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Merck (MRK) Keytruda Meets Endpoint in Kidney Cancer Study

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Merck & Co., Inc. MRK announced that the pivotal phase III study — KEYNOTE-564 — evaluating Keytruda monotherapy in adjuvant setting in patients with renal cell carcinoma (RCC) or kidney cancer met its primary endpoint of disease-free survival (DFS).

The study evaluated the company’s blockbuster anti-PD-1 therapy in RCC patients as potential adjuvant treatment following nephrectomy (surgical removal of a kidney) or following nephrectomy and resection of metastatic lesions. Data from the interim analysis of the study, conducted by an independent Data Monitoring Committee, showed that Keytruda monotherapy achieved statistically significant and clinically meaningfully improvement in DFS versus placebo. Please note that data from the study may lead to the first monotherapy regimen approval for Keytruda in RCC patients.

Detailed data from the study will be presented at a future medical meeting and will also be submitted to regulatory authorities. Merck is continuing the KEYNOTE-564 study to evaluate the overall survival in RCC patients, a key secondary endpoint of the study.

We note that Keytruda is already approved as first-line treatment for advanced RCC in combination with Pfizer’s PFE Inlyta (axitinib).

Shares of Merck have lost 7.7% so far this year compared with the industry’s decrease of 1.1%.

We note that Keytruda, which is Merck’s major revenue-generating product, is already approved for use in several cancer indications. The drug recorded sales of $14.4 billion in 2020, up 30% year over year. Keytruda sales have been gaining momentum through constant label expansion and the launch of new indications globally.

Last month, the company gained FDA approval for label expansion of Keytruda to include first-line treatment of esophageal and gastroesophageal junction carcinoma. The drug was approved in combination with platinum- and fluoropyrimidine-based chemotherapy. Moreover, a regulatory application seeking another label expansion of Keytruda in first-line treatment of certain bladder cancer patients in Europe received recommendation for approval from the Committee for Medicinal Products for Human Use of the European Medicines Agency in the same month.

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. In fact, the Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 1400 studies, including more than 1000 combination studies.

Merck & Co., Inc. Price

Merck & Co., Inc. Price
Merck & Co., Inc. Price

Merck & Co., Inc. price | Merck & Co., Inc. Quote

Zacks Rank & Stocks to Consider

Merck currently has a Zacks Rank #3 (Hold).

A couple of better-ranked stocks from the biotech sector include Moderna, Inc. MRNA, and Repligen Corporation RGEN, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Moderna’s earnings per share estimates have moved up from $11.45 to $14.96 for 2021 in the past 60 days. The stock has risen 28.1% so far this year.

Repligen’s earnings per share estimates have moved north from $2.03 to $2.23 for 2021 in the past 60 days. The company delivered an earnings surprise of 51.51%, on average, in the last four quarters. The stock has risen 6.5% so far this year.

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