Merck...and Eisai today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for radically unresectable or metastatic renal cell carcinoma (RCC).

Eisai...today announced that the European Commission has approved the combination of LENVIMA (KISPLYX® in the European Union [EU] for the treatment of advanced renal cell carcinoma [RCC])...

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:...Renal Cell Carcinoma (RCC)...in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.

Lenvatinib with pembrolizumab is recommended as an option for untreated advanced renal cell carcinoma in adults, only if: • their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria and • nivolumab with ipilimumab would otherwise be offered and • the companies provide lenvatinib and pembrolizumab according to the commercial arrangements.

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Eisai’s Kisplyx (lenvatinib) combined with Merck’s Keytruda (pembrolizumab) for National Health Service (NHS) use as a treatment option for adult patients with untreated advanced renal cell carcinoma (RCC).

Among all pts, PFS2 was longer with LEN + PEMBRO than with SUN (median not reached vs 28.7 mos; HR, 0.50; 95% CI 0.39–0.65; nominal P<0.0001); PFS2 rates at 24 and 36 mos...LEN + PEMBRO had a statistically significant and clinically meaningful benefit over SUN in the CLEAR study.

Efficacy results for patients in the East Asian subset of the CLEAR trial were consistent with the results of the overall population. The safety profile of LEN + PEMBRO in the East Asian subset was also generally consistent with that of the overall population.

The positive CHMP opinions are based on data from two pivotal Phase 3 trials: CLEAR (Study 307)/KEYNOTE-581 evaluating the combination in adult patients with advanced RCC and KEYNOTE-775/Study 309 evaluating the combination in certain patients with advanced EC....KEYTRUDA plus LENVIMA demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of overall survival (OS)...

Merck...announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for applications seeking two new approvals for the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA...The first set of applications (a supplemental Biologics License Application [sBLA] for KEYTRUDA and a supplemental New Drug Application [sNDA] for LENVIMA) are for the first-line treatment of patients with advanced renal cell carcinoma (RCC), based on progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) data from the pivotal Phase 3 CLEAR study (KEYNOTE-581/Study 307).

ORR was significantly greater with LEN + PEMBRO (ORR 71%; complete response [CR] 16%) vs SUN (ORR 36%; CR 4%; odds ratio 4.35, 95% CI 3.16–5.97)...LEN + PEMBRO demonstrated significant improvements in PFS, OS and ORR vs SUN.

In this phase 3 trial, we randomly assigned (in a 1:1:1 ratio) patients with advanced renal cell carcinoma...Progression-free survival was longer with lenvatinib plus pembrolizumab than with sunitinib (median, 23.9 vs. 9.2 months; hazard ratio for disease progression or death, 0.39; 95% confidence interval [CI], 0.32 to 0.49; P<0.001)...Lenvatinib plus pembrolizumab was associated with significantly longer progression-free survival and overall survival than sunitinib.

This is a protocol-prespecified updated overall survival analysis (data cutoff March 31, 2021) of the open-label, phase 3, randomised CLEAR trial....Efficacy benefits of lenvatinib plus pembrolizumab over sunitinib were durable and clinically meaningful with extended follow-up.