Date: 2017-12-13
Type of
information: Results
phase: 2
Announcement: initiation of the trial
Company: Regeneron Pharmaceuticals (USA - NY) Sanofi (France)
Product: REGN2810 - cemiplimab
Action
mechanism:
- monoclonal antibody/immune checkpoint inhibitor. REGN2810 is a fully human monoclonal antibody to Programmed Death-1 (PD-1).
- Cemiplimab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement, and was invented by Regeneron using the company's proprietary VelocImmune® technology.
Disease: advanced cutaneous squamous cell carcinoma
Therapeutic
area: Cancer - Oncology
Country: Australia, Germany, USA
Trial
details:
- This phase 2 study is estimating the clinical benefit of REGN2810 monotherapy for 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 (ORR), according to central review. (NCT02760498)
Latest
news:
- • On December 13, 2017, Regeneron Pharmaceuticals and Sanofi announced positive topline results from a pivotal Phase 2 clinical study of cemiplimab in 82 patients with advanced cutaneous squamous cell carcinoma (CSCC). Cemiplimab, an investigational human antibody targeting PD-1 (programmed cell death protein 1), demonstrated an overall response rate (ORR) of 46.3%, as determined by independent review. The median duration of response (DOR) had not yet been reached at the data cut-off point (32 of 38 responses are ongoing). At the time of this analysis, all patients had a minimum follow up of 6 months. The safety profile in the study was generally consistent with approved anti-PD-1 agents.
- These pivotal data 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. A rolling BLA submission allows for portions of the regulatory application to be submitted to the FDA as they are completed. A submission to the European Medicines Agency (EMA) is also expected to be completed in the first quarter of 2018. These data confirm the positive Phase 1 clinical trial expansion cohort results reported at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, which led to a Breakthrough Therapy Designation for cemiplimab in advanced CSCC in September 2017.
The efficacy data reported here include results from 82 patients in the Phase 2 EMPOWER-CSCC 1 study. Approximately two-thirds of patients had progressed after prior systemic chemotherapy or radiation. EMPOWER-CSCC 1 is a single-arm, open-label clinical trial and remains active. Enrollment is complete in the study arm of patients with metastatic CSCC receiving a 3 mg/kg dose of cemiplimab every two weeks. Enrollment continues in the remaining two study arms of patients with metastatic CSCC receiving a 350 mg flat dose of cemiplimab every three weeks and patients with locally advanced and unresectable CSCC receiving a 3 mg/kg dose of cemiplimab every two weeks.
- Updated results from both the EMPOWER-CSCC 1 and the Phase 1 clinical trial will be submitted for presentation at a 2018 medical congress.
- • On April 8, 2016, a Phase 2 trial sponsored by Regeneron Pharmaceuticals was published on the NIH website ClinicalTrials.gov for REGN2810 and is currently recruiting participants.
Is
general: Yes
