Bristol Myers Iza-Bren Phase 3 PFS Reaches 11.1 Months

BioNTech (BNTX) and Bristol Myers (BMY) reported Phase 2 trial data for pumitamig plus docetaxel in metastatic NSCLC, showing a 36.7% response rate and manageable safety profile. The trial included 50 patients, with 33 still on treatment. Both companies' stocks saw pre-market gains.

SystImmune and Bristol Myers Squibb reported that a Phase 3 trial of izalontamab brengitecan (iza-bren) met its primary endpoint in EGFR-mutated non-small cell lung cancer patients. The trial showed iza-bren achieved a median progression-free survival of 11.1 months compared to 5.7 months for chemotherapy. The drug is jointly developed by the two companies outside of China.

Bristol-Myers Squibb (BMY) reported that its drug izalontamab brengitecan doubled median progression-free survival to 11.1 months compared to 5.7 months with chemotherapy in a phase 3 lung cancer trial. The study involved patients with EGFR-mutated non-small cell lung cancer who had progressed after tyrosine kinase inhibitor treatment. The company noted that overall survival data are not yet mature, and the drug had manageable safety with low discontinuation rates.

Bristol Myers Squibb (BMY) and SystImmune's drug iza-bren showed significant improvement in progression-free survival (PFS) for EGFR-mutated NSCLC in a Phase 3 trial, with median PFS of 11.1 months vs. 5.7 months for the control. The drug demonstrated clinical benefit across five tumor types and has Breakthrough Therapy Designation. BMY plans to advance the treatment if approved.

Bristol Myers Squibb (BMY) presented interim Phase 1 Breakfree-2 study results for zolacabtagene autoleucel (zola-cel) in patients with highly active relapsing and progressive multiple sclerosis. The study showed a safety profile consistent with prior data and promising efficacy, with all patients at dose level 2 remaining off disease-modifying therapies. Secondary endpoints indicated potential for immune reset and disease activity control.

Pathos AI has partnered with Bristol Myers Squibb (BMY) and Tempus (TEM) to advance AI-driven drug development for Alzheimer’s and other neurological conditions. Tempus will create a dataset from hundreds of thousands of patients, which Pathos will license for $55 million over five years. BMY leads Pathos's Series E financing and gains access to Pathos's AI platform, Pathos Foundry, for its R&D portfolio, with exclusive rights in neuroscience for three years.