Merck's Keytruda Improves Survival In Esophageal Cancer Study

Merck & Co., Inc. (NYSE:MRK) announced that its PD-L1 inhibitor, Keytruda significantly improved overall survival (OS) compared to standard chemotherapy in a phase III study evaluating it for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma. Esophageal cancer is a difficult-to-treat cancer. It is the seventh most commonly diagnosed cancer and is estimated to be diagnosed in more than 17,000 adults in the United States this year.

However, statistical significance for OS was not reached in two patient groups — patients with squamous cell histology and in the entire intention-to-treat (ITT) study population — in the study. Merck will present the results at an upcoming medical conference and will also submit the same to regulatory authorities for approval to be included in the drug’s label.

The study (KEYNOTE-181) was conducted in patients with advanced esophageal or esophagogastric junction carcinoma whose tumors express PD-L1 with a Combined Positive Score or CPS of 10 or greater. While OS was the primary endpoint of the study, secondary endpoints of the study were progression-free survival (PFS) and objective response rate (ORR), which were not formally tested.

Another phase III study, KEYNOTE-590, is evaluating Keytruda in combination with chemotherapy as a first-line treatment for patients with esophageal carcinoma.

So far this year, Merck’s shares have outperformed the industry. Merck’s shares have risen 31.6% in the period compared with 7.6% increase for the industry.

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 12 indications across eight different tumor types in the United States. Additionally, earlier this week, Merck announced FDA approval of Keytruda for the treatment of advanced hepatocellular carcinoma (HCC), the most common type of liver cancer in patients, previously treated with Bayer/Amgen’s (NASDAQ:AMGN) Nexavar (sorafenib).

Keytruda generated sales of $1.89 billion in the third quarter, up 13% sequentially and 80% year over year. Sales were driven by the launch of new indications globally. 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 as a monotherapy as well as a combination therapy.

The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 850 studies, including more than 400 combination studies. Merck is collaborating with several companies including Amgen, Incyte (NASDAQ:INCY) , Glaxo (NYSE:GSK) and Pfizer (NYSE:PFE) separately for the evaluation of Keytruda in combination with other regimens.

Keytruda is being studied in late-stage studies for breast, colorectal, esophageal, gastric, head and neck, hepatocellular, nasopharyngeal, renal and small-cell lung cancers.This year, Merck announced positive data from several late-stage studies on Keytruda for further line extensions.

Several regulatory decisions for new indications in the United States as well as in Europe are pending in late 2018/2019, which if approved can further boost sales. A key FDA approval last month was the label expansion of Keytruda as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC) – a difficult-to-treat lung cancer patient population - based on data from the phase 3 KEYNOTE-407 study.

Though Keytruda had its share of side effects and suffered some major pipeline setbacks, particularly in 2017, it is probably one of the most successful PD-1 and PD-L1 inhibitors in the market now.

Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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