Merck & Co., Inc. MRK announced that the pivotal, phase III study — KEYNOTE-590 — evaluating its blockbuster PD-1 inhibitor, Keytruda for the first-line treatment of locally advanced or metastatic esophageal cancer met its co-primary endpoints. The study evaluated the drug in combination with chemotherapy (cisplatin plus 5-fluorouracil) for overall survival (“OS”) and progression-free survival (“PFS”) as co-primary endpoints.
Data from the interim analysis of KEYNOTE-590 study conducted by an independent Data Monitoring Committee showed a statistically significant and clinically meaningful improvement in OS and PFS compared with chemotherapy (cisplatin plus 5-fluorouracil), the current standard of care. The Keytruda combination also achieved significant improvement in objective response rate, the study’s key secondary endpoint.
Esophageal cancer is a difficult-to-treat cancer. It is the seventh most commonly diagnosed cancer and is estimated to be diagnosed in nearly 18,500 adults in the United States and cause more than 16,000 deaths this year.
Currently, Keytruda is approved as monotherapy for the second-line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus in patients whose tumors express PD-L1 in the United States. A potential approval in first-line esophageal cancer will further boost the prospects of Keytruda in this indication. The company will submit results from the study to global regulatory authorities soon.
Merck’s shares have lost 6.5% this year so far against the industry’s 1.8% increase.
Keytruda is a key contributor to Merck’s sales. In a very short span of time, Keytruda has become Merck’s largest product. It is already approved for use in more than 20 indications across several different tumor types in the United States. The drug recorded sales of $6.7 billion in the first half of 2020, up 36.1% year over year. Keytruda sales benefited from strong momentum in the first-line lung cancer indication and launch of Keytruda in multiple 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 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.
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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