Merck, Eisai: Keytruda/Lenvima Combo Fails in Two Non-Small Cell Lung Cancer Studies

By Colin Kellaher

A pair of late-stage studies of a cancer-drug combination from Merck & Co. and Eisai missed their main goals in patients with certain types of metastatic non-small cell lung cancer, or NSCLC.

The companies said Friday that a study evaluating the addition of Lenvima, which they are jointly developing, to the currently approved combination of Merck's Keytruda, Eli Lilly's Alimta and platinum-containing chemotherapy, didn't meet its dual primary endpoints of overall survival and progression-free survival as a first-line treatment for adults with metastatic, nonsquamous NSCLC who have confirmation that epidermal growth factor receptor, anaplastic lymphoma or c-ros oncogene 1 directed therapies aren't indicated.

The second study, which evaluated Keytruda plus Lenvima versus docetaxel in patients with metastatic NSCLC who progressed on or after platinum-containing chemotherapy and one prior anti-PD-1/-L1 immunotherapy, and have confirmation that the same directed therapies aren't indicated, also missed the dual primary endpoints of overall survival and progression-free survival.

Lung cancer is the leading cause of cancer death around the world, with non-small cell lung cancer accounting for more than 80% of all cases.

Merck, based in Rahway, N.J., and Tokyo-based Eisai said the safety profile of Keytruda plus Lenvima in the studies was consistent with previously reported data on the combination.

Eisai and Merck formed a collaboration in 2018 to jointly develop, manufacture and commercialize Lenvima as monotherapy and in combination with Merck's blockbuster cancer drug Keytruda.

The combination is approved in the U.S., the EU, Japan and other countries for the treatment of advanced renal cell carcinoma and certain types of advanced endometrial carcinoma, and the companies are studying it in multiple tumor types.

Merck and Eisai said the results from the failed studies don't affect the current approved indications or other ongoing trials for the combination.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 22, 2023 07:31 ET (11:31 GMT)

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