other material
confidence high
sentiment positive
materiality 0.75
Summit: Ivonescimab gets second NMPA approval in China; OS hazard ratio 0.777
Summit Therapeutics Inc.
- NMPA approved ivonescimab for front-line PD-L1+ advanced NSCLC based on HARMONi-2 Phase III trial.
- Interim OS analysis showed hazard ratio 0.777 (22% reduction in risk of death) at 39% data maturity.
- Primary endpoint PFS previously showed HR 0.51 (p<0.0001) favoring ivonescimab over pembrolizumab.
- Summit is enrolling HARMONi-7, a multiregional Phase III trial of ivonescimab vs pembrolizumab in same population.