Merck and Eisai say two lung-cancer trials failed to meet their main goals

By Ciara Linnane

Combination of Keytruda and Lenvima failed to improve overall survival for patients in trials

Merck and Japanese partner Eisai said Friday that two late-stage trials of a treatment for a certain type of non-small lung cancer failed to meet their primary goals in a disappointing outcome, but said they would continue to push ahead with their research.

The companies said the LEAP-006 and LEAP-008 trials sought to evaluate Merck's Keytruda in combination with Eisai's (JP:4523) (ESAIY) Lenvima versus other options in treating adult patients with metastatic, nonsquamous non-small cell lung cancer (NSCLC).

The primary endpoints were overall survival and progression-free survival, but both trials missed those goals. A full analysis of the data is being conducted and will be shared with the scientific community.

"While these results are not what we hoped for, we are proud of the foundational role that KEYTRUDA has established in the treatment of certain types of lung cancer, and we are committed to continuing to research how we can further improve responses to our medicines for patients with difficult-to-treat forms of the disease," Dr. Gregory Lubiniecki, vice president, global clinical development at Merck Research Laboratories, said in a statement.

Keytruda and Lenvima are approved in the U.S. as a treatment for other cancers, including advanced renal cell carcinoma and certain types of advanced endometrial carcinoma. The partners are studying the combination in other tumor types, including endometrial carcinoma, hepatocellular carcinoma, RCC, head and neck cancer, gastric cancer and esophageal cancer across multiple clinical trials.

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Lung cancer is the leading cause of cancer death worldwide, accounting for more than 2.2 million new cases and 1.8 million deaths in 2020 globally. The most common type in the U.S. is non-small cell lung cancer, which accounts for 81% of all cases.

Merck's stock is down 3.8% in the year to date, while the S&P 500 SPX has gained 12.8%.

-Ciara Linnane

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09-22-23 0731ET

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