FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for First-Line Treatment of Advanced Renal Cell Carcinoma

MSD and Eisai today announced that the U.S. FDA has approved the combination of the anti-PD-1 therapy Keytruda and the oral multi-receptor tyrosine kinase inhibitor Lenvima for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). This approval is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which Keytruda plus Lenvima demonstrated statistically significant improvements in the efficacy endpoints of progression-free survival (PFS), overall survival (OS), and confirmed objective response rate (ORR) compared to the active comparator.

Presentation1.png

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 in the active control group. For OS, compared with the active control group, Keytruda plus Lenvima reduced the risk of death by 34% (HR = 0.66; 95% CI, 0.49–0.88; p = 0.0049). Additionally, the confirmed ORR was 71% (95% CI, 66–76; n = 252) in patients receiving Keytruda plus Lenvima versus 36% (95% CI, 31–41; n = 129) in the control group. Keytruda plus Lenvima yielded a complete response (CR) rate of 16% and a partial response (PR) rate of 55%, compared with a CR rate of 4% and a PR rate of 32% in the control group.

“This FDA approval further underscores the potential of Keytruda + Lenvima,” said Gregory Lubiniecki, Ph.D., Vice President, Clinical Research in Oncology, MSD Research Laboratories. “At MSD, we are focused on bringing meaningful innovations to cancer patients to extend their lives. We are proud that our collaboration with Eisai is now helping to improve survival outcomes for patients with advanced renal cell carcinoma, and we remain committed to further exploring the efficacy of Keytruda + Lenvima in other difficult-to-treat cancers.”

About Renal Cell Carcinoma (RCC)

It is estimated that in 2020, there were over 431,000 newly diagnosed cases of kidney cancer worldwide, with more than 179,000 deaths from the disease. Renal cell carcinoma (RCC) is by far the most common type of kidney cancer, accounting for approximately 9 out of every 10 diagnoses. The incidence of RCC in males is approximately twice that in females. Most RCC cases are incidentally detected during imaging studies performed for other abdominal conditions. Approximately 30% of RCC patients present with metastatic disease at diagnosis, and the five-year survival rate for patients diagnosed with metastatic disease is 13%.

References:

[1] FDA Approves KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma (RCC). Retrieved 2021-08-12, from https://www.businesswire.com/news/home/20210811005902/en