FDA Calls Regeneron, Sanofi Carcinoma Drug a Breakthrough

FDA Calls Regeneron, Sanofi Carcinoma Drug a Breakthrough September 8, 2017
By Alex Keown, BioSpace.com Breaking News Staff

TARRYTOWN, N.Y. – The powerhouse partnership of Sanofi and Regeneron Pharmaceuticals continues to impress federal regulators. This morning, the two companies announced the U.S. Food and Drug Administration awarded its skin cancer drug Cemiplimab Breakthrough Therapy Status.

A PD-1 inhibitor Cemiplimab (also known as REGN2810) is being developed to treat adult patients with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma. The drug has already received the Fast Track designation from the FDA. The companies are looking at submitting a Biologics License Application for cemiplimab in the early part of 2018. The FDA designation serves to expedite the development and review of drugs that target serious or life- threatening conditions.

If approved, that could mean big money for the two companies. PD-1 inhibitors like Merck’s Keytruda or Bristol-Myers Opdivo have generated more than $2 billion in sales per quarter, according to reports last month.

Cemiplimab is a human, monoclonal antibody targeting the checkpoint inhibitor PD-1. In addition to CSCC, the drug is being developed as a monotherapy for multiple cancers, including basal cell carcinoma and non-small cell lung cancer. It is also being explored in combination with REGN3767, another investigational immunotherapy targeting the checkpoint inhibitor LAG-3. In June, the two companies presented early-stage data that showed cemiplimab led to overall response rate (ORR) of 46.2 percent in CSCC patients. The drug also demonstrated a 69.2 percent disease control rate. The data presented at the American Society of Oncology was pooled from two Phase I cohorts totaling 26 advanced CSCC patients.

When the companies presented the data this year, Kyriakos P. Papadopoulos, senior clinical Investigator at South Texas Accelerated Research Therapeutics, said are limited treatments and no established standards of care for advanced stages of CSCC.

“CSCC has one of the highest mutation rates reported for any cancers, likely contributing to the study findings, which represent a high responder rate to a PD-1 antibody in a solid tumor cancer. These results are promising and suggest the PD-1 pathway is an important therapeutic target in these patients,” Papadopoulos said in a statement.

CSCC is the second most common type of skin cancer in the United States. It can be fatal to non-melanoma skin cancer patients, Although CSCC has a good prognosis when caught early, it can prove especially difficult to treat when it progresses to advanced stages. Patients at this stage can be disfigured due to multiple surgeries to remove CSCC tumors on the head, neck and other parts of the body.

The Sanofi and Regeneron developmental partnership is proving to be a valuable one. This year alone, the two companies have snagged FDA approval for two jointly-developed drugs. In May, the companies gained approval for rheumatoid arthritis drug Kevzara (sarilumab). Data from a Phase III trial released in March showed that sarilumab outperformed AbbVie 's Humira. In March, the FDA approved Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis.

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