Shots:
Akeso and Summit has reported the P-III (HARMONi-2/AK112-303) trial data assessing ivonescimab monotx. vs Keytruda in Chinese pts with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression
Trial showed improvement in OS (2EP), with results to be presented in future. In the primary analysis, trial met it 1EP of improved PFS,…
Shots:
Akeso and Summit have reported interim analysis from the P-III (AK112-309/HARMONi-GI1) trial assessing ivonescimab + CT vs durvalumab + CT for the 1L treatment of advanced biliary tract cancer (BTC)
Trial met its 1EP of OS, plus achieved all key 2EPs of PFS & ORR; data will be presented at the academic conference & published…
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;…
Shots:
Summit has initiated P-II/III (HARMONi-GU1) trial of ivonescimab + enfortumab vedotin (EV) against Keytruda + EV as first-line treatment of locally advanced or metastatic urothelial (bladder) cancer
The global, multi-regional trial will enroll ~800 pts through P-III, with site activations beginning later this year. P-II will determine the recommended P-III dose of ivonescimab in…

