Cemiplimab

Unassigned

New Medicines

Advanced cutaneous squamous cell carcinoma (cSCC) - first-line

Information

New molecular entity
Sanofi
Regeneron

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Pre-registration (Filed)

May 18: FDA granted priority review for the Biologics License Application for cemiplimab with a PDUFA date of Oct 2018. [8]


Apr 18: Also under review in the US [7].


Apr 18: The EMA has accepted the MAA for review of cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery [7].


Mar 18: Filings planned for 2018 [6].


Dec 17: Data from PII EMPOWER-CSCC 1 will form basis of licensing submission to FDA and EMA in Q1 2018 [5].


Jul 15: Regeneron and Sanofi enter into global collaboration to develop and commercialise new antibody anticancer therapies; Regeneron will be the US commercial lead while Sanofi will act as commercial lead outside the US [4].


Sep 17: Granted breakthrough therapy status in US. US filing planned for Q1 18 [3].

Category

Programmed cell death-1 protein inhibitor (PDCD-1 antibody)
Incidence of SCC is about 10,000 per year in England and Wales. The incidence is higher in Caucasians [2].
Advanced cutaneous squamous cell carcinoma (cSCC) - first-line
Intravenous

Further information

Yes
To be confirmed
www.nice.org.uk/guidance/indevelopment/gid-ta10304

Trial or other data

Sep 17: At the ASCO meeting earlier in the year, Regeneron and Sanofi reported preliminary data from the first 26 subjects in a 400-patient phase 1 trial of cemiplimab in metastatic or inoperable CSCC, revealing an overall response rate of 46% including two complete responses [3].


Mar 16: Regeneron Pharmaceuticals initiated the pivotal PII EMPOWER-CSCC 1 trial to assess the efficacy of REGN 2810 monotherapy in patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Group 1) or with unresectable locally advanced CSCC (Group 2), as measured by overall response rate (NCT02760498). The open-label, non-randomised trial is recruiting 129 patients in the US, Australia and Germany. Collection of primary outcome due to complete May 19 [1].

Non-small cell lung cancer (NSCLC) - first-line

Information

New molecular entity
Sanofi
Regeneron

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

Programmed cell death-1 protein inhibitor (PDCD-1 antibody)
There were 46,403 new cases of lung cancer diagnosed in the UK in 2014. 53% were males and 47% were females. More than 35,000 people die from the condition. 85% are NSCLC [2].
Non-small cell lung cancer (NSCLC) - first-line
Intravenous

Cervical cancer, recurrent or metastatic platinum-refractory

Information

Licence extension / variation
Sanofi
Regeneron

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Programmed cell death-1 protein inhibitor (PDCD-1 antibody)
Annual incidence of cervical cancer in the UK is currently about 3,200; in England, about a third of patients will have some form of chemotherapy [2].
Cervical cancer, recurrent or metastatic platinum-refractory
Intravenous