RT Journal Article
SR Electronic
T1 Phase 2 study of cemiplimab in patients with metastatic cutaneous squamous cell carcinoma: primary analysis of fixed-dosing, long-term outcome of weight-based dosing
JF Journal for ImmunoTherapy of Cancer
JO J Immunother Cancer
FD BMJ Publishing Group Ltd
SP e000775
DO 10.1136/jitc-2020-000775
VO 8
IS 1
A1 Rischin, Danny
A1 Migden, Michael R
A1 Lim, Annette M
A1 Schmults, Chrysalyne D
A1 Khushalani, Nikhil I
A1 Hughes, Brett G M
A1 Schadendorf, Dirk
A1 Dunn, Lara A
A1 Hernandez-Aya, Leonel
A1 Chang, Anne Lynn S
A1 Modi, Badri
A1 Hauschild, Axel
A1 Ulrich, Claas
A1 Eigentler, Thomas
A1 Stein, Brian
A1 Pavlick, Anna C
A1 Geiger, Jessica L
A1 Gutzmer, Ralf
A1 Alam, Murad
A1 Okoye, Emmanuel
A1 Mathias, Melissa
A1 Jankovic, Vladimir
A1 Stankevich, Elizabeth
A1 Booth, Jocelyn
A1 Li, Siyu
A1 Lowy, Israel
A1 Fury, Matthew G
A1 Guminski, Alexander
YR 2020
UL http://jitc.bmj.com/content/8/1/e000775.abstract
AB Background Cemiplimab, a high-affinity, potent human immunoglobulin G4 monoclonal antibody to programmed cell death-1 demonstrated antitumor activity in a Phase 1 advanced cutaneous squamous cell carcinoma (CSCC) expansion cohort (NCT02383212) and the pivotal Phase 2 study (NCT02760498). Here we report the primary analysis of fixed dose cemiplimab 350 mg intravenously every 3 weeks (Q3W) (Group 3) and provide a longer-term update after the primary analysis of weight-based cemiplimab 3 mg/kg intravenously every 2 weeks (Q2W) (Group 1) among metastatic CSCC (mCSCC) patients in the pivotal study (NCT02760498).Methods The primary objective for each group was objective response rate (ORR) per independent central review (ICR). Secondary endpoints included ORR by investigator review (INV), duration of response (DOR) per ICR and INV, and safety and tolerability.Results For Group 3 (n=56) and Group 1 (n=59), median follow-up was 8.1 (range, 0.6 to 14.1) and 16.5 (range, 1.1 to 26.6) months, respectively. ORR per ICR was 41.1% (95% CI, 28.1% to 55.0%) in Group 3, 49.2% (95% CI, 35.9% to 62.5%) in Group 1, and 45.2% (95% CI, 35.9% to 54.8%) in both groups combined. Per ICR, Kaplan–Meier estimate for DOR at 8 months was 95.0% (95% CI, 69.5% to 99. 3%) in responding patients in Group 3, and at 12 months was 88.9% (95% CI, 69.3% to 96.3%) in responding patients in Group 1. Per INV, ORR was 51.8% (95% CI, 38.0% to 65.3%) in Group 3, 49.2% (95% CI, 35.9% to 62.5%) in Group 1, and 50.4% (95% CI, 41.0% to 59.9%) in both groups combined. Overall, the most common adverse events regardless of attribution were fatigue (27.0%) and diarrhea (23.5%).Conclusion In patients with mCSCC, cemiplimab 350 mg intravenously Q3W produced substantial antitumor activity with durable response and an acceptable safety profile. Follow-up data of cemiplimab 3 mg/kg intravenously Q2W demonstrate ongoing durability of responses.Trial registration number Clinicaltrials.gov, NCT02760498. Registered May 3, 2016, https://clinicaltrials.gov/ct2/show/NCT02760498