Shots:
- Chinese NMPA has approved ivonescimab + CT for the 1L treatment of pts with advanced squamous NSCLC (sqNSCLC), based on the global P-III (HARMONi-6) trial
- The trial, sponsored by Akeso, assessed ivonescimab + CT vs Tevimbra + CT to treat Chinese pts with 1L sqNSCLC irrespective of PD-L1 expression, showing improved OS & PFS; data were presented at ASCO’26
- In 2026, Summit initiated P-II/III (HARMONi-GU1) study in urothelial carcinoma, with global site activations planned from Q4’26. Ivonescimab’s BLA is under FDA review for EGFR-mutated, LA/M nsq-NSCLC previously treated with a third-generation EGFR TKI (PDUFA: Nov 14, 2026)
Ref: Businesswire | Image: Summit and Akeso | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
