Abstract 1086P
Background
Patients (pts) with advanced cutaneous squamous cell carcinoma (CSCC) have a poor prognosis. A French early access program (EAP) allowed access to cemiplimab (CEM), a PD-1-blocking antibody, (3 mg/kg/2 wks) in 247 pts with locally advanced (la) or metastatic (m) CSCC.
Methods
This was a retrospective analysis of pts with la/m CSCCs treated with CEM from 45 centers. The primary endpoint was best response rate (RR); secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response (DOR) and safety. Response was assessed by investigators. Adverse events (AEs) were graded according to the CTCAEv5. PFS, OS and DOR were estimated using Kaplan–Meier analysis. Data cutoff was 05/05/20.
Results
Of 247 pts enrolled between 8/18 and 10/19, files of 193 pts (141M/52F; mean age 77 yrs ±13) were collected. Half pts received CEM as a 1st line of systemic treatment. 68% of primary CSCCs were located on head and neck. 37% of pts had la CSCC; 36% had regional disease and 27% distant metastases. 26% of pts were immunocompromised. 72% of pts had PS 0/1. Median number of CEM infusions was 10 (0-35). Among 188 pts who received >1 infusion, the best RR was 50% (CI95% 43-57%, 40 CR, 54 PR); DCR was 60%. Median follow-up was 12 mo (1-20). Median PFS was 11 mo (8—NE), median OS and DOR were not reached; 65% (CI95%, 57-73%) of pts were alive 1 yr after starting CEM. Treatment-related Aes (TRAE) were reported in 49 (26%) pts, the most frequent (>2%) being fatigue, hypothyroidism and cholestasis. A total of 18 (9%) pts experienced ≥1 gr. 3–4 TRAE. There were no treatment-related deaths reported, and 10 (5%) pts discontinued therapy because of TRAE (cholestasis and/or cytolysis (3 cases), anorexia, fatigue, anemia, kidney failure, polyarthritis, DRESS syndrome, colitis).
Conclusions
These results strongly suggest that cemiplimab, in the first French pts treated in real life setting, provided a similar benefit to that observed in clinical trials.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Groupe de Cancérologie Cutanée.
Funding
Has not received any funding.
Disclosure
E. Maubec: Advisory/Consultancy: Sanofi; Research grant/Funding (institution): MSD. All other authors have declared no conflicts of interest.