Multicenter phase 1a/1b trial of the bispecific antibody IBI318 targeting PD-1 and PD-L1 for advanced tumors

There is an unmet clinical need to enhance the response rate and safety of anti-PD-1/PD-L1 based cancer immunotherapy (IO). A multicenter phase 1a/1b study in China evaluated the bispecific antibody IBI318 (LY3434172) in 103 patients with advanced tumors. In phase 1a (n=55), patients received IBI318 in doses ranging from 0.3 to 1200 mg every two weeks. As recommended phase 2 dose (RP2D) 300 mg every two weeks was selected. With this dose 48 patients with advanced non-small cell lung cancer (aNSCLC) or advanced nasophyngeal cancer (aNPC) were treated in cohorts with varying treatment histories. Among all 103 patients, the objective response rate was 15.5% and the disease control rate was 49.5%. In phase 1b, the confirmed objective response rate was 45.5% in treatment-naïve aNSCLC and 30% in IO-naïve aNPC. The authors conclude that IBI318 demonstrated a favorable safety profile and preliminary efficacy in selected aNSCLC and aNPC patients.