Regeneron and its longtime development partner Sanofi are keeping their proverbial fingers crossed that their profitable collaboration will yield yet another approved treatment this year.
This morning the companies announced the U.S. Food and Drug Administration (FDA) has set a PDUFA date of Oct. 28 to determine the fate of its anti-PD-1 skin cancer treatment, cemiplimab. The two companies firmly believe there is still room in the crowded checkpoint inhibitor field dominated by Merck, AstraZeneca and Bristol-Myers Squibb. Merck’s Keytruda or Bristol-Myers Opdivo are responsible for generating billions of dollars in revenue for both companies. And that is something that Regeneron and Sanofi are hoping will occur with cemiplimab as well. In January Regeneron and Sanofi demonstrated their commitment to the development of the drug with an additional $1 billion for research and development. That additional billion dollars means the investment in cemiplimab will be increased to a minimum of $1.64 billion. If the FDA approved cemiplimab in October, it’s quite likely that the two companies will immediately begin planning for approval of the checkpoint inhibitor in other indications.
In the announcement today Regeneron and Sanofi said the FDA granted a priority review for the Biologics License Application for cemiplimab based on impressive topline results from its pivotal Phase II study that continued to show a high response rate in patients. Those results, which were released in December, spurred the companies to begin seeking approval for the checkpoint inhibitor. Additionally, the FDA will consider Phase I data from two advanced CSCC expansion cohorts. Updated results from both clinical trials will be presented at the 2018 ASCO Annual Meeting, the two companies said this morning.
Sanofi and Regeneron are developing the PD-1 inhibitor cemiplimab 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. 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, and 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 Phase II topline results showed that of the 82 patients treated with cemiplimab 46.3 percent demonstrated an overall response rate. Last year the FDA granted the drug Breakthrough Therapy status following the Phase I results.
In addition to submitting cemiplimab for review in the United States, the two companies are also seeking approval in Europe. The European Medicines Agency accepted the Marketing Authorization Application earlier this month.
The Sanofi and Regeneron developmental partnership is proving to be a valuable one. In 2017 the two companies 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 2017 the FDA approved Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis.
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