EGFR-mutated, advanced non-squamous NSCLC (2L+ EGFRm NSCLC)
SMMTSummit TherapeuticsCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Ivonescimab + chemotherapy in EGFR-mutated, advanced non-squamous NSCLC (2L+ EGFRm NSCLC). The expected timing is based on the latest available company guidance and may change.
HARMONi trial. 5/30/25- Favorable Ph3 result announced. Timing of BLA filing to be determined. 9/7/25- Long term follow-up data presented at IASLC'25. 01/12/26:- BLA for ivonescimab plus chemotherapy in 2L+ EGFRm NSCLC submitted in Q4 2025; FDA decision expected Q4 2026. 01/29/26:- FDA accepted BLA for ivonescimab plus chemotherapy; PDUFA action date set for November 14, 2026. 03/27/26:- ELCC 2026 posters show intracranial PFS benefit and HRQoL data. PDUFA still November 14, 2026. 07/22/26:- June 2026 OS update showed HR 0.76; PDUFA remains November 14, 2026.
Verification
Confirm timing and program details against the company announcement or filing.