FDA Approves Nivolumab/Ipilimumab Combination in Intermediate- or Poor-Risk Advanced RCC
On April 16, 2018, the U.S. Food and Drug Administration (FDA) granted approvals to nivolumab (Opdivo) and ipilimumab (Yervoy) in combination for the treatment of intermediate- or poor-risk previously untreated advanced renal cell carcinoma (RCC).
CheckMate 214
The approvals were based on CheckMate 214, a randomized open-label trial. Patients with previously untreated advanced RCC received nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for 4 doses followed by nivolumab monotherapy (3 mg/kg) every 2 weeks, or sunitinib (Sutent) at 50 mg daily for 4 weeks followed by 2 weeks off every cycle.
Efficacy was evaluated in intermediate- or poor-risk patients (n = 847). The trial demonstrated statistically significant improvements in overall survival and objective response rate for patients receiving the combination (n = 425) compared with those receiving sunitinib (n = 422). Estimated median overall survival was not estimable in the combination arm compared with 25.9 months in the sunitinib arm (hazard ratio = 0.63, 95% confidence interval [CI] = 0.44–0.89; P < .0001). The objective response rate was 41.6% (95% CI = 36.9%–46.5%) for the combination vs 26.5% (95% CI = 22.4%–31%) in the sunitinib arm (P < .0001). The efficacy of the combination in patients with previously untreated RCC with favorable-risk disease was not established.
The most common adverse reactions (reported in at least 20% of patients treated with the combination) were fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite.
The recommended schedule and dose for this combination is nivolumab at 3 mg/kg followed by ipilimumab at 1 mg/kg, on the same day every 3 weeks for 4 doses, then nivolumab at 240 mg, every 2 weeks or 480 mg every 4 weeks.
Prescribing information for both nivolumab and ipilimumab have been updated with these results. Full prescribing information is available at:
- Nivolumab package insert https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s058lbl.pdf
- Ipilimumab package insert https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s094lbl.pdf
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
