The mRNA-based personalized cancer vaccine combined with Keytruda reduced the risk of melanoma death or recurrence by 42% in a late-stage trial, though leaked data triggered a sell-off in Moderna shares despite meeting expectations.
The FDA has granted accelerated approval to dostarlimab-gxly (Jemperli) as monotherapy for adults with previously untreated stage II or III locally advanced rectal cancer with dMMR or MSI-H status, based on interim phase 2 AZUR-1 trial results. This marks a first-in-class approval in this specific type of rectal cancer.
Geraldine Levano, 31, of Houston experienced severe acid reflux during her second pregnancy that doctors dismissed as pregnancy-related. The unbearable symptoms were later diagnosed as stage 3 colon cancer, highlighting the dangers of dismissing persistent or severe symptoms during pregnancy.
Verastem Oncology announced encouraging early results for its KRAS G12D inhibitor in pancreatic cancer patients alongside a $250 million fundraise and CEO departure, positioning itself as a competitor to Revolution Medicines in next-generation KRAS treatments.
A randomized clinical trial found that adding metastasis-directed ablation (focused radiation or surgery) to first-line systemic therapy did not improve progression-free or overall survival in patients with oligometastatic breast cancer. Two-year overall survival was 88.4% with systemic therapy alone versus 78% with ablation added.
Researchers at Dana-Farber Cancer Institute and 23andMe Research Institute have identified a rare inherited mutation in the Epidermal Growth Factor Receptor (EGFR) gene that increases lung cancer risk by 25-fold, helping explain why 10-20% of U.S. lung cancer cases occur in people who never smoked.
A prospective study of 1,785 individuals across four countries shows the PANXEON exosome-based biomarker, combined with CA 19-9 levels, achieves high sensitivity for detecting early-stage pancreatic ductal adenocarcinoma. The investigational test, developed by researchers at City of Hope, could enable detection when the disease is more treatable.
The IMpower030 trial showed that adding perioperative atezolizumab to platinum-based chemotherapy nearly doubled median event-free survival in patients with stage IIB-IIIB resectable non-small cell lung cancer without EGFR mutations, but the drug missed its primary endpoint.
Revolution Medicines' breakthrough pill targeting KRAS mutations in advanced pancreatic cancer received FDA approval, priced at over $475,000 per year. The drug nearly doubles survival in patients with this hard-to-treat cancer.
AstraZeneca discontinued a Phase 3 trial combining its experimental bispecific antibody volrustomig with chemotherapy for lung cancer after an interim data review indicated survival goals would likely not be met. This marks another setback for the company's pipeline as it pursues an $80 billion sales target.
Taiho Oncology and Cullinan Therapeutics announced their next-generation EGFR inhibitor zipalertinib significantly improved progression-free survival in a registrational phase 3 trial for first-line treatment of advanced non-small cell lung cancer. The results position the drug as a competitor to multiple approved medicines in the EGFR-mutated lung cancer market.
Pathos AI announced two significant licensing agreements for breast cancer treatments: a $2.2 billion deal with China's Alphamab Oncology for bispecific ADC JSKN016 targeting triple-negative breast cancer, and a co-exclusive agreement with AstraZeneca for ERα degrader AZD4241 for ER-positive breast cancer. The company is reportedly planning to raise a Series E round at a $3 billion valuation.
The FDA has approved Novartis' radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for use in combination with hormone therapy for patients with PSMA-positive metastatic prostate cancer who are still hormone-sensitive, nearly doubling the eligible patient population from its previous indication for hormone-resistant cases.
Scientists at the University have created a new human tissue model that tracks how glioblastoma, an aggressive brain tumor, infiltrates surrounding brain tissue. The research aims to address the challenge of tumor recurrence after surgery, when remaining cells cause the cancer to return.
The FDA has approved SimpleScreen CRC, a blood-based screening test for colorectal cancer, marking the second such test to receive approval. The less invasive option aims to improve screening uptake as colorectal cancer cases rise approximately 3 percent annually in adults under 50.
Phase III CLARITY-Gastric01 trial results showed sonesitatug vedotin (Sone-Ve) achieved statistically significant overall survival improvement in CLDN18.2-positive advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma patients in second-line and later settings, meeting its dual primary and key secondary endpoints.
The U.S. Food and Drug Administration has approved Revtorpyk (gedatolisib), Celcuity's first drug to reach market, for treating hormone receptor positive, HER2 negative advanced breast cancer. The approval sent the company's shares up 7% in extended trading.
Engineered silica nanoparticles caused prostate cancer tumor cells to self-destruct and activated immune response in preclinical mouse studies. Combined with immunotherapy, the treatment showed promising results against aggressive disease.
Roche announced positive results from a head-to-head Phase 3 trial showing its KRAS G12C inhibitor divarasib demonstrated superior efficacy compared to competing treatments from Amgen and Bristol Myers Squibb in patients with KRAS-driven lung cancer.
China's National Medical Products Administration has approved satricabtagene autoleucel (Satri-cel, CT041, Kaileimei®), marking the first CAR-T cell therapy approved globally for treating solid tumors, specifically for CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction adenocarcinoma.
The FDA has approved the combination of belzutifan (Welireg) and pembrolizumab (Keytruda) as adjuvant treatment for patients with clear cell renal cell carcinoma at high risk of recurrence following nephrectomy, based on data from the phase 3 LITESPARK-022 trial.
New clinical trial results presented at the American Society of Clinical Oncology show that Moderna's experimental personalized mRNA vaccine, combined with immunotherapy, significantly reduced the risk of deadly melanoma returning after five years. The vaccine is custom-made for each patient based on their specific tumor.
J&J's Erleada used with hormone-blocking therapy six months before and after prostate surgery improved cancer elimination rates and reduced the risk of cancer spread and death in a late-stage trial for prostate cancer patients.
Novartis reported early data showing its experimental actinium-based radiopharma drug demonstrated anti-tumor activity against prostate cancer, including in patients previously treated with its older therapies.
Scientists have developed a DNA test that can distinguish between breast cancer patients who are likely to benefit from chemotherapy and those who can safely avoid it, potentially sparing millions from unnecessary treatment.
Chinese innovative drug NHWD-870 has received Breakthrough Therapy Designation for NUT carcinoma, a rare and aggressive cancer that has historically had very poor outcomes. The designation represents a significant milestone for patients with this previously untreatable condition.
New research shows rectal cancer mortality rates among older millennials are rising faster than colon cancer deaths, with the disease striking earlier and killing faster, suggesting need for earlier screening in younger patients.
Clinical trial results demonstrate that immunotherapy as first-line treatment provides clinical benefit for patients with advanced colorectal cancer, offering an alternative to chemotherapy for a disease increasingly affecting younger patients.
Revolution Medicines presented new positive clinical trial data at AACR for its KRAS-targeting drug in pancreatic cancer patients, building on previously reported breakthrough survival results and expanding evidence for a novel class of treatments beyond current KRAS inhibitors.
Global phase III TROPION-Breast02 trial led by National Cancer Centre Singapore shows datopotamab deruxtecan significantly improves survival outcomes in triple-negative breast cancer patients, representing a major breakthrough for this aggressive cancer type.
A large UK trial published in the New England Journal of Medicine found that women's hormone replacement therapy patches can treat prostate cancer just as effectively as standard hormone injections but with fewer severe side effects.
The Health Resources and Services Administration released new guidelines Monday expanding cervical cancer screening options to include self-collected vaginal samples for HPV testing, offering an alternative to traditional Pap smears for women ages 30-65 at average risk. Most private insurance plans will be required to cover the testing without cost sharing.
