Multinational phase 2 trial of first-line pembrolizumab plus lenvatinib for advanced non-clear cell renal cell carcinoma

Immunotherapy-based combinations are standard first-line therapies for clear-cell renal cell carcinoma (RCC). The efficacy of these combinations in non-clear cell (ncc)RCC is not well characterized. The multinational phase 2 KEYNOTE-B61 trial evaluated pembrolizumab plus lenvatinib for previously untreated advanced nccRCC. Confirmed objective response was seen in 49% of patients, including 6% with complete response. The safety profile was consistent with what was seen in previous studies. Median PFS and OS were 17.9 months and not reached, respectively. The authors conclude that results from KEYNOTE-B61 support the use of first-line pembrolizumab plus lenvatinib for advanced nccRCC.