FDA approves Keytruda + Lenvima combination for first-line treatment of adult patients with advanced renal cell carcinoma

The approval is based on results from the pivotal Phase III CLEAR (Study 307)/KEYNOTE-581 trial, in which Keytruda plus Lenvima demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival (PFS), overall survival (OS) and confirmed objective response rate (ORR).

For PFS, Keytruda plus Lenvima reduced the risk of disease progression or death by 61% (HR=0.39 [95% CI: 0.32-0.49]; p<0.0001) with a median pfs of 23.9 months versus 9.2 months for sunitinib. for os, keytruda plus lenvima reduced the risk of death by 34% (hr="0.66" [95% ci: 0.49-0.88]; p="0.0049)" versus sunitinib. additionally, the confirmed orr was 71% (95% ci: 66-76) (n="252)" for patients who received keytruda plus lenvima versus 36% with sunitinib (95% ci: 31-41) (n="129)." keytruda plus lenvima achieved a complete response (cr) rate of 16% and partial response (pr) rate of 55% versus a cr rate of 4% and a pr rate of 32% for those who received sunitinib.></0.0001)>

“This approval is based in part on data demonstrating that Keytruda plus Lenvima significantly reduced the risk of disease progression or death versus sunitinib,” said Dr. Robert Motzer, Jack and Dorothy Byrne Chair in Clinical Oncology, Kidney Cancer Section Head, Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center. “This is a significant milestone for newly diagnosed patients with advanced renal cell carcinoma and introduces a promising combination option in the first-line setting.”

This approval was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to improve the efficiency of the review process for applications to ensure that treatments are available to patients as early as possible..