Merck ( MRK Quick Quote 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.
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 Quick Quote NVO - Free Report) , Novartis ( NVS Quick Quote NVS - Free Report) and Adaptimmune Therapeutics ( ADAP Quick Quote ADAP - Free Report) . 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.
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