The European Commission approved Keytruda and Lenvima to start anti-cancer treatment after a study showed this drug combo gave patients a better chance at overall survival than chemotherapy.
The medication treats advanced and recurrent endometrial cancer, a common cancer affecting the uterus. A first in the European market, the combination of drugs is a product of Merck, a New Jersey company, and Eisai, based in Japan. Merck came up with Keytruda, an anti-PD-1 therapy, while Eisai developed Lenvima, a multiple receptor tyrosine kinase inhibitor available orally.
“Until recently, women in Europe with advanced or recurrent endometrial cancer have faced a difficult prognosis and had few treatment options,” Corina Dutcus, M.D., vice president, Clinical Research, Oncology Business Group at Eisai Inc, said in a press release. “The approval of Keytruda plus Lenvima in this setting reflects the progress that we have made in our collaboration with Merck in developing solutions for those diagnosed with difficult-to-treat cancers. We thank the patients, families and healthcare providers who made this milestone possible.”
The American Cancer Society listed six treatment options for endometrial cancer and included immunotherapy using drugs designed to help the immune system to better kill cancer cells.
“This approval is welcome news for patients in Europe and is based on the first Phase 3 study evaluating an immunotherapy and tyrosine kinase inhibitor combination that showed superior overall survival for patients with advanced or recurrent endometrial cancer compared to chemotherapy,” Dr. Gregory Lubiniecki, vice president, Clinical Research, Merck Research Laboratories, said in a release. “Regardless of mismatch repair status, patients whose endometrial cancer progresses or returns after prior platinum-containing systemic therapies now have a combination treatment option in Keytruda plus Lenvima that demonstrated a 38% reduction in risk of death compared to chemotherapy alone.”
This marks the New Jersey-based company's first combination of immunotherapy with a tyrosine kinase inhibitor approved in Europe related to the condition.
The approval was prompted through an analysis of Phase 3 of the KEYNOTE-775/Study 309 trial.
The acceptance applies to a total of 27 European Union member states, as well as Iceland, Liechtenstein, Norway and Northern Ireland.