Phase 3 trial shows izalontamab brengitecan nearly doubles PFS in EGFR‑mutated lung cancer
Bristol Myers Squibb and SystImmune reported that their dual‑targeting EGFRxHER3 bispecific ADC, izalontamab brengitecan (iza‑bren), met its primary endpoint in the PANKU‑Lung01 Phase 3 study. The drug extended median progression‑free survival to 11.1 months versus 5.7 months for platinum‑based chemotherapy, a 60% reduction in the risk of disease progression or death. The trial enrolled 422 patients and showed a confirmed objective response rate of 60.2% compared with 34.5% for chemotherapy, with a manageable safety profile.
Why it matters
The company said the data support continued development and could lead to regulatory approval, which may add a new revenue stream to BMY’s oncology portfolio. Investors will watch the upcoming regulatory review and potential label expansion.
Key facts
- 1Median progression‑free survival was 11.1 months for iza‑bren versus 5.7 months for chemotherapy. stocktitan.net
- 2Hazard ratio for progression or death was 0.40 (95% CI 0.31‑0.51; p < 0.0001). investing.com
- 3Confirmed objective response rate was 60.2% for iza‑bren and 34.5% for chemotherapy. grafa.com
- 4The randomized trial enrolled 422 patients (216 received iza‑bren, 206 received chemotherapy). grafa.com
- 5Grade ≥ 3 treatment‑related adverse events led to discontinuation in 1.9% of iza‑bren recipients. grafa.com
- 6Iza‑bren has received Breakthrough Therapy Designation from the U.S. FDA for previously‑treated advanced EGFR‑mutated NSCLC. stocktitan.net
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.