Gelonghui September 25th | YAHONG Medicine (688176.SH) announced that the company's APL-1202 oral combined with toripalimab as neo-adjuvant therapy for muscle-infiltrating bladder cancer (MIBC) phase I/II clinical trial has completed phase II and achieved positive therapeutic signals. The main objective of this phase II clinical trial is to evaluate the safety and efficacy of the combination of APL-1202 and toripalimab compared to toripalimab monotherapy as neo-adjuvant therapy in MIBC subjects. The study population includes subjects who are newly diagnosed with MIBC and planned to undergo radical cystectomy, as well as subjects who are intolerant or refuse to undergo platinum-based neo-adjuvant chemotherapy. The primary efficacy endpoint of the trial is the pathological complete response rate. Pathological complete response (pCR) is defined as histopathological evaluation of bladder and lymph node specimens after cystectomy to confirm no residual tumor lesions in the bladder and lymph node metastasis.

The results of this phase II clinical trial show that the combination treatment of APL-1202 and toripalimab demonstrates positive therapeutic signals compared to toripalimab monotherapy, while also showing acceptable safety characteristics. In the population of baseline centrally pathologically diagnosed as MIBC (modified evaluable analysis set, mEAS), the pCR of the combination treatment group of APL-1202 and toripalimab was 41% (9/22), and the pCR of the toripalimab monotherapy group was 20% (4/20). The results of this study provide strong support for the company's further development of APL1202 in combination therapy with immune checkpoint inhibitors in the field of bladder cancer. The company is actively preparing for communication with domestic and foreign drug regulatory agencies to advance the late-stage clinical development of this therapy. Detailed data on this clinical trial will be presented at upcoming relevant academic conferences.