(HealthDay News) — For first-line treatment of advanced renal cell carcinoma, progression-free and overall survival are significantly longer with lenvatinib plus pembrolizumab versus sunitinib, according to a study published online in the New England Journal of Medicine to coincide with the American Society of Clinical Oncology annual Genitourinary Cancers Symposium.

Robert Motzer, MD, from the Memorial Sloan Kettering Cancer Center in New York City, and colleagues randomly assigned patients with advanced renal cell carcinoma and no previous systemic therapy to receive lenvatinib plus pembrolizumab, lenvatinib plus everolimus, or sunitinib in a 1:1:1 ratio (355, 357, and 357 patients, respectively).

The researchers found that progression-free survival was longer with lenvatinib plus pembrolizumab and with lenvatinib plus everolimus than with sunitinib (median, 23.9 and 14.7 months, respectively, versus 9.2 months; hazard ratio for progression or death, 0.39 [95% confidence interval, 0.32 to 0.49; P<.001] and 0.65 [95% confidence interval, 0.53 to 0.80; P<0.001], respectively). Longer overall survival was seen for lenvatinib plus pembrolizumab versus sunitinib (hazard ratio for death, 0.66; 95% confidence interval, 0.49 to 0.88; P=.005), but not for lenvatinib plus everolimus versus sunitinib (hazard ratio, 1.15; 95% confidence interval, 0.88 to 1.50; P=.30). During treatment, grade 3 or higher adverse events emerged or worsened in 82.4%, 83.1%, and 71.8% of those receiving lenvatinib plus pembrolizumab, lenvatinib plus everolimus, or sunitinib, respectively.

Continue Reading

“This trial is a step forward in that it provides data that will assist in determining which combination of anti–PD-1 drug and VEGFR tyrosine kinase inhibitor may be effective as an alternative to nivolumab and ipilimumab for some patients,” write the authors of an accompanying editorial.

Several authors disclosed financial ties to pharmaceutical companies, including Eisai and Merck Sharp and Dohme, which partially funded the study.


Motzer R, Alekseev B, Rha S-Y, et al. Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. N Engl J Med.

Ravaud A. A step ahead in metastatic renal cell carcinoma. N Engl J Med.