Cemiplimab (REGN2810) demonstrated a positive risk/benefit profile and produced antitumour activity in patients (pts) with advanced CSCC in the primary analysis, by independent central review, of a phase 1 CSCC expansion cohorts (ECs). We now report longer follow-up data from the CSCC ECs of the phase 1 study (NCT02383212).
Pts with distantly metastatic or unresectable locally/regionally advanced CSCC were enrolled in ECs 7 and 8, respectively. All pts received cemiplimab 3 mg/kg every 2 weeks over 30 minutes by intravenous infusion for up to 48 weeks. Tumour measurements were performed by RECIST 1.1 every 8 weeks to determine overall response rate (ORR; complete response [CR] + partial response [PR]) according to intention to treat. The data cut-off date was 20 Jan, 2018. Tumour response in this report was by investigator assessment.
A total of 26 pts were enrolled (21 M/ 5 F; 10 in EC 7, 16 in EC 8; median age: 72.5 years [range: 55–88]; ECOG performance status was 1 in 16 pts and 0 in 10 pts). Median duration of follow-up was 11.9 months (range: 1.1–18.2). Median duration of cemiplimab exposure was 36.0 weeks. The most common treatment-emergent adverse event (TEAE) of any grade was fatigue (26.9%). The only TEAEs of grade ≥3 that occurred in more than one pt were hypercalcaemia and skin infection (each 7.7%). ORR was 50.0% (95% CI: 29.9–70.1), with 2 CRs and 11 PRs; 5 patients had stable disease (SD), 6 had progressive disease, and 2 were not evaluable for response. Durable disease control rate (SD or response for ≥105 days) was 57.7% (95% CI: 36.9–76.6). Median time to response was 1.9 months (range: 1.7–7.5). The median duration of response has not been reached, and as of the data cut-off date, for pts with CR or PR, the observed duration of response exceeded 6 months in 9 pts and 12 months in 5 pts.
The increasing duration of response in this analysis provides further evidence of a positive risk/benefit profile for cemiplimab in pts with advanced CSCC.
Clinical trial identification
Legal entity responsible for the study
Regeneron Pharmaceutical, Inc. and Sanofi.
The study was sponsored by Regeneron Pharmaceutical, Inc. and Sanofi.
Medical writing support under the direction of the authors was provided by Emmanuel Ogunnowo, PhD, of Prime (Knutsford, UK) and funded by Regeneron Pharmaceuticals, Inc. and Sanofi according to Good Publication Practice guidelines (http://annals.org/aim/fullarticle/2424869/good-publication-practice-communicating-company-sponsored-medical-research-gpp3).
T.K. Owonikoko: Fees for consulting or advisory: Novartis, Celgene, Lilly, Sandoz, Abbvie, Eisai, G1 Therapeutics, Takeda, Seattle Genetics, Bristol-Myers Squibb, MedImmune. A.K. Salama: Fees for consulting or advisory, Speakers’ bureau: Bristol-Myers. E. Calvo: Research funding: Boehringer Ingelheim, Roche/Genentech, BMS, Novartis, PsiOxus, Nanobiotix, Janssen, Abbvie, PharmaMar, PUMA, Sanofi, Lilly, Pfizer, Merck, Nektar, Amcure, Amgen, AstraZeneca, Principia, Bayer, CytomX, H3, Incyte, Kura, LOXO, Macrogenics, Menarini, Merck, Serono, Merus, Millenium, Rigontec, Tahio, TesaroReceipt; Honoraria, Consultation fees: Novartis, Nanobiotix, Janssen-Cilag, PsiOxus Therapeutics, Seattle Genetics, Pierre Fabre, Boehringer Ingelheim, Cerulean Pharma, EUSA, Abbvie, Celgene; Speaker’s bureau fees: Novartis. A. González-Martín: Consulting, advisory, speakers’ bureau, Travel accommodation expenses: AstraZeneca, Tesaro, Roche, Pharmamar. D. Mahadevan: Speakers’ bureau, Travel, accommodation expenses: Abbvie. J. Niu: Consulting, Advisory role: Genentech, Biodesix, Paradigm, Ignyta, AstraZeneca, Teueda. K. Kal Mohan: Employee, Shareholder: Regeneron Pharmaceuticals, Inc. J. Li: Jingjin Employee, Shareholder: Regeneron Pharmaceuticals, Inc., Novartis. E. Stankevich: Employee: Regeneron Pharmaceuticals, Inc.; Shareholder: Regeneron Pharmaceuticals, Inc., Celgene, Bristol-Myers Squibb, Merck. M. Mathias: Employee, Shareholder: Regeneron Pharmaceuticals, Inc. I. Lowy: Employee, Shareholder, Fees Travel and accommodation expenses, Leadership: Regeneron Pharmaceuticals, Inc. M.G. Fury: Employee, Shareholder, Patents, Royalties, Other intellectual property: Regeneron Pharmaceuticals, Inc. H.M. Babiker: Honoraria: Bayer, Sirtex; Consulting, Advisory role fees: Celgene, Endocyte. All other authors have declared no conflicts of interest.