BMS Immuno-Oncology Combination Therapy Designated as Breakthrough Therapy in China for First-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer

Screenshot source:CDE Official Website

Colorectal cancer (CRC) is a malignant tumor that occurs in the colon or rectum. The dMMR phenotype occurs when proteins responsible for repairing mismatch errors during DNA replication are missing or lose function, leading to MSI-H tumors. Public data shows that approximately 5% to 7% of patients with metastatic colorectal cancer have dMMR or MSI-H tumors. These patients are less likely to benefit from traditional chemotherapy and generally have a poor prognosis.

In January 2024, Bristol-Myers Squibb announced the results of the Phase 3 study CheckMate-8HW, which evaluated nivolumab in combination with ipilimumab versus investigator’s choice of chemotherapy (mFOLFOX-6 or FOLFIRI regimens, with or without bevacizumab or cetuximab), forFirst-line treatment for MSI-H or dMMR phenotype metastatic colorectal cancer (mCRC)。The results showed,AndCompared with chemotherapy,Dual Immunotherapy CombinationSignificant efficacy benefits were demonstrated in the first-line treatment of MSI-H/dMMR phenotype mCRC.These latest dataAlreadyIn2024American Society of Clinical Oncology(ASCO) Gastrointestinal Cancers Symposium for oral presentation and was highlighted as part of the official conference news coverage.

Specifically, according to the assessment by the Blinded Independent Central Review (BICR),Nivolumab CombinationIpilimumabThe dual immunotherapy combination demonstrated a statistically and clinically significant improvement in the primary endpoint—progression-free survival (PFS):Compared with chemotherapy, mCRC patients with MSI-H/dMMR phenotype confirmed by central laboratory testing receivedAfter the dual immunotherapy combination`, Risk of Disease Progression or Death`Reduced by 79%.Dual Immunotherapy CombinationOfImprovement in PFS began to appear at around 3 months and continued throughout. Combination therapyThe median PFS of the group has not been reached.，Whereas the chemotherapy group was 5.9 months. Consistent PFS benefits were observed across all pre-specified subgroups, including those withKRASOrNRASPatients with mutations, as well as those with liver, lung, or peritoneal metastases at baseline.The safety profile of the combination therapy was consistent with previously reported data, remained manageable under the established study protocol, and no new safety signals were identified.