In brief

• Research Adjuvant nivolumab does not extend disease-free survival after lung cancer surgery in NCI trial The 935-patient ANVIL trial, published in JAMA, found no disease-free survival benefit from a year of nivolumab after resection of non-small cell lung cancer.
• FDA & Regulatory FDA approves baxdrostat, the first aldosterone synthase inhibitor for hard-to-control hypertension AstraZeneca's once-daily pill, cleared as add-on therapy, lowered systolic pressure by about 9 to 10 mmHg over placebo in the Phase 3 BaxHTN trial.
• Clinical Trials AstraZeneca opens VECTRA-01, a Phase 3 test of alpha-emitter AZD2265 in prostate cancer after beta-emitter therapy The 670-patient global trial pits an actinium-225 PSMA radioligand against standard of care in men who have already received a beta-emitting radioligand.
• FDA & Regulatory FDA grants accelerated approval to bulevirtide, the first US therapy for chronic hepatitis delta The clearance rests on a 150-patient trial showing a combined virologic-and-biochemical surrogate response; whether the drug improves clinical outcomes is still unproven.
• Research In PD-L1-positive gastric cancer, adding serplulimab to surgery chemotherapy delays relapse — but survival data are immature ASTRUM-006, in The Lancet, reports longer event-free survival when the PD-1 antibody serplulimab is added to perioperative chemotherapy, with the benefit shown first in the most PD-L1-rich patients — but overall survival data are not yet mature.
• FDA & Regulatory EMA committee recommends approving Boehringer's nerandomilast for two pulmonary fibrosis indications The CHMP's positive opinion on nerandomilast (Jascayd) spans idiopathic and progressive pulmonary fibrosis, two settings the committee says have limited treatment options.
• Biotech Business Celcuity reports a PIK3CA-mutant breast cancer win for gedatolisib over alpelisib, with the actual numbers due at ASCO on June 2 Celcuity says VIKTORIA-1 hit its progression-free survival endpoint in the PIK3CA-mutant cohort, but the hazard ratio and median PFS stay undisclosed until a June 2 ASCO late-breaking presentation.