FDA Approvals : Episode 3


FDA Approval of Frontline Nivolumab/Ipilimumab Combo in RCC

Hello and welcome to OncLive News Network, Breaking News. I'm Gina Columbus.

The FDA has approved the PD-1/CTLA-4 inhibitor combination of nivolumab (Opdivo) and ipilimumab (Yervoy) as a frontline treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma.

The approval is based on the results of the phase III CheckMate-214 trial, in which first-line treatment with nivolumab plus ipilimumab reduced the risk of death by 37% compared with sunitinib for patients with mRCC.

In the randomized study, the median overall survival (OS) was not reached with the combination versus 32.9 months with sunitinib. In those specifically with intermediate- and poor-risk RCC, the median OS was not reached in the nivolumab and ipilimumab arm and was 26.0 months in the sunitinib arm. This was found to be a 37% reduction in the risk of death. There was not a benefit for the combination versus sunitinib in those with favorable risk disease.

Across the full study, the confirmed overall response rate was 39% and 32% in the nivolumab/ipilimumab group and sunitinib group, respectively. Nine percent of patients in the nivolumab/ipilimumab group had a complete response (CR) and 32% had a partial response (PR), versus 1% CR and 25% PR respectively, in the sunitinib group.

For more breaking news, subscribe to email alerts from OncLive.com. Thank you for watching! I'm Gina Columbus.

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