China-based Innovent Biologics Inc. (HKG: 1801) announced the presentation of two clinical studies at the 2022 European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO).
IBI939 Phase Ib Study Results
A Phase Ib study to evaluate the safety, tolerability, and efficacy of anti-TIGIT candidate IBI939 in combination with sintilimab in patients with previously untreated locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC). IBI939 is a recombinant fully human anti-T-cell immunoreceptor monoclonal antibody with Ig and ITIM domains (TIGIT) developed by Innovent Biologics. As of October 15, 2022, 42 patients were randomized (2:1) to receive IBI939 plus sintilimab (experimental arm) or sintilimab monotherapy (control arm). The confirmed objective response rate (ORR) was 64.3% vs 57.2% and the disease control rate (DCR) was 85.7% vs 78.6% in the experimental and control arms respectively. The median progression-free survival (PFS) was 11.2 months (95%CI, 6.7-NA) in the experimental arm vs 6.4 months (95% CI, 1.4-NA) in the control arm (HR: 0.55). For safety results, the incidence of treatment-related adverse events (TRAEs) was 96.4% vs 71.4% in the experimental arm vs control arm respectively. No grade 5 TRAE occurred in the experimental arm.
IBI110 Phase Ib Study Results
Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with sintilimab in advanced squamous NSCLC: updated results from a Phase Ib study. IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody developed by Innovent Biologics. The Phase Ib study aims to evaluate the efficacy and safety of IBI110 in combination with sintilimab and chemotherapy (paclitaxel plus carboplatin) as first-line therapy for advanced sqNSCLC. As of the data cutoff date of Oct 25, 2022, the objective response rate (ORR) was 80%, the 12-month progression-free survival (PFS) rate was 60.0% (95% CI, 35.7-77.6), and the median PFS was not reached. The 12-month overall survival (OS) rate was 85.0% (95% CI, 60.4-94.9). For safety results, the most common treatment-related adverse events (TRAEs) ≥ grade 3 were decreased neutrophil count (30%) and decreased white blood cell count (20%). No treatment-related deaths occurred.-Fineline Info & Tech
