Ivonescimab plus chemo gets NMPA approval in China for EGFRm NSCLC; PFS HR 0.46 in HARMONi-A

Summit Therapeutics Inc.

NMPA approved ivonescimab + chemo for 2L+ EGFR-mutant non-squamous NSCLC based on HARMONi-A Phase III trial sponsored by Akeso.
PFS hazard ratio 0.46 (p<0.001); median PFS 7.1 months vs 4.8 months for placebo + chemo.
ORR 50.6% vs 35.4% and DCR 93.1% vs 83.2%; OS trended positive (HR 0.72 at 10.2 mo follow-up).
Subgroup with 3rd-gen TKI: PFS HR 0.48; safety manageable — 5.6% discontinued ivonescimab due to TRAEs.
Multi-regional HARMONi trial (target 420 patients) enrolling; completion expected in H2 2024.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.