Merck & Co., Inc. (MRK - Free Report) announced that the European Commission has granted approval for label expansion of its PD-L1 therapy Keytruda for use in combination with chemotherapies for first-line metastatic nonsquamous non-small cell lung cancer (“NSCLC”). The drug is approved in combination with Eli Lilly’s (LLY - Free Report) Alimta (pemetrexed) and platinum chemotherapy in adult patients whose tumors have no EGFR or ALK positive mutations.
With this approval, Keytruda has become the first anti-PD-1 therapy to receive approval for treating metastatic NSCLC in first-line setting in combination with chemotherapy in Europe. Notably, the drug is also approved as monotherapy in similar patients with high PD-L1 expression in Europe. The drug is also already approved in the United States for this indication.
The approval was based on data from a pivotal KEYNOTE-189 study, which demonstrated superiority of Keytruda combination regimen in improving overall survival (“OS”) and progression free survival (“PFS”) over chemotherapy. The Keytruda combination significantly improved overall survival, demonstrating a reduction in the risk of death by half (51%) compared to chemotherapy alone. Meanwhile, significant improvement in PFS was observed. The risk of progression or death was reduced by nearly half (48%) for patients in the Keytruda combination arm compared to chemotherapy alone.
So far this year, Merck’s shares have outperformed the industry, rising 23.6% compared with a 4.6% increase for the industry.
Keytruda is a blockbuster drug in Merck’s portfolio and has shown impressive performance since its approval. The drug is the single largest revenue generator for the company with sales of more than $3 billion in the first half of 2018. Merck has been successfully expanding Keytruda’s label over the years, the significant being for the first-line lung cancer indication. It is the only anti-PD-1 approved for treating ling cancer in first-line setting.
The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 800 studies, including more than 400 combination studies. Merck is collaborating with several companies including Amgen (AMGN - Free Report) , Incyte (INCY - Free Report) , Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens. These include several lung cancer studies across multiple settings and stages of the disease, both as a monotherapy as well as a combination therapy.
Several regulatory decisions for new indications in the United States as well as in Europe are pending in the rest of the year and 2019, which if approved can further boost sales.
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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