Iza-Bren Cuts Progression Risk 59% in Phase 3 HR+/HER2- Breast Cancer
BMY sits 47% above its 52-week low of $42.52.
Summary
Iza-bren, the EGFRxHER3 bispecific ADC Bristol licenses from SystImmune outside China, hit its primary endpoint in the Phase 3 PANKU-Breast01 study. Median PFS was 8.2 months versus 4.0 months for chemotherapy, a 59% reduction in the risk of progression or death (HR 0.41, p<0.0001), with confirmed ORR of 40.5% versus 20.2%. Safety looked manageable: 1.6% of patients discontinued for treatment-related adverse events and adjudicated ILD occurred in two patients (1.1%). The data were presented at ESMO and published in The Lancet, and iza-bren now has positive Phase 3 results across five indications, including triple-negative breast cancer and EGFR-mutant NSCLC, where it holds FDA Breakthrough Therapy Designation. This is a meaningful pipeline win for a company that has leaned on growth assets like Eliquis and its CAR-T franchise, and it strengthens the case for a broad ADC label; the Zola-Cel CAR-T pause in September showed how quickly sentiment can swing on clinical data. Overall survival was immature at this interim look, so the next read is mature OS data plus any regulatory filing timeline for this indication.
At the time of this announcement, BMY was trading at $62.55 on NYSE in the Life Sciences sector, with a market capitalization of approximately $128.7B. The 52-week trading range was $42.52 to $68.64. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.