Merck Gets First Approval in Japan for KEYTRUDA + LENVIMA

Merck (NYSE: MRK) has received first-ever approval from Japanese Ministry of Health, Labour and Welfare (MHLW) for the KEYTRUDA Plus LENVIMA combination.

KEYTRUDA is Merck’s anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells while LENVIMA is the orally available multiple receptor tyrosine kinase inhibitor for the treatment of patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy.  

The approval is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial. The study demonstrated that the combination of KEYTRUDA plus LENVIMA showed statistically significant improvements in overall survival (OS), reducing the risk of death by 38% and progression-free survival (PFS), reducing the risk of disease progression or death by 44% versus chemotherapy.

Management Weighs In

With the current approval, KEYTRUDA plus LENVIMA is now approved in Japan, the U.S. and Europe for certain types of advanced endometrial carcinoma.

Dr. Gregory Lubiniecki, Vice President of  Clinical Research, Merck Research Laboratories  commented, “Rates of endometrial carcinoma have been steadily increasing in Japan each year, and there are limited options for patients who are diagnosed at an advanced stage or find their disease has returned.”

He further added, “With today’s approval, patients in Japan with unresectable, advanced or recurrent endometrial carcinoma now have the option of the first immunotherapy and tyrosine kinase inhibitor combination that has significantly improved overall survival and progression-free survival compared to chemotherapy.”

Analysts Recommendation

On December 23, Mizuho Securities analyst Mara Goldstein reiterated a Buy rating on the stock with a price target of $100 (32.1% upside potential)

According to Analysts Ratings, the stock has a Moderate Buy based on 8 Buys and 9 Holds. The average Merck stock price forecast of $90.31 implies the stock has upside potential of 19.3% from current levels.

Bloggers Weigh In

TipRanks data shows that financial blogger opinions are 94% Bullish on MRK stock, compared to a sector average of 69%.

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