FDA Approves First-Line Treatment Combo for Advanced Renal Cell Carcinoma

Officials with the FDA have approved nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co) as a combination treatment for intermediate or poor risk, previously untreated advanced renal cell carcinoma, according to a press release.

The approvals are based on the clinical trial CheckMate 214, which investigated the combination therapy in patients with previously untreated advanced RCC. In the trial, patients received 4 cycles of nivolumab plus low-dose ipilimumab combination, followed by nivolumab maintenance therapy. In the combination arm of the trial, 79% of patients received all 4 doses of the combination and went on to the nivolumab monotherapy phase.

Nivolumab plus low-dose ipilimumab combination is the first and only treatment to show significantly superior survival compared with sunitinib in intermediate- and poor-risk advanced RCC, including a survival benefit regardless of PD-L1 expression, according to the press release.

Currently, only 36% of patients with advanced RCC survive beyond 1 year, and only 8% will survive past 5 years. The approval provides a new treatment option for patients with newly diagnosed advanced RCC across PD-L1 expression levels.

The trial demonstrated statistically significant improvements in overall survival and higher objective response rate (ORR) for patients receiving the combination compared with those receiving sunitinib.

Nivolumab plus ipilimumab reduced the risk of death by 37% compared with sunitinib and was associated with a 41.6% ORR compared with 26.5% for sunitinib. Progression-free survival was 11.6 months for patients who received the combination therapy compared with 8.4 months for those who received sunitinib.

Additionally, the combination therapy was associated with fewer overall Grade 3 or 4 adverse reactions than sunitinib.

The recommended dosing for nivolumab plus ipilimumab is nivolumab 3 mg/kg followed by ipilimumab 1 mg/kg each infused intravenously over 30 minutes on the same day every 3 weeks for 4 doses. After completing 4 doses of the combination, nivolumab should be administered intravenously 240 mg every 2 weeks or 480 mg every 4 weeks over 30 minutes until disease progression or unacceptable toxicity.

Reference

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma [news release]. Bristol-Myers Squibb’s website. https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-opdivo-nivolumab-yerv. Accessed April 16, 2018.