Merck's Keytruda Misses One Of Two Goals In Lung Cancer Study

Merck & Co., Inc.’s (NYSE:MRK) late-stage study, evaluating its blockbuster PD-L1 inhibitor Keytruda as first-line treatment for extensive stage small cell lung cancer (SCLC), failed to meet one of the two primary endpoints.

While the phase III KEYNOTE-604 study evaluating Keytruda plus chemotherapy for the above indication met one of its dual primary endpoints of progression-free survival (PFS), it failed to meet the other endpoint of overall survival (OS). The data showed that treatment with Keytruda plus chemotherapy (etoposide plus cisplatin or carboplatin) led to a statistically significant improvement in PFS compared to chemotherapy alone. However, while the combination showed an improvement in OS, the OS results did not meet statistical significance

Merck’s shares were down more than 1% in after-hours trading in response. Merck’s shares have risen 21.5% in the past year compared with the industry’s increase of 12.2%.

Keytruda, Merck’s biggest product, is already approved for use in 20 indications across 12 different tumor types in the United States.

Keytruda generated sales of almost $8 billion in the first nine months of 2019, up around 63% year over year. While the drug’s sales are being driven by the launch of new indications globally, Keytruda’s sales are particularly benefitting from lung cancer indications. Keytruda is presently approved for five indications in lung cancer, mostly non-small cell lung cancer (NSCLC which is the most common form of lung cancer). Small cell lung cancer (SCLC) is quite rare and accounts for about 10 to 15% of all lung cancers. Keytruda is approved for previously treated metastatic SCLC. The latest setback will hurt the company’s growth prospects in lung cancer.

Keytruda is being studied for more than 30 types of cancer in above 1000 studies including 600 plus combination studies. Merck is collaborating with several companies including Amgen (NASDAQ:AMGN) , Incyte (NASDAQ:INCY), Glaxo (NYSE:GSK) and Pfizer (NYSE:PFE) separately for the evaluation of Keytruda in combination with other regimens.

In a separate press release, Merck announced an exclusive global research/licensing deal with Japan’s Taiho Pharmaceutical and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Japan’s Otsuka Pharmaceutical. Per the deal, Merck will get an exclusive global license to Taiho and Astex ‘s small molecule inhibitor candidates for an upfront payment of $50 million. Taiho and Astex are developing small molecule inhibitors against several drug targets, including the KRAS oncogene, which is among the most frequently mutated oncogenes in cancer. In addition to the upfront amount, Merck will also be entitled to make approximately $2.5 billion of potential milestone payments as well as tiered royalties on sales, if any drug emerges from the deal. Merck will take care of the R&D funding and will be responsible for commercialization of any product that receives regulatory approval.

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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