Merck Reports Positive Phase III Liver Cancer Data On Keytruda

Merck & Co., Inc. (NYSE:MRK) announced data from the phase II KEYNOTE-224 study evaluating the use of its anti-PD-1 therapy, Keytruda in patients with advanced hepatocellular carcinoma (HCC)-a form of liver cancer, who were previously treated with systemic therapy (sorafenib). The data showed that treatment with Keytruda monotherapy led to an overall response rate (ORR) of 16.3%. The data also showed complete response rate of 1% and a partial response rate of 15.4% on treatment with Keytruda

The data also included six-month overall survival (OS) and progression-free survival (PFS) rates. The median PFS in the Keytruda arm was 4.8 months with a six-month PFS rate of 43.1 percent. However, the data showed that the median OS was not reached at the time of analysis and the six-month OS rate was 77.9%.

The data was presented presented at the 2018 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium in San Francisco.

Notably, Keytruda is already marketed for several cancer indications, including lung cancer, melanoma, head and neck cancer, classical hodgkin lymphoma and bladder cancer.

Last week, Merck announced that Keytruda, in combination with Lilly’s (NYSE:LLY) Alimta (pemetrexed) and acisplatin or carboplatin, met dual primary endpoints in a phase III KEYNOTE-189 study. The combination was evaluated for the first-line treatment of patients with metastatic non-squamous NSCLC. The study met both its primary endpoints, progression-free survival (PFS) and OS (co-primary endpoint).

We remind investors at the third quarter 2017 call, Merck had mentioned that it is including the overall survival (OS) as a co-primary endpoint in the KEYNOTE-189 study, which could defer the readout from the study to 2019. It was then estimated that the study would complete in February 2019 Therefore the one year earlier than expected positive read out of KEYNOTE-189 study was a big boost to the company.

Shares of Merck have lost 0.9% in the past one year compared unfavorably with the industry’s 23.9% increase.

We remind investors that Keytruda is a key top-line driver for Merck and it brought in $1.5 billion sales in third-quarter 2017, up 18.8% sequentially and 194% year over year. Sales continue to be driven by a launch of new indications globally.

Significantly, Keytruda sales in the United States have gained particularly from a strong momentum in the new indication of first-line lung cancer. Meanwhile, the Keytruda development program also significantly advanced in 2017 with regulatory approvals for four new indications in the United States and two additional diseases in Europe.

Keytruda is continuously growing and expanding into new indications and markets globally. It is under trial for more than 30 types of cancer in above 650 studies including excess of 300 combination studies.

Merck is collaborating separately with several companies namely Amgen, Inc. (NASDAQ:AMGN) Incyte, Glaxo and Pfizer, Inc. (NYSE:PFE) for the evaluation of Keytruda in combination with other regimens.

Zacks Rank

Merck 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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