Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the first subject dosing in the randomized, multi-center Phase III Neoshot study for its anti-CTLA-4 monoclonal antibody IBI310. The study combines IBI310 with the PD-1 inhibitor sintilimab as a neoadjuvant treatment for patients with resectable MSI-H/dMMR colon cancer (stage cT4 or cN+).
The Neoshot trial is the first Phase III clinical trial in China (NCT05890742) to explore neoadjuvant immunotherapy for MSI-H/dMMR colon cancer. It aims to evaluate the safety and efficacy of the combination therapy of IBI310 and sintilimab compared to adjuvant chemotherapy following radical surgery for MSI-H/dMMR colon cancer. The primary endpoints of the study are pathologic complete response (pCR) rate and event-free survival (EFS).
Sintilimab, a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company, works by binding to PD-1 molecules on the surface of T-cells, blocking the PD-1/PD-L1 pathway, and reactivating T-cells to effectively target and kill cancer cells.
In China, sintilimab has received approval and has been included in the National Reimbursement Drug List (NRDL) for seven indications, marking a significant milestone in expanding access to this innovative immunotherapy for various cancer types.- Flcube.com
