KENILWORTH (NJ) (dpa-AFX) - The European Commission 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 the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation, Merck (MRK) and Eisai said in a statement.
The approval marks the first combination of an immunotherapy with a tyrosine kinase inhibitor approved in Europe for these patients with advanced or recurrent endometrial carcinoma.
The approval was based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival, reducing the risk of death by 38%, and progression-free survival, reducing the risk of disease progression or death by 44%, versus chemotherapy.
In a separate press release, Merck and Eisai said that the European Commission has approved the combination of KEYTRUDA, plus LENVIMA for the first-line treatment of adult patients with advanced renal cell carcinoma or RCC.
The approval for advanced RCC is based on results from the pivotal Phase 3 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, reducing the risk of disease progression or death by 61% with a median PFS of 23.9 months versus 9.2 months for sunitinib, and overall survival, reducing the risk of death by 34% versus sunitinib.
The approval allows marketing of KEYTRUDA plus LENVIMA in all 27 EU member states plus Iceland, Liechtenstein, Norway and Northern Ireland.
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