The EMA has approved the P-Ib/II study to evaluate the safety/tolerance, efficacy, and PK characteristics of GFH925 (KRASG12C inhibitor) + Erbitux (cetuximab) for the treatment of patients with KRASG12C-mutant NSCLC. GenFleet will first open trial sites in the EU and then initiate a similar trial in China with its partner Innovent
The P-I study results of GFH925 monotx. at 600mg, the BID dose showed a better efficacy signal with investigator-assessed ORR (61.9%) & DCR (100%). The results were presented at ASCO and CSCO 2022
GFH925 received the BTD from the NMPA to treat advanced NSCLC patients with KRASG12C mutation that have received one prior line of systemic therapy
Ref: PRNewswire | Image: GenFleet
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