Merck & Co., Inc. (MRK - Free Report) announced that a phase III study evaluating its anti-PD-1 therapy, Keytruda as monotherapy for the treatment of high-risk melanoma met the primary endpoint of recurrence-free survival (RFS).
Keytruda is already approved for many types of cancers and treatment settings including lung cancer, melanoma, head and neck cancer, classical Hodgkin’s lymphoma and bladder cancer.
Interim data from the KEYNOTE-054 study showed that treatment with Keytruda, as an adjuvant therapy in surgically resected high-risk melanoma patients, led to significantly improved RFS compared to placebo. In other words, Keytruda showed the potential to extend the duration before the disease recurs in high-risk melanoma patients.
The study will continue to evaluate other key endpoints, including overall survival. Results from the study will be submitted to regulatory authorities and also be presented at a future medical meeting.
Merck is conducting the study in collaboration with The European Organisation for Research and Treatment of Cancer (EORTC).
Shares of Merck have declined 5.4% in the past year against the industry's surge of 16.9%.
Keytruda, the second-largest product in the Merck portfolio, is a key top line driver for Merck. In fact, Keytruda is continuously growing and expanding into new indications and markets globally. The Keytruda development program also significantly advanced in 2017 with several key regulatory approvals, which should further drive sales in 2018.
Keytruda is being studied for more than 30 types of cancer in more than 550 studies, including over 300 combination studies. Merck is collaborating with several companies including Amgen, Inc. (AMGN - Free Report) , Incyte, Glaxo (GSK - Free Report) and Pfizer, Inc. (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens.
In another press release, Merck announced that the FDA has accepted the new drug application (NDA) for its investigational candidate, doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), for the treatment of HIV-1 infection.
Merck is looking to get doravirine approved as a once-daily single tablet in combination with other antiretroviral agents and also as a once-daily fixed-dose combination regimen containing doravirine, lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) (DOR/3TC/TDF). The FDA is expected to give its decision on both the applications on Oct 23, 2018.
Merck 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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