We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Merck's Keytruda Fails in First-Line Bladder Cancer Study
Read MoreHide Full Article
Merck & Co., Inc.’s (MRK - Free Report) 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 - Free Report) , Incyte, Glaxo (GSK - Free Report) and Pfizer (PFE - Free Report) 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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
Image: Shutterstock
Merck's Keytruda Fails in First-Line Bladder Cancer Study
Merck & Co., Inc.’s (MRK - Free Report) 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 - Free Report) , Incyte, Glaxo (GSK - Free Report) and Pfizer (PFE - Free Report) 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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>