The combination therapy reduced the risk of death by 37% versus standard of care, sunitinib, in intermediate- and poor-risk patients.
Bristol-Myers Squibb (BMS) has announced results from the Phase III CheckMate -214 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC), including data on key subgroups.
With a minimum follow-up of 17.5 months, Opdivo in combination with Yervoy reduced the risk of death 37% 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.
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% compared with sunitinib. The median OS had not yet been reached for the combination and was 32.9 months for sunitinib.
Results for objective response rate (ORR) and progression-free survival (PFS) in intermediate- and poor-risk patients, the two other co-primary endpoints, were previously reported. The safety of the combination was consistent with that observed in previously reported studies of these medicines in patients with RCC.
“There is an unmet need for additional treatment options in the first line setting that may provide a meaningful survival benefit including more durable, complete responses for patients with advanced RCC. These results for the combination of nivolumab and ipilimumab are very encouraging in patients with first-line mRCC who have a very poor prognosis,” said Bernard Escudier, former chair of the genitourinary group of the Institut Gustave Roussy in Villejuif, France.
“As the pioneer in immuno-oncology research, we set a goal of increasing overall survival for more patients by combining agents and have now, for the second time in a Phase III trial, demonstrated that the Opdivo plus Yervoy combination may provide a survival advantage for patients,” said Vicki Goodman, head of new asset development, BMS. “These positive data showing the Opdivo plus Yervoy combination improved survival in the first-line setting offer the potential, pending regulatory approval, to change the standard of care in the first-line treatment of advanced RCC and may represent a significant step forward for patients with this disease.”Read More