Bristol Myers Squibb reports phase‑3 trial shows izalontamab brengitecan doubles PFS in EGFR‑mutated NSCLC
Bristol Myers Squibb and partner SystImmune announced that their bispecific ADC izalontamab brengitecan (iza‑bren) achieved a median progression‑free survival (PFS) of 11.1 months versus 5.7 months for platinum‑based chemotherapy in the phase‑3 PANKU‑Lung01 study of previously treated EGFR‑mutated non‑small cell lung cancer. The trial enrolled 216 patients on iza‑bren and 206 on chemotherapy and showed a hazard ratio of 0.40 (95 % CI 0.31‑0.51, p < 0.0001). The drug also produced a confirmed objective response rate of 60.2 % compared with 34.5 % for chemotherapy and demonstrated a manageable safety profile.
Why it matters
The company said the data support advancing iza‑bren toward regulatory submission, but investors noted the trial was conducted in China and overall‑survival data remain immature, limiting immediate impact on the stock. The licensing deal required an $800 million upfront payment and includes up to $7.1 billion in potential milestone payments, which could affect future cash flow if the drug reaches market.
Key facts
- 1Median PFS was 11.1 months for iza‑bren. biospace.com
- 2Median PFS was 5.7 months for platinum‑based chemotherapy. biospace.com
- 3The study enrolled 216 patients on iza‑bren and 206 on chemotherapy. biospace.com
- 4Hazard ratio for progression or death was 0.40 (95 % CI 0.31‑0.51, p < 0.0001). biospace.com
- 5Confirmed objective response rate was 60.2 % for iza‑bren and 34.5 % for chemotherapy. biospace.com
- 6Bristol Myers Squibb paid an $800 million upfront licensing fee and may owe up to $7.1 billion in milestones. fool.com
Summary written by AlphAI AI Desk from 7 of 7 sources. Not investment advice. Figures are as stated by the linked sources.