Phase 3 Neoshot Trial Begins with Dosing for MSI-H/dMMR Colon Cancer

Innovative Biopharmaceuticals, a leading company in developing and commercializing high-quality drugs for various diseases, including oncology and autoimmune disorders, has made a significant advancement in the treatment of MSI-H/dMMR colon cancer. The company has initiated a Phase 3 clinical trial, known as Neoshot, which is a first of its kind in China. This trial involves the use of IBI310, an anti-CTLA-4 monoclonal antibody, in combination with sintilimab, a PD-1 inhibitor, for neoadjuvant therapy in patients with resectable MSI-H/dMMR colon cancer.

The primary goal of the study is to assess the safety and efficacy of the combined immunotherapy approach compared to traditional adjuvant chemotherapy following surgery. The trial's main objectives are to measure the rate of pathologic complete response (pCR) and event-free survival (EFS). Encouraging results from a previous Phase 1b study, where the pCR rate was notably higher in the IBI310 and sintilimab combination group compared to the monotherapy group, set the stage for this Phase 3 trial. Importantly, the earlier study showed no increase in safety risks with the combination treatment.

Prof. Ruihua Xu, Principal Investigator of the Neoshot study and an expert from Sun Yat-sen University Cancer Center, emphasized the need for effective neoadjuvant treatment options. The existing challenges with R0 resection for T4 and/or N+ stage colon cancer patients, along with the limited effectiveness of neoadjuvant chemotherapy, highlight the urgency for new treatment strategies. The combination of IBI310 and sintilimab has shown promise in improving preoperative staging, reducing tumor burden, and increasing the rate of successful R0 resection, potentially leading to better long-term outcomes for patients.

Dr. Zhou Hui, Senior Vice President at Innovative Biopharmaceuticals, highlighted the significant unmet clinical need for neoadjuvant therapy for resectable MSI-H/dMMR colon cancer in China. The positive results from the Phase 1b study and the potential translation of postoperative pCR rate into survival benefits, as suggested by the NICHE study, underscore the importance of the Neoshot trial.

Colorectal cancer remains a significant health concern in China, being the second most common malignant tumor and the fourth leading cause of cancer-related deaths. The incidence has been on the rise, with MSI-H/dMMR occurring more frequently in localized rather than metastatic colorectal cancer. The prognosis for MSI-H/dMMR stage III colon cancer patients is notably poorer, making the development of improved perioperative treatments imperative.

IBI310 is a fully human monoclonal antibody developed by Innovative Biopharmaceuticals that targets the CTLA-4 antigen, enhancing T cell activation and proliferation, and thereby improving the immune response against tumors. Sintilimab, co-developed with Eli Lilly and Company, is a PD-1 inhibitor that reactivates T-cells to target cancer cells. It has been approved in China for several indications and has shown promising results in clinical studies.

Innovative Biopharmaceuticals, established in 2011, is dedicated to making high-quality biologics accessible and affordable. With a robust pipeline of drugs in various stages of development and partnerships with over 30 global healthcare leaders, the company is committed to advancing the biopharmaceutical industry and improving patient outcomes.