Merck and Co., Inc. (MRK - Free Report) gained priority review for yet another supplemental biologics license application (sBLA) for its PD-1 inhibitor, Keytruda. With the latest application, Merck is looking to get Keytruda approved in combination with chemotherapy for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC), which is a difficult-to-treat lung cancer patient population. The FDA granted priority review to this sBLA with a decision scheduled on Oct 30.
The sBLA filing was based on data from the KEYNOTE-407 study. At the recently concluded annual meeting of the American Society of Clinical Oncology, data presentation from this pivotal lung cancer study resulted in Merck emerging as a winner at this annual key cancer event. Data from the study showed that the combination of Keytruda plus chemotherapy led to significant improvement in both overall survival (OS) and progression-free survival regardless of PD-L1 expression. PD-L1 is a protein present on the surface of cells.
The risk of death (OS) was reduced by 36% compared to chemotherapy alone. The PFS improvement or as we say reduction in the risk of progression or death was nearly half for patients in the Keytruda combination group compared with chemotherapy alone.
The data was termed “practice changing” by CNBC – changing the way doctors look at prescribing these drugs to cancer patients. It further cemented Merck’s position in the lung cancer market, which is the most lucrative oncology sector.
This year so far, Merck’s shares have risen 7.4% against the industry’s decline of 5.1%.
In a short span of time, Keytruda has become Merck’s largest product. It is already approved for use in 10 different settings involving seven different tumor types. This year, it has already gained approval for two new indications. These include third-line treatment of adult as well as pediatric patients with primary mediastinal B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma and second-line treatment of recurrent or metastatic cervical cancer. These label expansion approvals should drive sales of Keytruda in the future quarters.
The treatment generated sales of $1.5 billion in first-quarter 2018, up 12.9% sequentially and 151% year over year. This upside was driven by the global launch for new indications, which further boosted demand. Keytruda sales are gaining, particularly from strong momentum in the first-line lung cancer indication. In fact, Keytruda is the only anti-PD-1 approved in the first-line setting for certain lung cancer patients both as a monotherapy as well as a combination therapy with Eli Lilly’s (LLY - Free Report) cancer drug, Alimta (pemetrexed) and carboplatin (pem/carbo).
Keytruda is also 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 (INCY - Free Report) , Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
Merck 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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