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Merck Gets Priority Review for Yet Another Keytruda sBLA

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Merck & Co., Inc. MRK announced that the FDA has granted priority review to yet another supplemental biologics license application (sBLA) for its PD-L1 inhibitor, Keytruda. In the latest sBLA, Merck is looking for FDA’s approval to get overall survival (OS) data from a pivotal lung cancer study — KEYNOTE-042 study — included on the label of Keytruda. With the FDA granting priority review, a decision is expected on Jan 11, 2019.

The KEYNOTE-042 study was conducted to evaluate Keytruda as a first-line treatment option for patients with locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) whose tumors express PD-L1 protein levels of 1 percent or greater (TPS of ≥1 percent).

So far this year, Merck’s shares have outperformed the industry, rising 24.1% compared with a 5% increase for the industry.


In April, Merck had said that in such patients, Keytruda led to a significant survival benefit compared with platinum-based chemotherapy. At the American Society of Clinical Oncology (ASCO) meeting in June, Merck presented additional data from the study. The data demonstrated that in NSCLC patients with TPS of ≥1 percent, median overall survival (OS) was 16.7 months in the Keytruda arm versus 12.1 months in the chemotherapy arm.

In the PD-L1 TPS ≥50 percent patient population, median OS was 20 months while that in patients with TPS of ≥20 percent was 17.7 months versus 12.2 months and 13 months, respectively for chemotherapy alone.

Notably, Keytruda monotherapy is already marketed for the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 protein levels of 50 percent or greater (TPS of ≥50 percent) based on data from the KEYNOTE-024 study.

If the OS data from KEYNOTE-042 study are approved to be included in Keytruda’s label, the drug can be prescribed to treat an expanded lung cancer patient population, further reinforcing its position in the lung cancer market.

Keytruda is a key contributor to Merck’s sales growth. In a very short span of time, Keytruda has become Merck’s largest product. It is already approved for use in 12 indications across eight different tumor types in the United States.

The treatment generated sales of $1.67 billion in second-quarter 2018, up 13.8% sequentially and 89% year over year. Keytruda sales are gaining particularly from strong momentum in the first-line lung cancer indication as it is the only anti-PD-1 approved 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, Incyte INCY, Glaxo GSK and Pfizer separately for the evaluation of Keytruda in combination with other regimens.

Several regulatory decisions for new indications in the United States as well as in Europe are due in the second half of 2018 and 2019, which if approved can further boost sales. A key decision on the label expansion of Keytruda as a first-line treatment for metastatic squamous NSCLC, a difficult-to-treat lung cancer patient population, based on data from the phase 3 KEYNOTE-407 study is expected in October.

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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