FDA Approves IO Combo for Advanced Renal Cell Cancer

The US Food and Drug Administration (FDA) has approved the immuno-oncology (IO) combination of nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb) as an initial treatment for advanced renal cell carcinoma (RCC) that is of intermediate or poor risk.
The approvals for each drug were based on findings from CheckMate 214, a randomized open-label trial. The trial randomly assigned 1082 patients with previously untreated advanced RCC to receive nivolumab plus ipilimumab followed by nivolumab maintenance therapy or sunitinib (Sutent, Pfizer). Sunitinib is considered standard of care.
The ORR was 41.6% for the combination, vs 26.5% for the sunitinib arm (P < .0001).The median OS was not yet reached in the combination arm; it was 25.9 months in the sunitinib arm (hazard ratio, 0.63; P < .0001). "Based on these results, it means that immunotherapy is not only a new option for these patients, it should become the standard of care."