Opdivo, Yervoy Combination Study Meets Co-Primary Endpoint

Bristol-Myers Squibb announced Part 1a of the Phase 3 CheckMate -227 trial evaluating Opdivo® (nivolumab) plus low-dose Yervoy® (ipilimumab) met the co-primary endpoint of overall survival (OS), demonstrating a superior benefit versus chemotherapy in first-line non-small cell lung cancer (NSCLC) patients whose tumors express PD-L1 ≥1%. The safety profile was consistent with previously reported findings in first-line NSCLC for the Opdivo 3 mg/kg every two weeks and low-dose Yervoy (1 mg/kg) every six weeks combination schedule. The company will share data from this trial with regulatory authorities.

In an exploratory analysis of patients in Part 1b whose tumors do not express PD-L1, a survival benefit was also observed with Opdivo plus low-dose Yervoy.

"CheckMate-227 is the first Phase 3 trial to demonstrate that patients with lung cancer can achieve superior overall survival with a dual immunotherapy combination versus chemotherapy," said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. "Lung cancer is the third tumor type where the Opdivo plus Yervoy regimen has shown a significant overall survival benefit in a randomized Phase 3 trial, reinforcing the importance of Yervoy in the treatment of cancer. We thank the patients and investigators who participated in this trial."

"The nivolumab plus ipilimumab results from Part 1a of CheckMate-227 offers the potential for a chemo-sparing regimen that demonstrates an OS benefit to first-line lung cancer patients," said Martin Reck, CheckMate 227 study investigator, from Lung Clinic Grosshansdorf, German Center of Lung Research. "I am also encouraged to see activity in PD-L1 expressors and non-expressors, and look forward to seeing the full data presented in the future."

Bristol-Myers Squibb also announced today that Part 2 of the CheckMate -227 trial, evaluating Opdivo plus chemotherapy, did not meet the pre-specified primary endpoint of OS versus chemotherapy in patients with non-squamous histology, regardless of PD-L1 status.

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