Merck & Co., Inc. MRK announced that a phase III study evaluating its blockbuster PD-L1 inhibitor, Keytruda in patients with relapsed or refractory classical Hodgkin lymphoma (cHL), met one of the dual primary endpoints of progression free survival (PFS),
Interim data from the study (KEYNOTE-204) showed that treatment with Keytruda led to a statistically significant and clinically meaningful improvement in PFS in the above patient population compared to the currently approved therapy, Takeda’s Adcetris (brentuximab vedotin). However, the other dual primary endpoint of overall survival was not formally tested at the interim analysis, which was conducted by an independent Data Monitoring Committee (DMC). The study will continue to test OS and the company plans to file the PFS data with regulatory authorities soon.
Presently, Keytruda is approved for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after three or more prior lines of therapy. This FDA approval was on an accelerated basis and came in March 2017 on the basis of data from the phase II KEYNOTE-087 study. The KEYNOTE-204 study is a confirmatory study for the same indication.
Merck’s shares have declined 10.5% this year so far compared with the industry’s decrease of 9.4%.
Keytruda, Merck’s biggest product, is already approved for use in 23 indications across several different tumor types in the United States.
Keytruda recorded sales of $11 billion in 2019, up 58% year over ear. The drug’s sales were driven by the launch of new indications globally. Keytruda sales, particularly, are benefiting from strong momentum in the first-line lung cancer indication.
The Keytruda development program is also progressing well with Merck spending billions on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in over 1000 studies including 600 plus combination studies. Merck is collaborating with several companies including Amgen AMGN, Incyte, Glaxo GSK and Pfizer PFE separately for the evaluation of Keytruda in combination with other regimens.
Undoubtedly, Keytruda’s solid growth prospects are based on increased utilization, approval for new indications and expectation of additional approvals worldwide.
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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