China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has revealed positive results from a Phase II interim analysis of its drug candidate APL-1202, combined with BeiGene Ltd’s (NASDAQ: BGNE; HKG: 6160) programmed death-1 (PD-1) inhibitor tislelizumab, as neoadjuvant chemotherapy (NAC) in muscular invasive bladder cancer (MIBC). The trial has demonstrated synergistic effects of APL-1202, the world’s first oral and reversible MetAP2 inhibitor in clinical use, alongside PD-1 inhibition in bladder cancer pharmacodynamic models.
Phase I/II Study Design and Approvals
The Phase I/II study received approval in the US in June 2021 and was cleared in China three months later. The study is designed to assess the efficacy and safety of the APL-1202 and tislelizumab combination as NAC in MIBC, with the primary endpoint being pathological complete remission (pCR). According to the study protocol, the trial will progress to the next stage if at least 5 out of the first 18 evaluable subjects in the combination therapy group and at least 3 out of the first 14 evaluable subjects in the tislelizumab monotherapy group achieve pCR.
Interim Analysis and Safety Monitoring Committee Review
An interim analysis of the efficacy was performed when both groups completed the first stage. Both groups have met the requirements of Simon’s optimal design for the first stage efficacy in the second stage trial, and have entered the second stage. After reviewing the interim analysis data, the Safety Monitoring Committee (SMC) determined that the results met the preset requirements, indicating a positive direction for the study.-Fineline Info & Tech
