12 September 2017 - - New York, New York-based biopharmaceutical company Bristol-Myers Squibb (NYSE: BMY) has provided results from the Phase 3 CheckMate -214 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma, including data on key subgroups, the company said.
With a minimum follow-up of 17.5 months, Opdivo in combination with Yervoy reduced the risk of death 37% [HR 0.63; 99.8% CI: 0.44 to 0.89; P < 0.0001] compared with sunitinib, the current standard of care, in an interim analysis of overall survival (OS) in intermediate- and poor-risk patients, the co-primary endpoint. The median OS had not yet been reached for the combination and was 26 months for sunitinib (95% CI:22.1 to NA).
The Opdivo plus Yervoy combination also improved OS in all randomized patients, a secondary endpoint. In this population, the combination reduced the risk of death 32% [HR 0.68; 99.8% CI: 0.49 to 0.95; P=0.0003] compared with sunitinib.
The median OS had not yet been reached for the combination and was 32.9 months for sunitinib (95% CI: NA to NA).
Adverse events leading to discontinuation were reported in 22% of patients in the combination group, compared with 12% of patients in the sunitinib group.
In the CheckMate -214 trial, patients in the combination group received Opdivo3 mg/kg plus Yervoy 1 mg/kg every 3 weeks for 4 doses followed by Opdivo 3 mg/kg every 2 weeks. Patients in the comparator group received sunitinib 50 mg once daily for 4 weeks, followed by 2 weeks off before continuation of treatment. Patients were treated until progression or unacceptable toxic effects.
Opdivo is a programmed death-1 immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response, and to fight cancer.
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, and distributes biopharmaceutical products worldwide.
The company offers chemically-synthesised drug and biologic in various therapeutic areas, such as oncology; cardiovascular; immunoscience; and virology comprising human immunodeficiency virus infection (HIV).