Summit partner Akeso wins China NMPA approval for ivonescimab in EGFR-mutated NSCLC

Summit Therapeutics Inc.

NMPA approved ivonescimab + chemo for EGFR-mutated advanced non-squamous NSCLC after TKI failure.
First regulatory approval for ivonescimab globally; based on HARMONi-A Phase III trial.
Median PFS by IRRC: 7.06 mo (ivonescimab) vs 4.80 mo (chemo alone); HR 0.46 (95% CI 0.34-0.62).
Grade ≥3 TEAEs: 61.5% in ivonescimab arm vs 49.1% in chemo arm; mostly chemo-related.
Approval does not affect Summit's US/global development plan; HARMONi and HARMONi-3 trials continue.

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