer that was being treated with immunomodulator therapy presented with memory loss, confabulation, anhedonia, ataxia, and weight loss. A diagnosis was made.

Colonoscopy surveillance after the removal of adenomas is a cornerstone of the prevention of colorectal cancer. Guidelines in the United States and Europe have endorsed surveillance beginning at 3 years after the removal of advanced adenomas (defined as ≥1 adenoma with a diameter of ≥10 mm, high-grade dysplasia, or villous...

Virus-induced immune thrombocytopenia and thrombosis after HAdV-B3 infection supports a shared platelet factor 4–targeted immune mechanism linking natural adenovirus infection and adenoviral vector–associated disease.

In this prospective trial, patients with serrated polyps had a low 5-year risk of colorectal cancer (1.0%).

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.

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.

This study emphasizes the need to dispel misconceptions and create awareness about HPV vaccine across all strata of the society.

The NADIR model demonstrates robust and reproducible discrimination, calibration, and prognostic stratification in a distinct ARPI‐treated mHSPC cohort, supporting its potential utility for early response risk stratification and trial enrichment pending prospective validation of model‐guided treatment adaptation.

Cilta‐cel remains effective in frail RRMM, but frailty is associated with reduced survival and increased toxicity, supporting tailored CAR‐T strategies.

These results indicate that salvage regimen should be proposed in this context, allowing 50% of patients to achieve CR2 and have better survival.

Trials with late‐stage incidence end points that are conducted using these principles should support the development of evidence‐based screening guidelines as well as the creation of accessible data resources for observational and modeling studies.

Cancer incidence was stable among males but increased slowly among females. Cancer mortality continued to decline, largely because of sustained progress against lung cancer.

These findings suggest oral VitC as a safe, biologically active intervention in patients with early‐stage myeloid malignancies and precursor conditions. A phase 3 trial is warranted.

The past decade has seen many advances in the treatment of haematological malignancies, particularly with the rise of immunotherapies and CAR T-cell therapies. Other treatments, such as tyrosine kinase inhibitors for chronic myeloid leukaemia, have changed the disease to that of a chronic condition, treated with continuously administered therapies that have unique adverse events over time. With these changes, how adverse events are measured, reported, and the patient's perception of these adverse effects needs to be updated as well.

In modern haematology, toxicities often persist long after completion of treatment regimens. Advances in overall survival, alongside the expanded adoption of continuous dosing regimens, immunotherapies, and cellular therapies, have rendered adverse events a lasting burden for patients throughout remission, chronic disease management, and long-term survivorship. Yet the standard Common Terminology Criteria for Adverse Events (CTCAE) maximum grade only records toxicity at its worst point, rather than its persistence, recurrence, cumulative burden, or short-term or long-term effects on daily life.

We thank Ankur Jain for their thoughtful comments regarding our FAIR trial1 and the discussion regarding the prevention of anaemia during pregnancy.2 Our findings show that, among women with non-anaemic iron deficiency diagnosed at the first antenatal care visit, intravenous iron was superior to 30 mg daily oral iron in preventing maternal anaemia. We take the opportunity to address the points raised in the Correspondence.

Dr Steven McKenzie (Cardeza Foundation for Hematologic Research, Philadelphia, PA, USA) and colleagues presented the ALATHEA trial (NCT05785819) that compared the safety and efficacy of 200 mg intravenous VLX-1005 every 12 h (a small-molecule inhibitor of 12-lipoxygenase) versus placebo in patients with suspected heparin-induced thrombocytopenia undergoing standard-of-care treatment with a direct thrombin inhibitor. 24 patients were randomised 1:1 to the two treatment groups; 22 received study treatment and 17 had confirmed HIT (eight received VLX-1005 and nine placebo).

On June 12, 2026, WHO released its latest global report on blood safety and availability, drawing on data from 168 countries. Voluntary unpaid donors now account for 85% of blood donations. Total blood collections increased by 19% from 2013 to 2023 across 132 countries. Nonetheless, governance and oversight remain patchy. 48 countries do not have specific legislation addressing the safety and quality of blood and blood products for transfusion, while 62 countries have not established systems for regular inspection of blood transfusion services.

Nepal, a landlocked country in south Asia bordered by China and India, is known for its geographical, cultural, and religious diversity. It is the only country with a living goddess—The Kumari—a chosen pre-menarcheal girl from Newar community worshipped by all Nepalis, including the head of state. But among this diversity is the belief around menstruation (although differing between region, cast, and culture) that leads to nearly 89% of Hindu women and girls in Nepal to experience some form of menstrual restriction.

When politics and reproductive health intersect, women, girls, and people with the potential to menstruate can be substantially impacted, as seen recently in the USA. The devastating effects of undermining and defunding women's health programmes have generated worthy media attention; however, progress in reproductive health is less fêted. As an example, Ireland has emerged as a progressive voice for women's health despite the persistence into the 21st century of highly restrictive, conservative legislation shaped by historical religious influences on society.

I was remembering all the times I wanted to talk to my dad to ask him about what was happening to me, but he avoided it every time. He did not want to accept that I also needed special medical care. It hurt me a lot to see my dad suffering because of haemophilia, but it hurt me even more not to feel accepted or seen by him.

Epcoritamab plus rituximab–lenalidomide showed high activity in first-line treatment for follicular lymphoma, with 95% of patients having a response over 3 years of follow-up, supporting this treatment regimen as a promising approach that warrants further analysis to ascertain its role in this setting.

The addition of venetoclax to DA-EPOCH-R resulted in excess mortality, prompting early study closure. Robust accrual shows that prospective multicentre trials are feasible in double-hit lymphoma, and the outcomes in the DA-EPOCH-R group serve as a benchmark for future studies.

We showed that allo-HSCT is an effective and potentially curative treatment option for patients with hepatosplenic T-cell lymphoma; auto-HSCT is frequently followed by relapse and might be only recommended to patients with a complete response and ineligible for allo-HSCT.

The results of this study showed the feasibility of rapid multicentre decentralised manufacturing and delivery of fresh CAR T-cell therapy in heavily pretreated B-cell non-Hodgkin lymphoma. The phase 2 part of ATALANTA-1 will provide further information on clinical activity and safety.

With more potent and novel treatment options, the number of survivors of haematological malignancies is increasing steadily, which in turn leads to the need for parallel improvements in survivorship monitoring and care. The present paper forms part of The Lancet Haematology Series on adverse event reporting, dedicated to improving adverse event assessment in haematological malignancies. Here, we review current survivorship care practice from a global perspective and conclude that access to long-term care plans is highly heterogeneous, with insufficient adaptation to the specific needs of haematological malignancy survivors treated curatively or non-curatively.

The therapeutic landscape of haematological malignancies has evolved rapidly with the introduction of targeted therapies, immunotherapies, and cell-based and gene-based interventions, leading to improved survival and, in some cases, long-term remission or cure. These advances have exposed limitations in traditional approaches to adverse event assessment and reporting. Building on the 2025 Lancet Haematology Series on adverse event reporting, this Series paper examines how proposed improvements in toxicity reporting can be operationalised and integrated into regulatory decision making across clinical trials and real-world settings.

Real-world data are essential for understanding treatment-related toxicities in haematology, but traditional analyses are limited by data access, sharing constraints, and reduced data granularity. Emerging digital health technologies (DHTs), such as electronic patient-reported outcomes and wearable devices, can be used to capture continuous, patient-generated data not reliably captured by current post-marketing toxicity assessments. Artificial intelligence, synthetic data, and digital twins can be used to predict and simulate toxicity at a much larger scale beyond the capacity of traditional methodologies.

A 34-year-old man was admitted to Ruijin Hospital (Shanghai, China) in December, 2024, with acute onset of unexplained high fever and a 1-year history of mild splenomegaly. Laboratory testing showed rapidly progressive leukocytosis with 36% circulating blasts and thrombocytopenia. Abdominal ultrasonography verified splenomegaly, with the spleen measuring 156 mm in length and 58 mm in thickness.

For many challenging hematologic disorders, clinical trials provide the best option for management of a patient’s condition. However, access is a barrier, especially for those living away from major centers, which typically are the hosts for many major trials. Removing the distance barrier would accelerate accrual and completion, while broadening the enrolled patient population to better reflect the true pool of unmet need. Petrone, Uy, and Bolton discuss the principles and practicalities of decentralized clinical trials in this Perspective article, providing their experience in an interventional trial to illustrate how the time is right for greater emphasis on this more patient-centric approach.

It is a common occurrence. Moderate and severe thrombocytopenias are regularly induced by cytotoxic chemotherapy regimens in common use across hematology and oncology. Most patients do not need prophylaxis or treatment, but some do. How to identify these patients and how to manage them in an evidence-based way are tackled by Al-Samkari and Soff. Using 4 cases as illustrations, they provide practical, evidence-based advice on the use of thrombopoietin receptor agonists in challenging settings.

In relapsed mantle cell lymphoma (MCL), the combination of ibrutinib and venetoclax improves progression-free survival, but not overall survival, when compared with ibrutinib monotherapy, with the greatest benefits in patients with adverse genetic features. In this month’s CME article, Wang and colleagues report single-arm trial data for first-line use of this regimen in patients at least 65 years old or with TP53 mutations, revealing high and durable complete responses in non-TP53-mutant MCL and a 55% complete response rate but less durability in TP53-mutant MCL. While impressive compared to historical data with chemotherapy-based regimens, the data indicate that this regimen is not the solution for TP53-mutant MCL and novel approaches are urgently required.

Deletion of chromosome 17p [del(17p)]/TP53-mutant multiple myeloma (MM) remains a significant unmet clinical need despite the rapid recent advances in therapy. Using a knockout screen and analyses of publicly available genomic and transcriptomic data, Schavgoulidze and colleagues identified PKMYT1, a member of the Wee family of kinases known to regulate mitotic entry and protect genome integrity, as a vulnerability for TP53-deficient MM. They demonstrate that it is pharmacologically tractable, with inhibition being highly active against patient-derived xenografts and in immunocompetent murine models, creating key evidence supporting clinical study of this targeted approach.

FMS-like tyrosine kinase 3 (FLT3) mutations, typically internal tandem duplications, occur in approximately one-quarter of all acute myeloid leukemias (AMLs), and outcomes have improved significantly with the addition of FLT3 inhibitors. In relapsed disease, the combination of the FLT3 inhibitor gilteritinib and venetoclax is highly active, but recurrence is inevitable. Exploiting serial samples and single-cell techniques, Kennedy and colleagues report the clonal and nonclonal mechanisms of resistance leading to these relapses. Under this therapeutic pressure, RAS-pathway activation is favored, and downstream inhibitors of this pathway may have a future role in controlling or preventing recurrent leukemia.

Juvenile myelomonocytic leukemia (JMML) is a rare myeloproliferative neoplasm that occurs exclusively in young children. It is underpinned in >90% of cases by germ line or somatic mutations in RAS-pathway genes, but elevated inflammatory signaling is a hallmark. Pasupuleti et al explored the basis for this, pinpointing interleukin-17A (IL-17A) as promoting an immunosuppressive microenvironment conducive to treatment-refractory disease. They show that genetic or pharmacological disruption of IL-17A in murine models reverses much of the pathology of JMML, suggesting that clinical trials of the antipsoriasis therapy secukinumab are a logical next step.

Red blood cells (RBCs) must be deformable, and this is enabled by the nature of their cell membrane, a lipid bilayer traversed by integral membrane proteins, such as Band 3. Using proteomics and functional experiments, Issaian et al reveal biliverdin reductase B (BLVRB) as a new Band 3 partner, showing that it translocates to, or dissociates from, the RBC membrane as oxygenation conditions change. Their data demonstrate a novel functional axis involving BLVRB–Band 3 in metabolic remodeling of RBCs in response to exercise and to deoxygenation.

The SMAD4 transcription factor mediates TGF-β signal transduction and is frequently inactivated in pancreatic cancer (PC). This study evaluated SMAD4 (protein) expression in the NRG Oncology/RTOG 9704 phase III trial comparing post-operative chemotherapy-chemoradiation combination regimens for resectable PC. It is hypothesized that higher SMAD4 expression correlates with lower distant metastasis (DM) and improved overall survival (OS).

Preclinical data suggest that fractionated stereotactic radiotherapy (FSRT) may sensitize immunologically-cold tumors to immune checkpoint inhibition by stimulating neoantigen release and that inhibition of interleukin-6 (IL-6) permits immunosuppressive tumor-associated macrophages to become immunostimulatory. This study aimed to test the safety and efficacy of the combination of tocilizumab (anti-IL6R), atezolizumab [anti-programmed death-ligand 1 (PD-L1)], and FSRT in patients with recurrent glioblastoma (rGBM).

Xevinapant, an oral inhibitor of apoptosis proteins, improved locoregional control and survival when added to cisplatin-based chemoradiation therapy in a phase 2 randomized trial of patients with unresectable, locoregionally advanced head and neck squamous cell carcinoma.1,2 Whether this benefit extends to the postoperative setting with concurrent chemoradiation therapy remains unknown. We opened an investigator-initiated, single-arm phase 2 trial (NCT06145412) to evaluate the safety and feasibility of xevinapant (200 mg daily) with adjuvant chemoradiation therapy (60-70 Gy with weekly cisplatin 40 mg/m2), followed by adjuvant xevinapant (200 mg daily), in patients at very high risk of recurrence after surgery.

Breast lymphedema (BL) is a complication after breast-conserving therapy in breast cancer. There is a paucity of data on the risk factors and diagnostic criteria for BL. The purpose of this study was to assess which factors predict clinical BL, and whether changes in mammographic skin thickness can be used to detect BL.

Pain response to palliative radiation therapy is often temporary; some require reirradiation. Whether the previous radiation therapy response is associated with response to reirradiation within the same lesions remains unclear. This study compared pain response rates to palliative reirradiation between patients with previous response and recurrent pain in the same lesion (“previous responders”) and those with persistent or progressive pain after no response to previous radiation therapy (“previous nonresponders”).

For many years after the concept of using proton radiation therapy for the treatment of cancer by Robert Wilson in 1946,1 there was little progress. This was due to many factors, including the lack of machine availability, enough biological information, and technical know-how for routine treatment. That situation changed dramatically when the use of the 160 MeV Harvard cyclotron, built between 1946 and 1949, had decreasing utility for physics research. Raymond Kjellberg, a neurosurgeon at the Massachusetts General Hospital (MGH),2,3 following the work of Lars Leksell at the Gustav Werner Institute in Uppsala, Sweden,4 began using single-fraction ablative surgical stereotactic approaches for pituitary ablation, initially mostly for patients with breast cancer.

Prostate-specific antigen (PSA) kinetics following testosterone recovery remain difficult to interpret in patients treated with definitive radiotherapy (RT) with androgen deprivation therapy (ADT). We evaluated the association between post-testosterone recovery PSA dynamics and progression and metastatic outcomes using Bayesian joint modeling.

Aesthetic outcomes following breast-conserving therapy are critical determinants of quality of life, yet current evaluation methods are limited by the subjectivity of existing scales and substantial interobserver variability. We aimed to evaluate the concordance of large vision-language model assessments with expert consensus, their run-to-run repeatability, and their performance across independent external cohorts as a potential adjunct for breast cosmesis assessment.

Prognosis of leptomeningeal dissemination (LMD) in IDH-wildtype glioblastoma (GBM) patients is dismal, but prognostic factors and optimal treatment strategy for LMD are still not clearly defined. This multi-institutional study aims to analyze clinical factors that affect the outcomes of GBM patients with LMD.

The enrollment of Black patients (BP) in cancer-related clinical trials has recently declined and its etiology remains poorly understood. We aim to characterize psychosocial factors that influence patients with curative gastrointestinal, thoracic, gynecological, and head and neck malignancies when enrolling in a research trial, to improve recruitment and retention of BP.

Re-irradiation (reRT) is increasingly common but lacks clear guidance due to challenges in fitting traditional toxicity models. This pilot study investigates lung density changes on CT as a potential image-based lung radiosensitivity (iRS) biomarker to guide reRT.

This prospective, double-blind, placebo-controlled, randomized clinical trial evaluated the role of memantine in preventing cognitive decline following radiotherapy (RT) for brain metastases (BM).

To develop consensus guidelines for radiation therapy target volume delineation in skull base chordoma.

Radiation-associated lower cranial neuropathy (LCNP) is a debilitating late complication among head and neck cancer (HNC) survivors, leading to progressive dysphagia, aspiration, and loss of nutritional independence. No proven therapies exist for LCNP. This phase I/II dose-finding trial (STOP LCNP, NCT04151082) and parallel registry study prospectively evaluated the safety, feasibility, tolerability, and symptomatic response of high-dose corticosteroid therapy for radiation-associated LCNP.

: Knowledge-based planning (KBP) frequently requires manual refinement to satisfy institution-specific clinical constraints, while existing automated approaches based on large language models (LLMs) or reinforcement learning (RL) each face distinct limitations in long-term optimization awareness and scalability. We propose a hybrid LLM-guided modular RL framework that integrates the strengths of both approaches for automated lung IMRT treatment planning.

Proton minibeam (pMB) radiotherapy, delivers highly heterogeneous dose distributions alternating high-dose peaks and low-dose valleys. This aims to widen the therapeutic window by improving normal tissue sparing while maintaining the same or even better tumour control. The performance of pMB strongly depends on the collimator design and physical parameters. To better understand the physical and radiobiological drivers of this enhanced therapeutic window, we perform a detailed microdosimetric characterization of proton minibeams and assess their impact.

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

A deep learning foundation model was able to predict pneumonitis risk from immune checkpoint inhibition therapy in patients with non–small cell lung cancer (NSCLC) based on baseline computed tomography (CT) scans, according to findings published in the Journal for ImmunoTherapy of Cancer. 

Cancer death rates fell for both men and women from 2019 to 2023, continuing a downward trend that has lasted more than 20 years, according to the 2026 Annual Report to the Nation on the Status of Cancer, published by Henley et al in the journal Cancer. The continued decline in cancer deaths is...

Among patients with ductal carcinoma in situ (DCIS) who underwent breast-conserving surgery, negative surgical margins narrower than 2 mm were not associated with a significantly higher risk of ipsilateral recurrence compared with margins of at least 2 mm—except among patients younger than age...

A pembrolizumab/olaparib strategy significantly improved progression-free survival in patients with newly diagnosed BRCA-nonmutated advanced epithelial ovarian cancer, although overall survival was not improved. Ignace Vergote, MD, PhD, and colleagues reported results from the phase III...

Cleveland Clinic London has appointed Heather Shaw, MD, FRCP, as Oncology Vice Chief, reinforcing the organization’s commitment to expanding access to advanced, multidisciplinary cancer care in the United Kingdom.

The biennial World Cancer Congress, organized by the Union for International Cancer Control (UICC), is the leading international conference on cancer control, bringing together researchers, clinicians, advocates, policymakers, and people with lived experience from more than 120 countries. Two...

The International Agency for Research on Cancer (IARC) has published a comprehensive international evaluation on lung cancer screening in The New England Journal of Medicine.

Colorectal cancer, once thought of as mainly a disease of the aging, is rising in younger adults by nearly 3% per year and is now a leading cause of cancer-related death among individuals under the age of 50.¹ According to the American Cancer Society, in 2026, nearly 159,000 individuals will be...

The U.S. Food and Drug Administration (FDA) recently announced a broad, nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees. The FDA is publishing two Federal Register notices: one seeking qualified scientific, technical, and...

Depression in patients with cancer may be associated with a higher mortality risk, according to findings from a large SEER-Medicare analysis presented at the 2026 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 195). The analysis found that psychotherapy soon after...

Many patients with early-stage breast cancer do not consistently maintain the long-term hormone therapy prescribed after lumpectomy, a large U.S. insurance claims analysis indicates. Findings provide important real-world context for treatment approaches that consider omitting radiation therapy,...

According to results from a post hoc analysis of the SYMPRO-Lung trial published in The Lancet Oncology, weekly patient-reported outcome (PRO) symptom monitoring may be associated with improved long-term overall survival among patients across all stages of lung cancer. Hassing et al reported that...

Mindfulness-based cancer recovery and Tai Chi/Qigong were associated with improvements in fatigue and pain interference among distressed individuals who had completed cancer treatment, with Tai Chi/Qigong also improving sleep quality, according to findings from the Mindfulness and Tai Chi for...

AI is one of the most transformative technological advancements of our time, poised to revolutionize every aspect of our lives, including health care. On August 28, 2026, Cleveland Clinic in collaboration with the College of Healthcare Information Management Executives (CHIME), will host the Second ...

Artificial intelligence (AI) is one of the most transformative technological advancements of our time, poised to revolutionize every aspect of our lives, including health care.

Artificial intelligence could reshape health care by reducing administrative work, helping physicians identify and manage disease, and extending care beyond traditional clinical settings—potentially allowing caregivers to focus more on patient care and human interaction, according to Cleveland...

Five-treatment stereotactic body radiation therapy (SBRT) may offer an effective alternative to surgery for patients with localized prostate cancer. In long-term follow-up findings from the phase III PACE-A trial presented at the 2026 American Society for Radiation Oncology (ASTRO) Annual Meeting (

Tuesday, September 29, 2026 12:30 PM

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Cancer Statistics 2026: What Every Medical Oncologist Should Know

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Short-Course SBRT Better Preserves Physical Function Before Pancreatic Cancer Surgery

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Ultra–Low-Dose Radiation Therapy May Relieve Bone Pain From Multiple Myeloma

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New Prognostic Model May Improve Risk Classification in Metastatic Clear Cell RCC

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Adding Targeted Immunotherapy to Pembrolizumab in Recurrent or Metastatic HPV16-Positive Head and Neck Squamous Cell Carcinoma

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SRS Is a "Reasonable Option" for Patients With SCLC and Brain Metastases

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.

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

Radiation oncology involves complex, data-intensive clinical workflows, which makes this medical specialty an ideal setting for leveraging the unique capabilities of artificial intelligence (AI). The authors of this Review present examples of successful AI applications in radiation oncology, present the current challenges for successful clinical implementation of these applications and discuss broader implications, such as the need to ensure safe and optimal use of AI in order to improve patient outcomes.

Tambotatug pelitecan — a potential new second-line treatment option for SCLC

The extracellular matrix (ECM) has a role in all aspects of cancer progression and thus provides a rich source of potential tumour biomarkers and therapeutic targets. Nonetheless, early efforts at clinical translation have failed to provide ECM-specific clinical tools or therapies. In this Review, the authors describe novel technologies and how these are being leveraged to better inform our understanding of the role of the ECM in cancer development and progression as well as how this new knowledge and capabilities might lead to novel biomarkers and/or ECM-targeting therapies.

Publisher Correction: Antibody–drug conjugates in gynaecological cancers: opportunities and challenges

A new chimeric antigen receptor (CAR) T cell product consists of autologous T cells expressing an affinity-tuned glypican 3-targeted CAR and armoured to secrete a dominant-negative TGFβ receptor II. This cell product was tested in 36 patients with hepatocellular carcinoma and, although the initial efficacy results were promising, antigen loss and limited progression-free survival remain concerns. Here we discuss what else is needed to bring CAR T cells for solid tumours into the clinic.

Preliminary efficacy with daraxonrasib demonstrated in RAS-mutant NSCLC

Publisher Correction: Beyond cold to hot: oncolytic virotherapy as the next cornerstone of immuno-oncology

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The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2 study of AMT-130 underestimates disease progression.

Ten patients out of 20 who received Johnson & Johnson and Legend Biotech’s Carvykti remained alive at five years of follow up.

While Acadia Pharmaceuticals’ candidate has missed the main goal of a Phase 2 trial, the company is still moving forward with the anti-psychosis candidate in Alzheimer’s disease as well as Lewy body dementia.

Analysts were keen to see a new modality compete with Roche’s approved drug Lucentis in the late-stage trial but new safety issues could complicate the future for Merck’s candidate.

Kyverna Therapeutics’ miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application, William Blair said on Thursday. The biotech plans to file for priority review this year.

After imeroprubart failed to demonstrate sufficient efficacy in lupus during a Phase 2b trial, Immunovant is moving on from the indication and looking to other high priority programs for the drug in neurology, endocrinology and rheumatology.

With just over $10 million in cash available to fuel operations through the end of the year, Longeveron is undertaking a strategic review after the failure of a cardiovascular study.

The TREM2 stabilizer failed to show efficacy in a Phase 2 trial of patients with early-stage ALS. This development follows two late-stage trial failures reported by Novartis last week, plus the news that the pharma has paused multiple CAR T cell trials following patient deaths.

The polycythemia vera field is heating up, with Disc Medicine and Silence Therapeutics each advancing next-generation therapies, playing catch-up to Takeda and Protagonist Therapeutics, who won the FDA’s approval last month for Mimrylo.

The enrollment pause comes after BHV-7000 failed to show efficacy in a midstage depression trial late last year. The news is another regulatory hit for Biohaven after the FDA declined to approve its spinocerebellar ataxia treatment in November 2025.

Bristol Myers Squibb will soon release Phase 3 data for admilparant that could make or break Contineum Therapeutics’ rival product. But reports of a death due to liver injury in the pharma’s program have caused some unease about the drug class.

Amid rising industry concerns about U.S. competitiveness with China, the Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection.

The all-stock deal gives Summit Therapeutics enough money to see through Phase 3 trials for the PD-1/VEGF bispecific ivonescimab—but keeps the asset fully in-house without giving up licensing rights.

Kodiak Sciences will head to regulators with one of the candidates, an anti-VEGF antibody called zenkuda, after the late-stage results.

While Acadia Pharmaceuticals’ candidate has missed the main goal of a Phase 2 trial, the company is still moving forward with the anti-psychosis candidate in Alzheimer’s disease as well as Lewy body dementia.

Analysts were keen to see a new modality compete with Roche’s approved drug Lucentis in the late-stage trial but new safety issues could complicate the future for Merck’s candidate.

Kyverna Therapeutics’ miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application, William Blair said on Thursday. The biotech plans to file for priority review this year.

Amgen is awaiting another Phase 3 readout for the investigational Sjögren’s disease therapy, set for later this year. William Blair anticipates that at least two trials will be needed to support an FDA application.

A late-stage test of Roche and Ionis Pharmaceuticals’ sefaxersen showed that the drug reduced protein in the urine, which suggests the RNA-targeting therapy could improve kidney function and delay transplant.

Ulefnersen, an RNA-targeted therapy being developed by Ionis Pharmaceuticals and Otsuka Pharmaceutical, improved measurements of functional impairment and survival in patients with a rare, genetic ALS subtype in a Phase 3 trial. The partners plan to approach the FDA with the results to determine potential pathways for approval.

Kailera Therapeutics and Hengrui Pharma’s weekly injection showed benefits beyond weight loss in a mid-stage trial, leading to more regular menstrual cycles in patients with polyendocrine metabolic ovarian syndrome.

Merck has revealed detailed data for tulisokibart from a mid-stage trial in hidradenitis suppurativa that analysts say could help carve out a place in a crowded market that already includes AbbVie’s Humira and UCB’s Bimzelx.

Bristol Myers Squibb will soon release Phase 3 data for admilparant that could make or break Contineum Therapeutics’ rival product. But reports of a death due to liver injury in the pharma’s program have caused some unease about the drug class.

Amid rising industry concerns about U.S. competitiveness with China, the Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection.

In this episode of Denatured, you’ll hear from Max Bronstein, CEO of Aviva Strategies and Teresa Barnes, Chief Executive Warrior of PF Warriors. We dig into why U.S. patients are losing access to rare disease trials happening abroad and how the FAIR Act’s accelerated, harmonized reviews could help the U.S. keep pace while getting lifesaving studies to patients faster.

Summit Therapeutics scores a $2 billion equity investment from AstraZeneca to support ivonescimab’s late-stage development; uniQure crashes after four-year data from its Huntington’s disease gene therapy failed to impress; Kyverna Therapeutics brings new light to a struggling CAR T space in autoimmune disease.

It’s not enough for organizations to want scientists to think like entrepreneurs. They have to incentivize and reward for that behavior.

The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2 study of AMT-130 underestimates disease progression.

The all-stock deal gives Summit Therapeutics enough money to see through Phase 3 trials for the PD-1/VEGF bispecific ivonescimab—but keeps the asset fully in-house without giving up licensing rights.

Kodiak Sciences will head to regulators with one of the candidates, an anti-VEGF antibody called zenkuda, after the late-stage results.

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). 

On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.

On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.

On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).

On May 27, 2026, the Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

On May 22, 2026, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

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