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The following is a summary of “First-in-class bispecific antibody IBI318 (LY3434172) targeting PD-1 and PD-L1 in patients with advanced tumors: a phase Ia/Ib study,” published in the November 2024 issue of Hematology by Ruan et al.
Anti-PD-1/PD-L1-based cancer immunotherapy (IO) has shown promise, but there is a need to improve its response rate and safety.
Researchers conducted a prospective study on IBI318 (LY3434172), a first-in-class bispecific antibody (bsAb) targeting PD-1 and PD-L1 in patients with advanced tumors.
They conducted an open-label, multicenter Phase Ia/Ib study of IBI318. Phase Ia involved dose escalation (0.3 to 1200 mg every two weeks) to determine the recommended phase 2 dose (RP2D), while Phase Ib focused on evaluating safety and efficacy in patients with non-small cell lung cancer (NSCLC) and nasopharyngeal carcinoma (NPC) at the RP2D. The primary endpoint was safety, and secondary endpoints included efficacy (RECIST v1.1), pharmacokinetics, immunogenicity, and pharmacodynamics.
The results showed that 103 patients were enrolled (phase Ia, n = 55; Phase Ib, n = 48) with a median follow-up of 10.1 months (range 0.7–28.6). The RP2D was 300 mg Q2W. Treatment-related adverse events (TRAEs) occurred in 88 patients (85.4%), with 10 patients (9.7%) experiencing grade ≥3 TRAEs. The overall objective response rate (ORR) was 15.5%, and the disease control rate (DCR) was 49.5%. In phase Ib, the confirmed ORR was 45.5% in treatment-naïve patients with NSCLC and 30.0% in patients with IO-naïve NPC.
They found IBI318 to have a favorable safety profile and preliminary efficacy in NSCLC and NPC patients. Further studies were needed to assess its full therapeutic potential.
Source: jhoonline.biomedcentral.com/articles/10.1186/s13045-024-01644-4
