The FDA has set a deadline of 28 October for its review of Sanofi’s cemiplimab for a form of skin cancer, as the company tries to join the fast-growing PD-1/PD-L1 inhibitor market.
The US regulator has given a priority review for PD-1-targeting cemiplimab because its first indication – cutaneous squamous cell carcinoma (CSCC) – is the second most common form of skin cancer after basal cell carcinoma (BCC) and the deadliest after melanoma, with no approved therapies.
Regeneron-partnered cemiplimab is the first of the new wave of checkpoint inhibitors to be filed for CSCC, and also picked up a breakthrough designation from the FDA last September. It was filed in Europe in April, setting up a potential approval in early 2019.
With five drugs targeting PD-1 or PD-L1 already on the market, Sanofi and Regeneron are late entrants into the category. Selecting CSCC for the first marketing application will however allow them to build a niche for cemiplimab before going head-to-head with other drugs such as Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck & Co’s Keytruda (pembrolizumab).
That said, it may not have the market to itself for very long. Keytruda is in phase II testing for CSCC, and the wealth of clinical experience with the drug will make it a potent rival even if Sanofi and Regeneron have first-mover advantage.
The drug is one of a new crop that Sanofi is counting on to stimulate renewed growth, after a difficult period caused by the loss of patent protection for diabetes blockbuster Lantus (insulin glargine) and a poor start for dengue vaccine Dengvaxia.
At its R&D day towards the end of 2017, the French pharma group took pains to highlight cemiplimab’s potential as a first-line therapy for non-small cell lung cancer (NSCLC), an indication which is fast becoming the main battleground for the PD-1/PD-L1 class and at the moment is dominated by Keytruda. Sanofi has three trials of cemiplimab either ongoing or planned in first-line NSCLC.
The company is pushing forward with its checkpoint inhibitor on a number of fronts, however, and is also expecting to report data in the coming months in BCC, another cancer for which none of the first five PD-1/PD-L1 drugs have been approved, as well as cervical cancer. It also has phase II trials ongoing in combination with Sanofi’s CD38-targeting antibody isatuximab in solid tumours and blood cancers, and early-stage studies of cemiplimab with DNA vaccines and oncolytic viruses.
Priority review for Keytruda in NSCLC
Meanwhile, Merck (known as MSD outside the US and Canada) had some good news of its own from the FDA this week. The agency has granted Keytruda a priority review in combination with Lilly’s Alimta (pemetrexed) and platinum-chemotherapy as a first-line treatment for patients with metastatic non-squamous NSCLC.
The filing is based on the KEYNOTE-189 study, which showed Keytruda improved overall survival in this patient group, and is due for judgment by the FDA on 23 September.