Merck & Co Inc (NYSE:MRK) and research partner Eisai said they are halting a late-stage trial that used a combination of drugs to treat a type of head and neck cancer after it didn’t result in an overall survival benefit for patients.
In a statement, the companies said the Phase 3 LEAP 010 trial evaluated Merck’s anti-PD-1 therapy Keytruda together with Eisai’s Lenvima, an orally available multiple receptor tyrosine kinase inhibitor (TKI) for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Following a second analysis of the drug combination conducted by an independent Data Monitoring Committee, they found that Keytruda plus Lenvima did not demonstrate an improvement in overall survival compared to Keytruda plus a placebo, and the likelihood of reaching the protocol-specified threshold for statistical significance for overall survival was evaluated by Merck and Eisai and deemed to be low.
“With the LEAP-010 trial, we aimed to explore whether this combination could improve upon options already available with KEYTRUDA-based regimens for appropriate patients with metastatic or with unresectable, recurrent HNSCC,” commented Merck Research Laboratories’ Dr Gregory Lubiniecki.
“Although the progression-free survival results from this study were encouraging, unfortunately, the combination did not result in an overall survival benefit for patients. We will apply lessons from this trial to help continue advancing research of this combination.”
The companies noted that the combination therapy of Keytruda plus Lenvima is approved in the US, the EU, Japan and other countries for the treatment of advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma.
Merck’s shares were up 0.8% in premarket trading in New York. Eisai’s shares fell 1.2% in Tokyo.
Contact the author at stephen.gunnion@proactiveinvestors.com