Merck & Co., Inc. MRK announced that its blockbuster drug, Keytruda, in combination with Lenvima, received accelerated approval from the FDA as a treatment for advanced endometrial carcinoma.
Women with advanced endometrial carcinoma in whom the disease is not microsatellite instability-high or mismatch repair deficient and has progressed after prior systemic therapy, and women ineligible for curative surgery or radiation are eligible for treatment with this combination therapy. Please note that this is the first approval for a combination regimen of Keytruda and Lenvima for any indication in the United States.
Please note that,in March 2018, Merck formed a deal with Japan’s Eisai to co-develop and commercialize the latter’s tyrosine kinase inhibitor, Lenvima, both as a monotherapy as well as in combination with Keytruda, for several types of cancer.
So far this year, Merck’s shares have outperformed the industry, rising 8% against 2.4% decrease for the industry.
Please note that the approval of Keytruda+Lenvima was based on tumor response rate and durability of response (“DOR”) achieved in the phase II study — KEYNOTE-146 — evaluating the combination regimen in metastatic endometrial carcinoma patients whose disease has progressed following at least one prior systemic therapy in any setting. The combination regimen achieved an objective response rate of 38.3% with complete response rate of 10.6%. It achieved DOR of more than six months in 69% of patients treated.
Continued approval of the regimen remains contingent on data from confirmatory study.
We note that the combination regimen has resulted in fatal adverse events in 3% of the patients while serious adverse events occurred in 52% of the patients. These events led to discontinuation of treatment with the combination regimen in 19% of the patients.
Meanwhile, Merck is developing Keytruda for more than 30 types of cancer in more than 1000 studies, including more than 600 combination studies. Merck has collaborated with several companies including Amgen AMGN, Incyte INCY, Glaxo and Pfizer PFE separately for the evaluation of Keytruda in combination with other regimens.
In a separate press release, Merck announced that the FDA has accepted its biologics license application seeking approval for its Ebola vaccine, V920, for the prevention of disease caused by the Ebola Zaire virus. The application was granted priority review and a decision from the FDA is expected by Mar 14, 2020. The vaccine is also under review in Europe and submissions to the World Health Organization ("WHO") to achieve prequalification status have been completed. Merck has already shipped many doses of this investigational vaccine to the WHO to prevent outbreak of Ebola, especially in African regions.
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Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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