INNOVENT BIO(01801): The new drug application for the combination of Ipilimumab injection with Sintilimab injection for neoadjuvant therapy of colorectal cancer has been accepted by the National Medical Products Administration and included in priority review.

INNOVENT BIO (01801) announced that the new drug application (NDA) for the adjuvant therapy of ipilimumab injection (anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody, research and development code: IBI310) in combination with sintilimab for resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients has been accepted and included in the priority review process by the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). Ipilimumab is the first Chinese-developed CTLA-4 monoclonal antibody to submit an NDA, and this is another milestone for sintilimab to establish its leading position in tumor immunotherapy. The acceptance and priority review of this NDA is based on the results of a randomized, controlled, multicenter, Phase III registration study conducted in China (NeoShot, NCT05890742). The study aims to evaluate the efficacy and safety of ipilimumab in combination with sintilimab as adjuvant therapy for resectable MSI-H/dMMR colorectal cancer compared to direct curative surgery. The primary endpoints of the study are pathological complete response rate (pCR) and event-free survival (EFS). Mid-term analysis of the NeoShot study shows that the pre-specified primary study endpoints were met as evaluated by the Independent Data Monitoring Committee (IDMC), and the relevant study results are planned to be published in future academic conferences or journals. Previously, the results of a randomized, controlled, open-label phase Ib study of adjuvant therapy with ipilimumab in combination with sintilimab for MSI-H/dMMR colorectal cancer were presented in oral form at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Based on these results, ipilimumab has been included in the breakthrough therapy drug (BTD) list by CDE. Results from the FOxTROT study suggest that the efficacy of neoadjuvant chemotherapy in MSI-H/dMMR colorectal cancer is suboptimal, with a pCR rate of approximately 5%. CTLA-4 and PD-1 are two major milestone targets in the field of tumor immunotherapy, and the combination of sintilimab and ipilimumab can increase the complete resection rate of colorectal cancer, achieve pathological complete response, alleviate most patients from the burden of postoperative adjuvant chemotherapy, and potentially reduce recurrence rates and improve long-term prognosis. The new indication application for market approval is expected to benefit MSI-H/dMMR colorectal cancer patients as soon as possible. The company remains committed to consolidating its leading position in the field of oncology treatment and driving innovative treatment solutions through innovation and collaboration.