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 (MRK) Keytruda for Liver Cancer to Undergo FDA Review
Read MoreHide Full Article
Merck (MRK - Free Report) announced that the FDA has accepted its supplemental biologics license application for blockbuster drug Keytruda for review in combination with standard-of-care chemotherapy (gemcitabine and cisplatin) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Keytruda, Merck’s blockbuster oncology drug, is an anti-PD-1 therapy. A decision from the regulatory body is expected on Feb 7, 2024.
The FDA’s acceptance of the sNDA is based on data from Merck’s KEYNOTE-966 study of Keytruda plus Chemotherapy for the above-stated indication. The primary endpoint of the phase III KEYNOTE-966 study is overall survival (OS). Secondary endpoints of the study include progression-free survival, objective response rate and duration of response and safety.
In the year so far, shares of Merck have lost 0.6% compared with the industry’s 0.5% decline.
Image Source: Zacks Investment Research
Merck reported top-line results from the study in January 2023, in which a statistically significant and clinically meaningful improvement in OS versus chemotherapy alone for the first-line treatment of patients with advanced or unresectable BTC was observed.
Detailed results from the KEYNOTE-966 study announced in April 2023 showed that the Keytruda/chemotherapy combo reduced the risk of death by 17% compared with chemotherapy alone in patients at 25.6 months. The study also met its corresponding secondary endpoints but statistical significance was not achieved in the same.
The safety profile of Keytruda in the KEYNOTE-966 study was found to be coherent with that observed in previously reported studies and no new safety concerns were identified in the course of the study.
Biliary tract cancer is a group of rare and highly aggressive cancers in the gallbladder and bile ducts. Per Merck, about 20,000 patients, mostly between the age of 50 and 70, are diagnosed with BTC in the United States each year. Of these patients, 70% of BTC patients are diagnosed at an advanced stage, facing a very poor survival prognosis.
Merck is simultaneously evaluating Keytruda in several other gastrointestinal cancer indications, including a KEYNOTE-937 study in earlier-stage hepatocellular carcinoma, in combination with Eisai’s Lenvima(lenvatinib) for first-line treatment of patients with advanced renal cell carcinoma and in the LEAP-012 study for transarterial chemoembolization.
Keytruda is currently approved for several types of cancer, accounting alone for around 40% of Merck’s pharmaceutical sales in the last reported quarter. Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally.
Merck continues to evaluate Keytruda in several label-expanding studies in hepatobiliary, esophageal, pancreatic, colorectal and gastric cancers.
Some better-ranked stocks in the overall medical sector are Novo Nordisk (NVO - Free Report) , Novartis (NVS - Free Report) and Adaptimmune Therapeutics . While Novo Nordisk sports a Zacks Rank #1 (Strong Buy), Novartis and Adaptimmune both carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, the Zacks Consensus Estimate for Novo Nordisk’s 2023 earnings per share has increased from $4.43 to $5.07. During the same period, the estimate for Novo Nordisk’s 2024 earnings has increased from $5.19 to $5.91. In the year so far, shares of Novo Nordisk have gained by 17.8%.
NVO beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average earnings surprise of 0.35%.
In the past 90 days, the Zacks Consensus Estimate for Novartis’ 2023 earnings per share has increased from $6.55 to $6.72. During the same period, the estimate for Novartis’ 2024 earnings has increased from $7.04 to $7.26. In the year so far, shares of Novartis have gained by 10.9%.
NVS beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 5.15%.
In the past 90 days, the Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has remained stable at 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 74 cents to 56 cents. In the year so far, shares of Adaptimmune Therapeutics have fallen by 30.8%.
ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Merck's (MRK) Keytruda for Liver Cancer to Undergo FDA Review
Merck (MRK - Free Report) announced that the FDA has accepted its supplemental biologics license application for blockbuster drug Keytruda for review in combination with standard-of-care chemotherapy (gemcitabine and cisplatin) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Keytruda, Merck’s blockbuster oncology drug, is an anti-PD-1 therapy. A decision from the regulatory body is expected on Feb 7, 2024.
The FDA’s acceptance of the sNDA is based on data from Merck’s KEYNOTE-966 study of Keytruda plus Chemotherapy for the above-stated indication. The primary endpoint of the phase III KEYNOTE-966 study is overall survival (OS). Secondary endpoints of the study include progression-free survival, objective response rate and duration of response and safety.
In the year so far, shares of Merck have lost 0.6% compared with the industry’s 0.5% decline.
Image Source: Zacks Investment Research
Merck reported top-line results from the study in January 2023, in which a statistically significant and clinically meaningful improvement in OS versus chemotherapy alone for the first-line treatment of patients with advanced or unresectable BTC was observed.
Detailed results from the KEYNOTE-966 study announced in April 2023 showed that the Keytruda/chemotherapy combo reduced the risk of death by 17% compared with chemotherapy alone in patients at 25.6 months. The study also met its corresponding secondary endpoints but statistical significance was not achieved in the same.
The safety profile of Keytruda in the KEYNOTE-966 study was found to be coherent with that observed in previously reported studies and no new safety concerns were identified in the course of the study.
Biliary tract cancer is a group of rare and highly aggressive cancers in the gallbladder and bile ducts. Per Merck, about 20,000 patients, mostly between the age of 50 and 70, are diagnosed with BTC in the United States each year. Of these patients, 70% of BTC patients are diagnosed at an advanced stage, facing a very poor survival prognosis.
Merck is simultaneously evaluating Keytruda in several other gastrointestinal cancer indications, including a KEYNOTE-937 study in earlier-stage hepatocellular carcinoma, in combination with Eisai’s Lenvima(lenvatinib) for first-line treatment of patients with advanced renal cell carcinoma and in the LEAP-012 study for transarterial chemoembolization.
Keytruda is currently approved for several types of cancer, accounting alone for around 40% of Merck’s pharmaceutical sales in the last reported quarter. Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally.
Merck continues to evaluate Keytruda in several label-expanding studies in hepatobiliary, esophageal, pancreatic, colorectal and gastric cancers.
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
Zacks Rank and Stocks to Consider
Merck currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall medical sector are Novo Nordisk (NVO - Free Report) , Novartis (NVS - Free Report) and Adaptimmune Therapeutics . While Novo Nordisk sports a Zacks Rank #1 (Strong Buy), Novartis and Adaptimmune both carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, the Zacks Consensus Estimate for Novo Nordisk’s 2023 earnings per share has increased from $4.43 to $5.07. During the same period, the estimate for Novo Nordisk’s 2024 earnings has increased from $5.19 to $5.91. In the year so far, shares of Novo Nordisk have gained by 17.8%.
NVO beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average earnings surprise of 0.35%.
In the past 90 days, the Zacks Consensus Estimate for Novartis’ 2023 earnings per share has increased from $6.55 to $6.72. During the same period, the estimate for Novartis’ 2024 earnings has increased from $7.04 to $7.26. In the year so far, shares of Novartis have gained by 10.9%.
NVS beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 5.15%.
In the past 90 days, the Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has remained stable at 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 74 cents to 56 cents. In the year so far, shares of Adaptimmune Therapeutics have fallen by 30.8%.
ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.