The U.S. Food and Drug Administration (FDA) has released a new draft guidance to streamline the development of biosimilars. This, and prior versions of the draft guidance for industry, reflect actions being taken by the agency to lower the cost of drugs. “Streamlining biosimilar development...
In an Italian single-center phase II trial (SURE-02) reported in The Lancet Oncology, Necchi et al found that neoadjuvant sacituzumab govitecan-hziy plus perioperative pembrolizumab produced a “promising” clinical complete response rate in patients with muscle-invasive bladder cancer who were...
The 2025 San Antonio Breast Cancer Symposium (SABCS 2025) featured some exciting presentations. The early breast cancer highlights at SABCS 2025 included the landmark lidERA trial, which explored the efficacy of the oral selective estrogen receptor degrader (SERD) giredestrant in the adjuvant...
In a European phase II/III trial (AXINET) reported in the Journal of Clinical Oncology, Garcia-Carbonero et al found that the addition of axitinib to long-acting octreotide appeared to show activity in patients with advanced extrapancreatic neuroendocrine tumors (epNETs). Study Details The...
In a study of adults with advanced prostate cancer taking androgen-receptor pathway inhibitors (ARPIs) and different types of anticoagulants, investigators found no evidence of an increase in patients’ bleeding or clotting risks, despite previous lab results that raised alarms. These findings were...
Peter WT Pisters, MD, President of The University of Texas MD Anderson Cancer Center, was honored with the Charles M. Balch, MD, Distinguished Service Award at the Society of Surgical Oncology (SSO) 2026 Annual Meeting in recognition of his substantial contributions and leadership in the field...
Building upon the foundation of liquid biopsy utility for the early detection of cancer, analysis of genome-wide cell-free DNA fragmentation with machine learning classification and modeling can also extend to the identification of liver cirrhosis and other chronic diseases, according to findings...
In a Chinese phase II trial (CHANCE2005/CARES-005) reported in the Journal of Clinical Oncology, Zhu et al found that the addition of camrelizumab and rivoceranib to transarterial chemoembolization (TACE) improved progression-free survival in patients with unresectable hepatocellular carcinoma....
Researchers have identified that the reporting of venous and arterial thrombotic events in cancer clinical trials is inconsistent and potentially inaccurate, according to a comments article published in the Journal of Clinical Oncology.1 “Mandatory and uniform reporting of all [venous and arterial...
As reported in The Lancet by Harada-Shoji et al, the Japanese J-START trial showed that adjunctive ultrasonography was associated with a reduced cumulative incidence of advanced breast cancer vs mammography alone in screening of asymptomatic women aged 40 to 49 years. Initial reports from the trial ...
Quadrivalent human papillomavirus (HPV) vaccination led to a significantly reduced risk of invasive cervical cancer that was sustained through long-term follow-up, according to the results of a Swedish nationwide, register-based cohort study published in The BMJ. “This study provides evidence of...
As reported in the Journal of Clinical Oncology by Scherpereel et al, 5-year findings from the phase III CheckMate 743 trial showed continued overall survival benefit of first-line nivolumab plus ipilimumab vs chemotherapy in patients with unresectable pleural mesothelioma. Study Details In the...
On March 5, 2026, the U.S. Food and Drug Administration (FDA) approved teclistamab (Tecvayli) in combination with daratumumab hyaluronidase-fihj for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a...
A novel KRAS G12D inhibitor produced disease control in almost 80% of patients with heavily pretreated advanced or metastatic KRAS G12D–mutated pancreatic cancer in an early-phase study reported at the 2026 ASCO Gastrointestinal (GI) Cancers Symposium.1 Of 41 evaluable patients treated with...
Short-term exposure to low-dose vaginal estrogen therapy may relieve some symptoms of menopause for younger survivors of endometrial cancer without increasing the risk of endometrial cancer recurrence, according to findings from a study published in Menopause. “Early detection and improved,...
In a retrospective study reported in The Lancet Oncology, Lalchungnunga et al tested the classification accuracy of a molecular inference–based artificial intelligence (AI) model (Neuropath-AI) in central nervous system (CNS) tumor diagnosis. Study Details The multi-institutional study included...
A large national study in Denmark following nearly 1,900 patients over almost a decade found that minimally invasive ablation is as effective as surgery for treating small kidney cancers, with faster recovery and fewer complications. Results of the study were published by Ahrenfeldt et al in...
Prompts on posts with social cues—such as messages indicating how many users have flagged a post—and clear platform review policies may encourage intervention and reduce sharing of cancer treatment misinformation on social media, according to Lazard et al, who reported findings from their online...
Findings from the American Cancer Society's triennial report, Colorectal Cancer Statistics, 2026, show that rates of colorectal cancer are decreasing in older adults; however, rates of colorectal cancer incidence in younger adults continue to increase, with a greater proportion of these cancers...
Artificial intelligence (AI) tools that detect molecular biomarker status from histologic images may be dependent upon correlational relationships with clinicopathologic features, preventing the models from learning the true causal effect of the biomarker, according to findings published in Nature...
Matthew D. Galsky, MD, FASCO, of Mount Sinai Tisch Cancer Center, discusses findings from the randomized phase III KEYNOTE-B15/EV-304 study, which is evaluating neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab followed by radical cystectomy plus pelvic lymph node dissection vs...
Thomas Powles, MD, PhD, FCRP, of Barts Cancer Centre, Queen Mary University of London, shares findings from the phase II RC48G001 trial of disitamab vedotin, an antibody-drug conjugate comprising a novel anti-HER2 antibody, disitamab, and an MMAE payload. The agent demonstrated “promising antitumor ...
In a phase II trial (TRANSCEND FL) reported in The Lancet, Palomba et al found that the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel was active in patients with relapsed or refractory marginal zone lymphoma (MZL). Study Details In the international multicenter trial, 67...
As reported in The New England Journal of Medicine by Vulsteke et al, the phase III KEYNOTE-905/EV-303 trial has shown improved event-free and overall survival with the addition of perioperative enfortumab vedotin plus pembrolizumab to radical cystectomy in patients with muscle-invasive bladder...
Combining a visual inspection of the bladder—systematic endoscopic evaluation—with a blood test to check for the presence of circulating tumor DNA (ctDNA) may accurately predict which patients with bladder cancer still have cancer in their bladder after treatment and which do not. These findings,...
In 2015, LH, a 66-year-old female, was diagnosed with chronic lymphocytic leukemia (CLL), Rai stage 0. Untreated, the woman’s lymphocyte count rose from 5,000/mm3 to 16,000/mm3 in 6 years (doubling time = 4.2 years). She was then advised to stop eating red meat (see the figure). Commercially...
In an individual patient data meta-analysis reported at the 2026 ASCO Genitourinary Cancers Symposium (Abstract 305) and simultaneously published in The Lancet, Kishan et al found no apparent overall survival benefit of adding hormone therapy in patients undergoing postoperative radiotherapy after...
Advanced-stage follicular lymphoma is currently considered incurable. But a new analysis of long-term data from patients treated for the disease years ago with standard regimens of immunotherapy and a chemotherapy combination known as CHOP suggests that many of those patients can now be considered...
In a new study published in Clinical Gastroenterology and Hepatology, Johnson et al reported that an automated artificial intelligence (AI) pipeline using large language models (LLMs) can accurately stratify future risk of advanced neoplasia in patients with colitis-associated low-grade dysplasia....
Circulating tumor DNA (ctDNA) may be used to predict metastatic risk and identify which patients with muscle-invasive bladder cancer are more likely to benefit from a bladder-sparing treatment approach, according to findings from the RETAIN trials presented at the 2026 ASCO Genitourinary Cancers...
Based on the results from the phase III KEYNOTE-564 study, adjuvant pembrolizumab is currently standard of care for patients with clear cell renal cell carcinoma at increased risk of recurrence following a nephrectomy. Now, the results from the phase III LITESPARK-022 study—which investigated the...
At the 2026 ASCO Genitourinary Cancers Symposium, Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, presented results from the second interim analysis of the phase III LITESPARK-011 trial showing improved progression-free survival, higher objective response rate, and a trend toward...
Researchers have found that using a form of radiation therapy that targets individual tumors rather than whole-brain radiation is more optimal for patients with brain metastases, even if a larger number of tumors are present. These findings could help improve quality of life and cognitive function...
Skin fluorescent imaging showed high sensitivity and specificity for the discrimination of low- and high-risk lesions, demonstrating an alternative, noninvasive approach to melanoma biopsies, according to findings from a phase II trial published in JAAD International. “By identifying the molecular ...
The results from the randomized phase III KEYNOTE-B15/EV-304 study show that neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab significantly improved event-free survival, overall survival, and pathologic complete response rate in patients with muscle-invasive bladder cancer who were...
In time for the assigned deadline of February 23, 2026, medical societies, companies, health-care systems, and more have responded to a request for information from the Department of Health and Human Services (HHS) regarding the use of artificial intelligence (AI) in clinical practice. The Request...
On February 26, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zongertinib (Hernexeos), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 tyrosine kinase domain ...
Amar Kishan, MD, University of California, Los Angeles, discusses results from an individual patient data meta-analysis of randomized trials to quantify the benefit of adding hormone therapy to postoperative radiotherapy in patients with localized prostate cancer after radical prostatectomy...
Enrique Gallardo, MD, of Parc Taulí University Hospital, presents final overall survival results from the EORTC 1333/PEACE-3 trial, which is a phase III trial evaluating the addition of radium-223 to enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone...
Anna Clare Wilkins, PhD, MRCP, MBBChir, of The Institute of Cancer Research, discusses the external validation of a digital pathology-based multimodal artificial intelligence (MMAI)-derived prognostic biomarker using data from the phase III CHHiP trial. CHHiP evaluated conventional vs...
Scott Tyldesley, MD, FRCPC, of BC Cancer Vancouver, reports on the 15-year survival analysis from the ASCENDE-RT trial, which randomly assigned patients to receive either prostate brachytherapy or the external-beam radiotherapy boost; both arms also received androgen-deprivation therapy....
Prostate specific antigen (PSA) screening remains one of the most controversial of “standard” medical practices. As recently as the 2026 Super Bowl, one of the more unusual TV advertisements, sponsored by a pharmaceutical company with an interest in prostate cancer treatments, extolled the virtues ...
Among the high-quality abstract presentations at the annual San Antonio Breast Cancer Symposium (SABCS), a few always stand out as particularly meritorious. Each year, The ASCO Post asks its Senior Deputy Editor, breast cancer specialist Jame Abraham, MD, FACP, to offer his top picks for most...
Each year in the United States, about 90,000 adolescents and young adults (AYAs), ages 15 to 39, are diagnosed with cancer,1 and they are immediately faced with myriad challenges and disruptions in their life stages, including psychosocial distress; interruptions in their education, career, and...
In a European retrospective study (PORTAL) reported in The Lancet Oncology, Soeterik et al developed a nomogram for predicting androgen-deprivation therapy (ADT)–free survival with metastasis-directed stereotactic body radiotherapy (SBRT) in patients with prostate-specific membrane antigen (PSMA)...
In a study reported in JAMA Oncology, Rakaee et al identified the accuracy of open-source artificial intelligence (AI) models in predicting the presence of EGFR mutations in samples from patients with lung adenocarcinoma, including according to ancestral subgroups. Study Details The study included...
In a study reported in the Journal of Clinical Oncology, Zhao et al found that patients with non–small cell lung cancer (NSCLC) in Medicaid expansion states have had improvements in earlier diagnosis, early initiation of treatment, and survival. Study Details In the study, patients newly diagnosed...