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Merck (MRK) Keytruda Gets CHMP Nod for First-Line Bladder Cancer

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Zacks Equity Research
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Merck & Co., Inc. MRK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the label expansion of Keytruda in first-line treatment of certain patients with advanced or metastatic urothelial carcinoma or bladder cancer.

The company is seeking label expansion of Keytruda to include data from the phase III KEYNOTE-361 study, which evaluated the drug as monotherapy and in combination with chemotherapy for this indication in Europe. Generally, the EMA follows the CHMP’s recommendation.

Although the KEYNOTE-361 study failed to meet its co-primary endpoints, progression-free survival (PFS) and overall survival (OS), the CHMP concluded that the benefit-risk profile remains positive for Keytruda. Moreover, inclusion of updated data from the KEYNOTE-361 study in the drug’s label will allow evaluation of potential benefit-risk of Keytruda on an individual basis.

The phase III KEYNOTE-361 compared Keytruda plus chemotherapy (cisplatin or carboplatin plus gemcitabine) to standard-of-care chemotherapy. The data showed that in the final analysis though there was an improvement in OS and PFS in the Keytruda arm, the results did not meet statistical significance. As the combination arm of Keytruda did not achieve superiority for the primary endpoints, the monotherapy arm of the study was not tested.

Shares of Merck have lost 5.9% so far this year compared with the industry’s decrease of 0.1%.

We note that Keytruda, which is Merck’s major revenue-generating product, is already approved for use in 26 indications across 16 different tumor types and certain tumor agnostic 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.

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 evaluated in more than 1400 studies including several combination studies. Merck has collaborated with several companies including Amgen AMGN, Incyte, Glaxo GSK and Pfizer PFE, separately, for the evaluation of Keytruda in combination with other regimens.

In a separate press release, Merck announced that it has signed a definitive agreement with privately-held, commercial-stage medical device company, Alydia Health. Per the agreement, Merck’s women’s health business, Organon, will acquire Alydia Healthfor up to $240 million in total consideration. The transaction will occur after the intended spinoff of Organon from Merck, which is expected in the second quarter.

Merck & Co., Inc. Price

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

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

Zacks Rank

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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