Bristol Myers Squibb (BMS) has reported promising data from the Phase III CheckMate -8HW clinical trial of Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line therapy option for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).
The open-label, randomised Phase III trial is designed to evaluate Opdivo in combination with Yervoy against the investigator’s choice of chemotherapy.
It enrolled approximately 830 patients, randomly assigned to receive either Opdivo monotherapy, Opdivo plus Yervoy, or chemotherapy.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor while chemotherapy regimen comprised mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab.
A dual primary endpoint of the trial focused on comparing the progression-free survival (PFS) of the Opdivo combination regimen to chemotherapy in the first-line setting.
Other primary endpoint was PFS in subjects who received Opdivo alone across all lines of therapy.
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The secondary endpoints included overall survival (OS) and various safety and efficacy measures.
The results revealed that the Opdivo regimen offered a 79% decline in the disease progression or mortality risk versus chemotherapy.
This PFS improvement was evident from around three months and was maintained over time.
Moreover, the safety profile of the Opdivo plus Yervoy regimen was in line with priorly reported findings, without any new safety concerns reported.
Bristol Myers Squibb gastrointestinal and genitourinary cancers global programme lead and vice-president Dana Walker said: “With research from the full CheckMate clinical development programme, BMS has revolutionised the oncology landscape and helped change survival expectations for people with cancer.
“These results build on the benefit of Opdivo and Yervoy in MSI-H/dMMR metastatic colorectal cancer as previously demonstrated in CheckMate -142 and reinforce our commitment to exploring the potential of these therapies to help more patients in need.”
Last month, the company announced plans to discontinue the Phase III RELATIVITY-123 clinical trial of nivolumab plus relatlimab to treat microsatellite stable (MSS) metastatic colorectal cancer (mCRC).