Abstract 818P
Background
While most patients (pts) diagnosed with CSCC are cured with local therapies, for the small percentage developing advanced CSCC the disease is life threatening with dismal prognosis. In a phase 1 (NCT02383212) and a pivotal phase 2 (NCT02760498) clinical trials, cemiplimab, an anti–programmed cell death receptor-1 [anti–PD-1], was the first systemic therapy to demonstrate significant antitumor activity in pts with advanced CSCC. Here, we report results from group 6 of the pivotal phase 2 trial, providing additional efficacy and safety data for cemiplimab monotherapy, 350 mg every 3 weeks (Q3W) up to 104 weeks, in patients with advanced CSCC.
Methods
Patients with advanced CSCC (metastatic [nodal or distant] or locally advanced) were treated with cemiplimab 350 mg intravenous (IV) Q3W for up to 108 weeks. The primary endpoint was objective response rate (ORR; complete response + partial response) per independent central review (ICR). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and overall survival (OS) by central and investigator review as well as safety and tolerability of cemiplimab.
Results
At data cut-off date of Oct 25 2021, 167 pts were enrolled, of which 165 pts received at least one dose of cemiplimab and were followed-up for a median of 8.71 months (range: 0.0 - 19.5). 5 of 167 pts received prior systemic therapies. Per ICR, ORR was 44.3% (74/167, 95% CI: 36.6%, 52.2%) with complete response in 5.4% (9/167), partial response in 38.9% (65/167), and DOR was not reached (95% CI: 13.0 months, not evaluable [NE]). Among treated patients, median PFS was 14.7 months (95% CI: 10.4, NE) and median OS was not reached (95% CI: 17.6 months, NE). The most common treatment-emergent adverse events (TEAEs) by any grade were fatigue (26.1%), diarrhoea and pruritus (each 21.2%), and nausea (17.0%). The most common grade ≥3 TEAEs were hypertension and pneumonia (each 3.6%), and general physical health deterioration (3.0%).
Conclusions
The group 6 primary analysis demonstrates a safety and efficacy profile that is consistent with that of the earlier groups of the study.
Clinical trial identification
NCT02760498.
Editorial acknowledgement
Medical writing support was provided by Osnat Ben-Shahar PhD from Regeneron.
Legal entity responsible for the study
Regeneron Pharmaceuticals, Inc. ((https://clinicaltrials.gov/ct2/show/NCT03088540 Sponsor: Regeneron Pharmaceuticals; Collaborator: Sanofi; Information provided by (Responsible Party): Regeneron Pharmaceuticals).
Funding
Regeneron Pharmaceuticals, Inc., and Sanofi.
Disclosure
B.G.M. Hughes: Financial Interests, Personal, Advisory Board: Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, Roche, Sanofi, Eisai, Pfizer, AstraZeneca, Takeda; Financial Interests, Personal and Institutional, Research Grant: Amgen. J.J. Grob: Financial Interests, Personal, Advisory Board: BMS, MSD, Novartis, Roche, Amgen, Pierre-Fabre, Philogen, Pfizer, Merck, Sanofi; Financial Interests, Personal, Advisory Role: BMS. S.E. Bowyer: Financial Interests, Personal, Advisory Board: Ipsen, Sanofi, Lilly; Financial Interests, Personal, Other: Bristol Myers Squibb , MSD, Australia. F.L. Day: Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Institutional, Other: Bristol Myers Squibb, AstraZeneca. R. Ladwa: Financial Interests, Personal, Other: MSD, BMS, AstraZeneca; Financial Interests, Personal, Advisory Role: AstraZeneca, Roche. B. Stein: Financial Interests, Personal, Stocks/Shares: Icon Group. E. Muñoz Couselo: Financial Interests, Personal, Advisory Board: Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche, Sanofi; Financial Interests, Personal, Other: Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche; Financial Interests, Personal and Institutional, Principal Investigator: Amgen, Bristol Myers Squibb, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche, Sanofi. N. Basset-Seguin: Financial Interests, Personal and Institutional, Invited Speaker: Regeneron/ Sanofi , Sun pharma , Galderma; Financial Interests, Personal and Institutional, Advisory Board: Regeneron/ Sanofi , Sun pharma , Galderma; Financial Interests, Personal and Institutional, Other: Regeneron/ Sanofi , Sun pharma , Galderma. A. Guminski: Financial Interests, Personal, Advisory Board: Regeneron, MSD, Pfizer; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Institutional, Research Grant: Sun Pharma ; Other, Institutional, Other: AZ. L. Mortier: Financial Interests, Personal, Advisory Board: BMS, MSD, Novartis, Pierre FabrE, Merck; Financial Interests, Personal, Principal Investigator: BMS, MSD, Novartis, Pierre Fabre, Merck. A. Hauschild: Financial Interests, Personal, Invited Speaker: Almirall, Amgen, BMS, Merck, Merck Serono, MSD/Merck, Novartis, Neracare, Philogen, Pierre Fabre, Provectus, Regeneron, Replimune, Roche, Sanofi, Sun Pharma; Financial Interests, Personal, Funding: Almirall, Amgen, BMS, Merck, Merck Serono, MSD/Merck, Novartis, Neracare, Philogen, Pierre Fabre, Provectus, Regeneron, Replimune, Roche, Sanofi, Sun Pharma; Financial Interests, Personal, Other: Almirall, Amgen, BMS, Merck, Merck Serono, MSD/Merck, Novartis, Neracare, Philogen, Pierre Fabre, Provectus, Regeneron, Replimune, Roche, Sanofi, Sun Pharma. M.R. Migden: Financial Interests, Personal, Advisory Role: Regeneron, Sanofi, Replimune, Sun pharmaceuticals. C. Schmults: Financial Interests, Personal, Funding: Castle Biosciences, Merck , Regeneron; Financial Interests, Personal, Research Grant: Castle Biosciences, Merck, Regeneron; Financial Interests, Personal, Other: Castle Biosciences, Regeneron , Sanofi, Merck; Non-Financial Interests, Personal, Member of the Board of Directors: American Society of Dermatologic Surgery; Non-Financial Interests, Personal, Advisory Board: International Society of Dermatologic Surgery; Non-Financial Interests, Personal, Officer: National Comprehensive Cancer Network. S. Yoo: Financial Interests, Personal, Full or part-time Employment: Regeneron; Financial Interests, Personal, Stocks/Shares: Regeneron . J. Booth: Financial Interests, Personal, Full or part-time Employment: Regeneron; Financial Interests, Personal, Stocks/Shares: Regeneron . F. Seebach: Financial Interests, Personal, Full or part-time Employment: Regeneron; Financial Interests, Personal, Stocks/Shares: Regeneron . I. Lowy: Financial Interests, Personal, Full or part-time Employment: Regeneron; Financial Interests, Personal, Stocks/Shares: Regeneron . M.G. Fury: Financial Interests, Personal, Full or part-time Employment: Regeneron; Financial Interests, Personal, Stocks/Shares: Regeneron . D. Rischin: Financial Interests, Institutional, Research Grant: Regeneron , Sanofi, Kura Oncology, Roche, Merck Sharp & Dohme, Bristol Myers Squibb, GlaxoSmithKline, ALX Oncology; Financial Interests, Institutional, Funding: Regeneron , Sanofi, Kura Oncology, Roche, Merck Sharp & Dohme, Bristol Myers Squibb, GlaxoSmithKline, ALX Oncology; Non-Financial Interests, Personal, Advisory Role: Merck Sharp & Dohme, Regeneron, Sanofi, GlaxoSmithKline.