Regeneron Pharmaceuticals, Inc. (REGN - Free Report) along with partner Sanofi (SNY - Free Report) announced positive top-line efficacy results from a pivotal phase II study of its experimental candidate, cemiplimab. The EMPOWER-CSCC 1 study is being conducted on 82 patients with a type of skin cancer: advanced cutaneous squamous cell carcinoma (CSCC).
Cemiplimab is a checkpoint inhibitor targeting PD-1 (programmed death protein 1). The cemiplimab monotherapy study showed an overall response rate (ORR) of 46.3%. The median duration of response (DOR) had not yet been reached at the data cut-off point. At the time of this analysis, all patients had a minimum follow up of six months.
The safety profile in the study was generally consistent with approved anti-PD-1 agents. Notably, for patients with CSCC that cannot be cured by surgery or radiation, there are no FDA-approved treatment options. This is the largest prospective study ever conducted in this disease and many patients were able to achieve deep and durable responses. Hence, the candidate is expected to provide the company with access to a market promising huge potential.
So far this year, shares of Regeneron have gained 4% compared with the industry’s growth of 2.8%.
Per the company’s press release, CSCC is the second most common and deadliest skin cancer after melanoma in the United States. The disease is also responsible for most deaths among non-melanoma skin cancer patients. Although it is easier to apprehend the condition in early stages, it becomes quite difficult to treat the same once progressed to advanced stages.
The data from the EMPOWER-CSCC 1 study will form the basis of a rolling Biologics License Application (BLA) submission to the FDA, which has been initiated and is expected to be completed in the first quarter of 2018. The company also expects to make a filing to the European Medicines Agency (EMA) in the first quarter of 2018.
The results were consistent with the positive phase I trial expansion cohort results reported at ASCO in June, 2017, which led to the candidate receiving Breakthrough Therapy Designation in September.
Zacks Rank & Stocks to Consider
Regeneron has a Zacks Rank #3 (Hold). Some better-ranked health care stocks in the same space are Sucampo Pharmaceuticals (SCMP - Free Report) and Corcept Therapeutics Inc. (CORT - Free Report) holding a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sucampo’s earnings per share estimates have moved up from 3 cents to $1.12 for 2017 and from $1.15 to $1.19 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%. The share price of the company has increased 20.3% year to date.
Corcept’s earnings per share estimates have climbed from 78 cents to 88 cents for 2018, over the last 60 days. The company pulled off a positive earnings surprise in two of the trailing four quarters, with an average beat of 14.32%. The share price of the company has increased 136.4% year to date.
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