Iza-Bren Doubles PFS to 11.1 Months in EGFR-Mutated NSCLC Phase 3
BMY sits 46% above its 52-week low of $42.52.
Summary
Bristol Myers Squibb and partner SystImmune reported a prespecified interim analysis from the Phase 3 PANKU-Lung01 study in which iza-bren, a first-in-class EGFRxHER3 bispecific ADC, cut the risk of progression or death by 60% versus chemotherapy in previously treated EGFR-mutated NSCLC. Median PFS by blinded review was 11.1 months versus 5.7 months (HR 0.40, p<0.0001), with confirmed response rates of 60.2% versus 34.5% and median duration of response of 10.4 versus 5.7 months. Overall survival data remain immature but trend favorably, and the safety profile showed no new signals, with only 1.9% of patients discontinuing for treatment-related adverse events and adjudicated ILD at 0.9%. The data were presented at ESMO 2026 and published in The Lancet, and iza-bren already holds FDA Breakthrough Therapy Designation in this indication. This is a meaningful pipeline win for BMY's oncology franchise, which has been rebuilding around growth assets; iza-bren is now backed by positive Phase 3 data across five tumor types, though the China-sponsored trial means a US regulatory package and filing timeline are the next gating items.
At the time of this announcement, BMY was trading at $62.01 on NYSE in the Life Sciences sector, with a market capitalization of approximately $125.6B. 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 7 out of 10. Source: BusinessWire.