Abstract 814P
Background
Previous analyses from EMPOWER-CSCC-1 phase 2 study (NCT02760498) demonstrated substantial clinical benefit and an acceptable safety profile with cemiplimab in patients with locally advanced and metastatic CSCC. Here, we provide the final analysis from the study Groups 1, 2 and 3.
Methods
Patients received cemiplimab 3 mg/kg IV every 2 weeks for up to 96 weeks (Group 1, metastatic CSCC; Group 2, locally advanced CSCC) or cemiplimab 350 mg IV every 3 weeks for up to 54 weeks (Group 3, metastatic CSCC). The primary endpoint was objective response rate (ORR; complete + partial response) per independent central review (ICR). This is the final analysis and the final database lock occurred on 01 Mar 2022.
Results
A total of 193 patients were enrolled (Group 1, n=59; Group 2, n=78; Group 3, n=56). Tumour response per ICR, median progression-free survival (PFS) and overall survival (OS) (Table) remain generally consistent with the previous update (data cut-off: 11 Oct 2020). OS at 48 months is 61.8% (95% CI: 54.0-68.7). Overall median duration of response (DOR) was 41.3 months (Table). Fatigue (34.7%) was the most common treatment-emergent adverse event (TEAE) of any grade; hypertension (4.7%) was the most common Grade ≥3 TEAE. Table: 814P
| Group 1 (mCSCC) 3 mg/kg Q2W (n=59) | Group 2 (laCSCC) 3 mg/kg Q2W (n=78) | Group 3 (mCSCC) 350 mg Q3W (n=56) | Total (n=193) | |
| Median duration of follow-up, months, (range) | 18.5 (1.1–41.0) | 15.5 (0.8–43.2) | 17.3 (0.6–43.4) | 15.7 (0.6–43.4) |
| ORR, %, (95% CI) | 50.8 (37.5–64.1) | 44.9 (33.6–56.6) | 46.4 (33.0–60.3) | 47.2 (39.9–54.4) |
| Complete response, n (%) | 12 (20.3) | 10 (12.8) | 11 (19.6) | 33 (17.1) |
| Partial response, n (%) | 18 (30.5) | 25 (32.1) | 15 (26.8) | 58 (30.1) |
| Median DOR, months (95% CI) | NR (20.7–NE) | 41.9 (20.5–54.6) | 41.3 (40.8–46.3) | 41.3 (38.8–46.3) |
| Median PFS, months (95% CI) | 18.4 (7.3–53.2) | 18.5 (11.1–43.8) | 21.7 (3.8–43.3) | 22.1 (10.4–32.3) |
| Median OS, months (95% CI) | 57.7 (29.3–NE) | NR (58.3–NE) | 48.4 (29.5–NE) | NR (56.0–NE) |
CI, confidence interval; DOR, duration of response; NE, not evaluable; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.
Conclusions
The final update confirms the durable response, safety and efficacy of cemiplimab in patients with advanced CSCC. There were no new safety signals identified on longer follow-up. Cemiplimab remains a standard of care option for advanced CSCC.
Clinical trial identification
NCT02760498.
Editorial acknowledgement
Medical writing support and typesetting were provided by Sameen Yousaf, PhD, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi.
Legal entity responsible for the study
Regeneron Pharmaceuticals, Inc., and Sanofi.
Funding
Regeneron Pharmaceuticals, Inc., and Sanofi.
Disclosure
M.R. Migden: Financial Interests, Personal, Other, honoraria and travel expenses: Regeneron Pharmaceuticals, Inc., Sanofi, Novartis, Genentech, Eli Lilly, Sun Pharma; Financial Interests, Institutional, Research Grant: Regeneron Pharmaceuticals, Inc., Novartis, Genentech, Eli Lilly. C. Schmults: Financial Interests, Personal, Other, steering committee membership: Castle Biosciences; Financial Interests, Personal, Other, steering committee membership and consultancy: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Other, consultancy: Sanofi; Financial Interests, Personal, Research Grant: Castle Biosciences, Regeneron Pharmaceuticals, Inc., Novartis, Genentech, Merck; Financial Interests, Personal, Other, chair: National Comprehensive Cancer Network. N. Khushanlani: Financial Interests, Personal, Research Grant: Regeneron, Bristol Myers Squibb, Merck, Novartis, Replimune, GlaxoSmithKline, HUYA, Celgene; Financial Interests, Personal, Advisory Board: Regeneron, Bristol Myers Squibb, Merck, Novartis, Iovance, Instil Bio, Castle Biosciences, Nektar, Incyte , AstraZeneca , Jounce Therapeutics; Financial Interests, Personal, Other, data safety monitoring committee: Incyte , AstraZeneca ; Financial Interests, Personal, Other, honoraria: Genzyme, NCCN (from Pfizer); Financial Interests, Personal, Other, honoraria/study steering committee: Nektar; Financial Interests, Personal, Stocks/Shares: Bellicum Pharmaceuticals, Amarin, Transenetrix. A. Guminski: Financial Interests, Personal, Other, personal fees and travel support: Bristol Myers Squibb, Sun Pharma; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Sun Pharma, Merck KGaA, Eisai , Pfizer; Financial Interests, Personal, Other, travel support: Astellas; Financial Interests, Personal, Other, clinical trial unit support: PPD Australia. A.L. Chang: Financial Interests, Personal, Advisory Role: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Research Grant: Regeneron Pharmaceuticals, Inc., Novartis, Galderma, Merck; Financial Interests, Personal, Other, consulting: Regeneron Pharmaceuticals, Inc., Merck; Financial Interests, Personal, Advisory Board: Merck. K. Lewis: Financial Interests, Personal, Research Grant: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Other, personal fees: Regeneron Pharmaceuticals, Inc. S.E. Bowyer: Financial Interests, Personal, Advisory Board: Sanofi ; Financial Interests, Personal, Sponsor/Funding: Bristol Myers Squibb , Merck Sharp & Dohme Australia. B.G.M. Hughes: Financial Interests, Personal, Advisory Role: Merck Sharp & Dohme, Bristol Myers Squibb, AstraZeneca, Pfizer, Roche, Eisai, Merck; Financial Interests, Institutional, Research Grant: Amgen. D. Schadendorf: Financial Interests, Personal, Other, institutional patients’ fees: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Advisory Board: Amgen , Leo Pharma, Roche, Novartis, Bristol Myers Squibb, Merck-EMD, Incyte , Pierre Fabre, Merck Sharp & Dohme, AstraZeneca, Pfizer , Array, Philiogen; Financial Interests, Personal, Other, speaker fee: Boehringer Ingelheim; Financial Interests, Personal, Other, speaker honoraria and patients’ fees: Roche, Novartis, Bristol Myers Squibb, Merck-EMD; Financial Interests, Personal, Other, speaker honorarium fees: Incyte , Pierre Fabre; Financial Interests, Personal, Other, patients’ fees: Merck Sharp & Dohme, Philiogen; Financial Interests, Personal, Other, steering committee honorarium fees: 4SC. B. Modi: Financial Interests, Personal, Advisory Board: Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Merck; Financial Interests, Personal, Speaker’s Bureau: Regeneron Pharmaceuticals, Inc., Sanofi Genzyme. L. Dunn: Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Research Grant: Regeneron, CUE Biopharma, Nektar pharmaceuticals, Replimune pharmaceuticals. L. Flatz: Financial Interests, Personal, Research Grant: Hookipa Pharma; Financial Interests, Personal, Advisory Board: Philogen. A. Hauschild: Financial Interests, Institutional, Research Grant: Amgen, Bristol Myers Squibb, Merck Sharp & Dohme/Merck, Pierre Fabre, Provectus, Roche , Novartis, erck Serono, Philogen , Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Other, speaker’s honoraria and consultancy fees: Amgen, Bristol Myers Squibb, Merck Sharp & Dohme/Merck, Pierre Fabre, Provectus, Roche , Novartis; Financial Interests, Personal, Other, consultancy fees: Merck Serono, Philogen , Regeneron Pharmaceuticals, Inc., OncoSec. S. Yoo: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Ownership Interest: Regeneron Pharmaceuticals, Inc. J. Booth: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Ownership Interest: Regeneron Pharmaceuticals, Inc. F. Seebach: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Ownership Interest: Regeneron Pharmaceuticals, Inc. I. Lowy: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Ownership Interest: Regeneron Pharmaceuticals, Inc. M.G. Fury: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Ownership Interest: Regeneron Pharmaceuticals, Inc. D. Rischin: Financial Interests, Institutional, Research Grant: Regeneron Pharmaceuticals, Inc., Sanofi, Kura Oncology, Roche, Merck Sharp & Dohme, Bristol Myers Squibb, GlaxoSmithKline , ALX Oncology; Non-Financial Interests, Personal, Other, uncompensated scientific committee and advisory board roles: Merck Sharp & Dohme, Regeneron Pharmaceuticals, Inc., Sanofi, GlaxoSmithKline. All other authors have declared no conflicts of interest.