Innovent Doses First Patient in Phase 3 Colon Cancer Trial

Innovent Biologics (HKEX: 01801) has dosed the first participant with IBI310 in combination with sintilimab in a randomized, controlled, multicenter Phase 3 clinical trial for resectable MSI-H/dMMR[1] colon cancer (stage cT4 or cN+) neoadjuvant therapy. Innovent’s study is the first Phase 3 clinical trial in China to investigate MSI-H/dMMR colon cancer neoadjuvant immunotherapy.

Dr. Zhou Hui, Senior Vice President of Innovent, commented, “There is a huge unmet clinical need for neoadjuvant therapy of resectable MSI-H/dMMR colon cancer in China. The results of our NICHE study showed that postoperative pCR rate after neoadjuvant treatment for locally advanced colon cancer can be well translated into survival benefits.

“In the Phase 1b study, IBI310 combined with sintilimab achieved excellent efficacy and safety results. We are pleased that the Phase 3 clinical study has completed the first patient dosing, and we are looking forward to the positive results generated from this study to provide a more ideal treatment option for MSI-H/dMMR colon cancer patients in China.”

Highlights

Innovent’s 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 primary endpoints are pathologic complete response rate and event-free survival.

Previously, in a randomized, controlled, multicenter Phase 1b study for neoadjuvant therapy in patients with resectable MSI-H/dMMR colon cancer, the pCR rate in the IBI310+sintilimab group was significantly higher as compared with the sintilimab monotherapy group.

Colorectal cancer is the second most common malignant tumor and the fourth leading cause of cancer death in China. In 2022, there were more than 510,000 new cases and approximately 240,000 fatal cases of colorectal cancer.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase 3 or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center.

Guided by the motto, “Start with Integrity, Succeed through Action,” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

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Innovent Doses First Patient in Phase 3 Colon Cancer Trial

Catie Corcoran

Biotech Editor