BMS Announces FDA Approval of Opdivo plus Yervoy for First-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer, Two Months Ahead of PDUFA Date

Local time on April 8, BMSAnnounced that the U.S. FDA has approvedOpdivo(Nivolumab)UnitedYervoy(Ipilimumab)Used forFirst-line treatment for unresectable or metastatic high microsatellite instability（MSI-H）Or Mismatch Repair Deficiency（dMMR）Adults and children(12 years and above)Colorectal Cancer（CRC）Patient.

The press release shows,This approvalMore than two months ahead of the PDUFA target date. Previously, in October 2024, this indication had been approved for marketing in China.

This FDA approvalMainly based on a Phase IIICheckMate-8HW Study Results. This is a randomized, multi-center, open-label Phase III clinical trial designed toEvaluationEfficacy and Safety of O+Y versus O Drug Alone or Chemotherapy Regimens in MSI-H/dMMR mCRC Patients, with a total of 839 subjects enrolled.

At a median follow-up of 47 months,O+Y can reduce the risk of disease progression or deathReduced by 38%（HR 0.62，95% CI 0.48～0.81，P = 0.0003），The PFS rates at 12 months, 24 months, and 36 months were also higher than those with O monotherapy.(76% vs 63%, 71% vs 56%, 68% vs 51%, respectively)The median PFS for O+Y has not been reached, while for O drug it is 39.3 months. Compared with O drug, the ORR of O+Y has also been significantly improved.（71% vs 58%，P = 0.0011）。

In terms of safety, O+YThe safety profile is consistent with previously reported data and is manageable under the established study protocol, with 22%...3/4 grade treatment-related adverse events (TRAE) were reported in patients treated with O+Y combination therapy and in 14% of patients treated with O monotherapy. No new safety signals were identified.

The efficacy advantage of the O+Y regimen is due to the highly synergistic mechanisms of the two drugs. The CTLA-4 inhibitor Y drug mainly acts during the initiation and activation phases of T cells, promoting T cell activation and proliferation. Its unique immune-modulatory cell clearance function can also help improve the immunosuppressive state of the liver cancer tumor microenvironment, further enhancing the immune anti-tumor effect. Meanwhile, the PD-1 inhibitor O drug primarily functions during the effector phase of T cells, assisting activated T cells in recognizing and killing tumor cells.

Based on its unique mechanism of action and clinical research evidence, O+Y has now been approved for use in multiple cancer types, including pleural mesothelioma, colorectal cancer, and hepatocellular carcinoma.

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