Bristol Myers Squibb Announces Phase 3 CheckMate-8HW Trial Met Primary Endpoint of Improved PFS in First-Line MSI-H/dMMR Metastatic Colorectal Cancer

▎WuXi

Edited by Kant Content Team

Bristol-Myers Squibb today announced positive results from the Phase 3 clinical trial CheckMate-8HW. The trial evaluated the efficacy and safety of its重磅 PD-1 inhibitor Opdivo (nivolumab) in combination with the CTLA-4 targeted antibody Yervoy (ipilimumab), compared to investigator’s choice of chemotherapy, as a first-line treatment for patients with metastatic colorectal cancer (mCRC). These patients have tumors that are either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

The dual primary endpoints of the trial are progression-free survival (PFS) as assessed by blinded independent central review (BICR) for Opdivo plus Yervoy combination therapy compared to investigator’s choice of first-line chemotherapy, and PFS as evaluated by BICR for the combination therapy compared to Opdivo alone across all treatment lines.According toThe pre-specified interim analysis assessed by BICR showed that the trial achieved one of its primary endpoints, demonstrating a statistically and clinically significant improvement in PFS with the dual immunotherapy combination of Opdivo and Yervoy compared to chemotherapy.The trial is ongoing to evaluate PFS (another primary endpoint) as well as secondary endpoints for the combination therapy compared to Opdivo monotherapy.

The safety profile of the Opdivo plus Yervoy combination is consistent with previously reported data, adverse reactions can be managed with established protocols, and no new safety signals were identified in the trial.

Opdivo is a PD-1 immune checkpoint inhibitor designed to help restore anti-tumor immune responses.

, utilizing the human body's own immune system to combat cancer. Yervoy targets and inhibits CTLA-4. CTLA-4 antibodies enhance tumor-killing ability by boosting T-cell activity. This product received FDA approval in 2011 for the treatment of advanced melanoma and is the world’s first approved CTLA-4 antibody drug.

[1] Bristol Myers Squibb Announces Phase 3 CheckMate -8HWTrial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Compared toChemotherapy in Microsatellite Instability–High or Mismatch Repair DeficientMetastatic Colorectal Cancer Meets Primary...Retrieved December 7, 2023 from https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibb-Announces-Phase-3-CheckMate--8HW-Trial-Evaluating-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Compared-to-Chemotherapy-in-Microsatellite-InstabilityHigh-or-Mismatch-Repair-Deficient-Metastatic-Colorectal-Cancer-Meets-Primary/default.aspx

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