publication date: Nov. 13, 2020

Clinical Roundup

Keytruda + Lenvima meet PFS primary endpoint in advanced RCC

In a phase III trial, Keytruda (pembrolizumab) plus Lenvima (lenvatinib) met the primary endpoint of progression-free survival as first-line treatment of advanced renal cell carcinoma.

The phase III KEYNOTE-581/CLEAR trial also met key secondary endpoints of overall survival and objective response rate, demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat study population.

Keytruda is sponsored by Merck, and Lenvima is sponsored by Eisai. The trial evaluated combinations of Keytruda plus Lenvima, and Lenvima plus everolimus were evaluated versus sunitinib for the first-line treatment of patients with advanced RCC.

The ITT population included patients across all Memorial Sloan Kettering Cancer Center risk groups (favorable, intermediate and poor). The safety profiles of both Keytruda plus Lenvima and Lenvima plus everolimus were consistent with previously reported studies.

“The results from KEYNOTE-581/CLEAR (Study 307) support the potential use of Keytruda plus Lenvima for the first-line treatment of advanced RCC. These data also support the potential first-line use of Lenvima plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy,” Takashi Owa, vice president and chief medicine creation and chief discovery officer in the Oncology Business Group at Eisai, said in a statement.

Merck and Eisai are continuing to study the Keytruda plus Lenvima combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program across 19 trials in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, RCC, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer).

Continue reading Keytruda + Lenvima meet PFS primary endpoint in advanced RCC
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