Merck & Co Inc (NYSE:MRK) and Eisai announced Friday that their therapeutic combination targeting endometrial cancer as a first-line treatment failed to meaningfully slow the progression of the disease or improve overall survival during a late-stage trial.
The Phase 3 LEAP-001 trial evaluated Merck’s anti-PD-1 therapy Keytruda and Eisai’s orally available multiple receptor tyrosine kinase inhibitor Lenvima as a first-line treatment in patients with endometrial cancer, a disease where cancer cells form in the lining of the uterus.
The therapeutic combination is already approved in the United States, European Union, Japan, and other countries for the treatment of certain types of advanced endometrial carcinoma following prior systemic therapy.
The study found that the therapeutic combination did not meet the study’s prespecified statistical criteria in the first-line treatment of certain patients with advanced or recurrent endometrial carcinoma when compared to a standard of care, platinum-based chemotherapy doublet.
Evaluation of the study from the data is ongoing, the two drugmakers noted.
"We are disappointed that the LEAP-001 trial did not reach its primary endpoints, as we had hoped to bring another potential treatment option to patients when first diagnosed with certain types of advanced or recurrent endometrial carcinoma,” Merck Research Laboratories vice president of global clinical development Dr. Gregory Lubiniecki said in a statement.
“We remain confident in the proven benefit of Keytruda plus Lenvima for the treatment of appropriate patients with certain types of previously treated advanced endometrial carcinoma based on results from the KEYNOTE-775/Study 309 trial and will continue to research the Keytruda plus Lenvima combination in patients with other types of difficult-to-treat cancers.”
Merck shares traded flat at US$103.85 while Eisai’s shares were up 1.8% at US$12.84 shortly before Friday’s opening bell.
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