Merck & Co., Inc, (MRK - Free Report) announced that a pivotal phase III study evaluating its PD-1 inhibitor, Keytruda for the second-line treatment of advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, did not meet its co-primary endpoints of overall survival (OS) and progression-free survival (PFS).
The KEYNOTE-240 study compared Keytruda plus best supportive care versus placebo plus best supportive care to treat advanced HCC patients who were previously treated with systemic therapy. Though the study did show an improvement in OS and PFS in the Keytruda arm compared to placebo, the results were not statistically significant.
Keytruda is presently approved for the treatment of patients with HCC who have been previously treated with Bayer (BAYRY - Free Report) /Amgen’s (AMGN - Free Report) Nexavar (sorafenib). This approval was based on data from KEYNOTE-224 study. Had the data from the KEYNOTE-240 study been positive and eventually approved to be added to Keytruda’s label, it would have expanded the drug’s eligible patient population.
Keytruda is being evaluated in several other studies as monotherapy in second-line HCC including KEYNOTE-394 phase III study.
In a separate press release, Merck announced that the FDA has granted approval to Keytruda to be used as an adjuvant therapy for the treatment of patients with high-risk stage III melanoma.
The drug is already approved in the United States as a monotherapy for the treatment of adult patients with advanced melanoma. The approval in the adjuvant setting will help Merck gain access to a broader melanoma patient population in the United States. This is the first approval in United States for Keytruda in the adjuvant setting. It was approved for adjuvant melanoma in the EU in December last year.
The FDA approval was based on data from the pivotal phase III KEYNOTE-054 study, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC). Data from the study showed that treatment with Keytruda led to a significant reduction in the risk of cancer returning after surgery. Melanoma patients often have a high risk of disease recurrence.
Merck’s stock rose 45.3% in the past year compared with a 7.8% increase for the industry.
Merck’s outperformance in the past year can largely be attributed to strong performance and positive regulatory updates related to Keytruda. In a very short span of time, Keytruda has become Merck’s largest product. It is now already approved for use in 15 indications across 10 different tumor types in the United States. The drug generated sales of $7.17 billion in 2018, reflecting a massive 88% surge year over year. Keytruda is continuously growing and expanding into new indications and markets globally.
The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 900 studies, including more than 500 combination studies. Merck is collaborating with several companies including Amgen, Incyte (INCY - Free Report) , Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
We believe that Keytruda has strong growth prospects based on increased utilization, recent approvals for new indications and potential 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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