Merck & Co., Inc. MRK announced that a pivotal phase III study evaluating its PD-1 inhibitor, Keytruda for the second- or third-line treatment of metastatic triple-negative breast cancer (“TNBC”) did not meet its primary endpoints of overall survival (“OS”).
The KEYNOTE-119 study compared Keytruda monotherapy versus chemotherapy in previously-treated metastatic TNBC patients. Data from the study showed that Keytruda did not achieve superiority in OS compared to chemotherapy.
However, the company stated that it will continue with Keytruda’s development in earlier stages, including previously untreated patients of TNBC as well as in combination with chemotherapy in ongoing studies. The drug is not approved for any breast cancer indication.
Merck’s shares lost 0.7% following the disappointing study update. Shares of the company have increased 3.2% so far in 2019 against the industry’s decrease of 1.2%.
Please note that this is the second study failure for Keytruda in 2019. In February, the drug has failed to meet co-primary endpoints of OS and progression free survival in the KEYNOTE-240 study, which evaluated it in advanced hepatocellular carcinoma, the most common type of liver cancer.
Moreover, in April, Keytruda in combination with chemotherapy failed to demonstrate superiority for OS and PFS versus chemotherapy alone in KEYNOTE-062 study, which evaluated the drug in patients with advanced gastric or gastroesophageal junction adenocarcinoma, in first-line setting. However, Keytruda monotherapy demonstrated non-inferiority compared to chemotherapy in similar patients in the study.
Meanwhile, Keytruda has become the top revenue generator for Merck in a short span of time on the back of its several label expansions, especially first-line lung cancer. It is now already approved for use in 15 indications across 10 different tumor types in the United States. The drug generated sales of $2.27 billion in the first quarter of 2019, surging 55% 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, Glaxo GSK and Pfizer PFE 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 approvals worldwide.
Merck & Co., Inc. Price
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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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