Merck (MRK - Free Report) announced that its pivotal study – KEYNOTE-407 – evaluating Keytruda-chemotherapy combination in first-line metastatic squamous non-small cell lung cancer (“NSCLC”) met its dual primary endpoint of overall survival (“OS”) and progression free survival (“PFS”). The drug in combination with chemotherapy demonstrated significantly longer OS and PFS versus chemotherapy alone.
Merck’s supplemental Biologics License Application (“sBLA”) seeking continued approval of Keytruda combined with Eli Lilly’s (LLY - Free Report) Alimta and platinum chemotherapy for treating metastatic non-squamous NSCLC is under review in the United States. The sBLA was filed based on encouraging data from another phase III study, KEYNOTE-189.
The company plans to share data from the KEYNOTE-407 study with FDA and may expand the sBLA to include patients with squamous histology.
The company will present detailed data from the KEYNOTE-407 study at the upcoming annual meeting of the American Society of Clinical Oncology next month.
Shares of Merck were up 0.2% in after-market trading after the news was announced. This year so far, Merck’s shares have outperformed the industry. Its shares have risen 5.1% in the period against the industry’s decline of 4%.
Notably, Keytruda is already approved as monotherapy for the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 protein levels of 50% or greater. Keytruda also has accelerated approval to treat first-line patients with metastatic NSCLC in combination with Alimta and chemotherapy.
Merck remains focused on developing Keytruda as monotherapy or combination therapy for the treatment of lung cancer with various mutation or histology in first-line setting in a bid to further reinforce its position in that segment. Lung cancer is an attractive market as it is the largest cause of death among all cancer patients.
Moreover, Keytruda is the only immune-oncology drug, which is approved for the treatment of lung cancer in the first-line setting. We remind investors that Bristol-Myers (BMY - Free Report) is also developing its immune-oncology drug, Opdivo, in first-line lung cancer. However, Keytruda’s early entry and positive data readouts from several phase III studies in expanded first-line lung cancer patients bode well for the company’s top line.
We note that Keytruda is marketed for many types of cancer and treatment settings including lung cancer, melanoma, head and neck cancer, classical Hodgkin’s lymphoma, gastric cancer, bladder cancer and microsatellite instability-high (MSI-H) or mismatch repair deficient cancer.
Meanwhile, Keytruda is being studied for more than 30 types of cancer, in more than 700 studies, including in excess of 400 combination studies. Merck is collaborating with several companies including Amgen (AMGN - Free Report) , Incyte, Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
Merck currently carries 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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