Therapy Areas: Oncology
Innovent Biologics doses first participant with IBI310 in combination with sintilimab in Phase three clinical trial
27 March 2024 -

Innovent Biologics, Inc. (HKEX: 01801), a China-based biopharmaceutical company, announced on Tuesday that it has successfully dosed its first participant with IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab (PD-1 inhibitor) in a randomised, controlled, multicentre Phase three clinical trial (Neoshot), for resectable MSI-H/dMMR[1] colon cancer (stage cT4 or cN+) neoadjuvant therapy.

Neoshot is the first Phase 3 clinical trial (NCT05890742) in China to investigate MSI-H/dMMR colon cancer neoadjuvant immunotherapy. The study will evaluate the safety and efficacy of IBI310 combined with sintilimab for neoadjuvant therapy, compared with adjuvant chemotherapy after radical surgery for MSI-H/dMMR colon cancer.

The study's primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS).

The Neoshot study's principal investigator, Prof. Ruihua Xu from Sun Yat-sen University Cancer Center, said: "At present, R0 resection for T4 and/or N+ stage colon cancer patients remain a significant challenge, along with risks of extensive trauma and poor prognosis. The results of the FOxTROT study suggested that neoadjuvant chemotherapy is not effective in MSI-H/dMMR colon cancer, and the pCR rate is only about 5 percent. Therefore, effective neoadjuvant treatment scheme is urgently needed to reduce preoperative staging, decrease tumour burden, narrow the scope of radical resection, and increase R0 resection rate, so as to improve long-term prognosis. IBI310 combined with sintilimab is expected to be the first neoadjuvant immunotherapy in China for resectable MSI-H/dMMR colon cancer, which has demonstrated encouraging efficacy and a good tolerance profile in a Phase 1b study. I look forward to working together with other investigators in Neoshot to obtain high-quality clinical data, in support of potentially providing a more effective treatment option for patients with MSI-H/dMMR colon cancer in China."