Merck & Co., Inc.’s MRK phase III study evaluating its blockbuster PD-1 inhibitor, Keytruda for the first line treatment of advanced or metastatic urothelial carcinoma or bladder cancer, failed to meet its co-primary endpoints.
The phase III KEYNOTE-361 compared Keytruda plus chemotherapy (cisplatin or carboplatin plus gemcitabine) to standard-of-care chemotherapy and its two primary endpoints were overall survival (OS) or progression-free survival (PFS).
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.
Merck’s shares have lost 9.6% this year so far compared with the industry’s 1.1% decline.
Keytruda, Merck’s biggest product, is already approved for use in 23 indications across several different tumor types in the United States. For bladder cancer, it is approved for three indications across different types and disease settings. Meanwhile, it is being evaluated as monotherapy and in combination with other anti-cancer therapies for various bladder cancer indications.
Keytruda recorded sales of $3.3 billion in the first quarter of 2020, up 45% year over ear. The drug’s sales were driven by the launch of new indications globally. Keytruda sales, particularly, are benefiting from strong momentum in the first-line lung cancer indication.
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 studied for more than 30 types of cancer in over 1200 studies including 850 plus combination studies. Merck is collaborating with several companies including Amgen AMGN, Incyte, Glaxo GSK and Pfizer PFE separately for the evaluation of Keytruda in combination with other regimens.
Undoubtedly, Keytruda’s solid growth prospects are based on increased utilization, approval for new indications and expectation of additional approvals worldwide. However, such pipeline setbacks don’t bode well for the company.
Merck currently has 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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