bristol myers squib (BMS) is a Phase III CheckMate-8HW clinical trial combining Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment option for microsatellite-high instability (MSI-H) or mismatch repair deficiency (dMMR). reported promising data. Metastatic colorectal cancer (mCRC).
This open-label, randomized Phase 3 study was designed to evaluate Opdivo in combination with Yervoy against the investigator’s choice of chemotherapy.
Approximately 830 patients were enrolled and randomly assigned to receive Opdivo monotherapy, Opdivo plus Yervoy, or chemotherapy.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, while chemotherapy regimens include mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab.
The study’s dual primary endpoints focused on progression-free survival (PFS) of Opdivo combination therapy versus chemotherapy in the first-line setting.
The other primary endpoint was PFS in subjects receiving Opdivo alone across all treatments.
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Secondary endpoints included overall survival (OS) and various safety and efficacy measures.
Results showed that the Opdivo regimen reduced the risk of disease progression or death by 79% compared to chemotherapy.
This improvement in PFS was evident from approximately 3 months and was maintained over time.
Additionally, the safety profile of Opdivo plus Yervoy is consistent with previously reported findings, with no new safety concerns reported.
“We are thrilled to be partnering with Bristol-Myers Squibb to support our patients in this field,” said Dana Walker, executive vice president and global program lead for gastrointestinal and genitourinary cancers at Bristol-Myers Squibb. “With research across the CheckMate clinical development program, BMS has revolutionized the oncology landscape and contributed to changing survival expectations for cancer patients.
“These results build on the benefits of Opdivo and Yervoy in MSI-H/dMMR metastatic colorectal cancer previously demonstrated in CheckMate -142, and we are expanding the use of these therapies to help more patients. It reinforces our commitment to exploring possibilities.”
Last month, the company announced plans to discontinue its Phase III RELATIVITY-123 clinical trial of nivolumab and leratolimab to treat microsatellite stable (MSS) metastatic colorectal cancer (mCRC).
