Pfizer, AstraZeneca, Revolution Medicines line up ivonescimab combos ahead of FDA decision
- AstraZeneca will test ivonescimab with Datroway (TROP2 ADC, with Daiichi Sankyo) starting in first-line triple-negative breast cancer, and with CLDN18.2 ADC sone-ve in GI cancers; Pfizer plans pairings with its vedotin ADCs including Padcev.
- Revolution Medicines offered its RAS(ON) inhibitors, among them zoldonrasib and elironrasib, as partners for RAS-mutant tumors; Summit says more collaborations are under discussion.
- FDA is due to decide on ivonescimab in second-line non-squamous NSCLC on November 14; final HARMONi-3 progression-free survival data are expected before year-end.
- Analysts at Mizuho and Stifel are bullish, while AstraZeneca notes most positive data are China-only.
💡 Points Based on public reports
Partners queuing for combo trials before any US approval is a bet that PD-1xVEGF becomes a backbone, and it gives Summit leverage beyond monotherapy sales. But each ADC pairing multiplies toxicity and dosing unknowns, and AstraZeneca's China-only caveat hints that a Western HARMONi-3 readout, not the November 14 decision, is the real test of the backbone thesis.
Drugmakers rush to pair up with Summit's ivonescimab ahead of key verdict ↗