Lenvima + Keytruda is approved in Japan for radically unresectable or metastatic renal cell carcinoma.
Eisai and Merck & Co., Inc., announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus Keytruda the anti-PD-1 therapy from Merck & Co., Inc., for radically unresectable or metastatic renal cell carcinoma (RCC).
Lenvima plus Keytruda is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC. This marks the second approval of this combination in Japan; in December 2021, Lenvima plus Keytruda was approved for unresectable, advanced or recurrent endometrial carcinoma that progressed after chemotherapy.
The approval is based on results from the pivotal Phase III CLEAR (Study 307)/KEYNOTE 581 trial, in which Lenvima plus Keytruda demonstrated statistically significant improvements versus sunitinib in the primary efficacy outcome measure of progression-free survival (PFS). Results showed Lenvima plus Keytruda (n=355) 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 (n="357").
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