Innovent Presents Phase 1b Study Data on IBI310 and Sintilimab at 2024 ASCO Annual Meeting

Innovent Biologics, Inc., a notable player in the biopharmaceutical sector, recently announced significant findings from a Phase 1b clinical trial. This study assessed the efficacy and safety of combining IBI310, an anti-CTLA-4 monoclonal antibody, with sintilimab as a neoadjuvant therapy for colon cancer. This data, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighted promising results that have led to the initiation of a Phase 3 trial named Neoshot.

The study, registered under ClinicalTrials.gov (NCT05890742), involved 101 participants diagnosed with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. These participants were randomized to receive either the combination of IBI310 and sintilimab or sintilimab alone. The results demonstrated that the combination therapy significantly improved the pathologic complete response (pCR) rates compared to sintilimab alone—80.0% vs. 47.7%, with a p-value of 0.0007.

Adverse events related to the treatment were monitored, with treatment-related adverse events (TRAEs) causing surgery delays in two patients (3.8%) receiving the combination therapy and none in the sintilimab-only group. Grade 3 or higher immune-related adverse events (irAEs) were reported in 5.8% of the combination therapy group and 8.2% in the sintilimab group, indicating a manageable safety profile for the combination therapy.

Professor Ruihua Xu of Sun Yat-sen University Cancer Center, the study’s Principal Investigator, emphasized the challenges in achieving complete resection for some stage IIB-III colon cancer patients. He pointed out that neoadjuvant chemotherapy is often ineffective in MSI-H/dMMR colon cancer, with a pCR rate of around 5%. Xu suggested that the dual immunotherapy of IBI310 and sintilimab could potentially change clinical practices by reducing preoperative staging and the scope of radical resection, thereby improving the complete resection rate and long-term prognosis.

Following these encouraging Phase 1b results, Innovent has proceeded with the Phase 3 Neoshot trial in China to further evaluate this combination therapy's effectiveness. Dr. Hui Zhou, Senior Vice President of Innovent, highlighted the significant unmet clinical need for effective neoadjuvant therapies for MSI-H/dMMR colon cancer in China and expressed optimism about the ongoing Phase 3 trial.

IBI310 is a human monoclonal antibody developed by Innovent to target CTLA-4, a protein that inhibits T cell activation and proliferation. By blocking CTLA-4, IBI310 enhances the immune system's response against tumors. Sintilimab, marketed as TYVYT® in China, is a PD-1 monoclonal antibody co-developed by Innovent and Eli Lilly. It works by binding to PD-1 on T-cells, blocking the PD-1/PD-L1 pathway, and reactivating T-cells to attack cancer cells. Sintilimab has been approved in China for multiple indications, including the treatment of various types of cancer.

Innovent Biologics, founded in 2011, is dedicated to making high-quality biologics accessible. With a portfolio that includes cancer, cardiovascular, metabolic, autoimmune, and eye disease treatments, Innovent continues to advance the biopharmaceutical industry through collaborations with global healthcare leaders.

This significant development underscores the potential of IBI310 combined with sintilimab as a groundbreaking neoadjuvant treatment for colon cancer, offering hope for improved patient outcomes.