Merck (NYSE:MRK) said a combination therapy being developed with partner Eisai failed a late-stage trial testing it as a first-line treatment for a type of cancer in the uterus lining, the two companies said on Friday.
Merck’s Keytruda and Eisai’s Lenvima combination is already approved in the U.S. and other countries to treat certain types of advanced endometrial carcinoma in patients who have received prior systemic therapy.
Friday’s data does not affect the approved indications for the combination or other ongoing trials, Merck said.
At the final analysis, KEYTRUDA plus LENVIMA did not improve OS or PFS sufficiently to meet the study’s prespecified statistical criteria in the first-line treatment of certain patients with advanced or recurrent endometrial carcinoma versus a standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel). The safety profile of KEYTRUDA plus LENVIMA was consistent with that observed in previously reported studies evaluating the combination. A full evaluation of the data from this study is ongoing. The companies will work with investigators to share the results with the scientific community.
“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,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories.
MRK shares fell 22 cents to $103.66.
