Abstract 1087P
Background
Cemiplimab, a PD-1 inhibitor, is indicated for treatment of cutaneous squamous cell carcinoma (CSCC) in patients (pts) with metastatic (mCSCC) or locally advanced (laCSCC) disease not eligible for curative surgery/radiation. Cemiplimab resulted in RECIST objective response rate (tumour response; complete+partial) of 44.0%, with median times to tumour response of 2.0 months and progression-free survival (PFS) of 18.4 months; the safety profile was consistent with other anti–PD-1 inhibitors. Cemiplimab-treated pts achieved clinically meaningful (CM) reductions in pain measured using the patient-reported EORTC QLQ-C30 pain domain. Interpretation of change in pain was further characterised by the relationship between time to a CM change in pain and tumour response.
Methods
Adults (N=193) with confirmed diagnosis of invasive CSCC received IV cemiplimab 3 mg/kg Q2W (mCSCC n=59; laCSCC n=78) or 350 mg Q3W (mCSCC n=56). The QLQ-C30 was administered at baseline (BL) and day 1 of each treatment cycle. Kaplan–Meier (KM) survival analysis (with censoring at drop-out) was used to estimate time to 1st CM (≥10-point) reduction (improvement) or increase (worsening) in QLQ-C30 pain scores. Pain medication use was captured over the treatment period.
Results
Compared to non-responders, pts with tumour response reported a CM reduction in pain from BL at 1st tumour response (cycle 2) (P<0.0001) (Table); pain reduction was maintained at least through cycle 5 and was independent of opioid pain medication use. KM analysis showed median time to 1st CM pain improvement and 1st CM pain worsening (Table) approximated median times to tumour response and PFS, respectively.
Conclusions
In cemiplimab-treated CSCC pts, early pain reduction tracked with 1st tumour response, and pain worsening with PFS. These results suggest that changes in pain may correlate with tumour response. Table: 1087P
| Clinical responders (complete+partial) | Clinical non-responders (stable+progressive) | All | |
| Baseline pain score, mean ± SD (n) | 26.1 ± 28.4 (81) | 33.7 ± 31.6 (87) | 29.8 ± 30.4 (152) |
| Change from baseline in pain score at 1st tumour response, n | 81 | 71 | – |
| Least squares mean change ± SE | –13.8 ± 1.7 | –3.3 ± 2.1 | – |
| Least squares mean (95% CI) difference vs non-responders | –10.5 (–15.6, –5.3) | – | – |
| Median time to tumour response, months (n) | 2.0 (85) | – | – |
| Median progression-free survival, months (n) | – | – | 18.4 (193) |
| Median time to 1st clinically meaningful pain improvement, months (n) | 2.1 (51) | – | 2.1 (100) |
| Median time to 1st clinically meaningful pain worsening, months (n) | 14.8 (77) | – | 12.9 (142) |
Clinical trial identification
NCT02760498.
Editorial acknowledgement
Editorial writing support was provided by Jay Bienen, PhD, 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: Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Regeneron Pharmaceuticals, Inc.; Honoraria (self), Travel/Accommodation/Expenses: Sanofi; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Genentech; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Eli Lilly; Honoraria (self), Travel/Accommodation/Expenses: Sunpharma. D. Rischin: Research grant/Funding (institution), Non-remunerated activity/ies: Regeneron Pharmaceuticals, Inc.; Research grant/Funding (institution): Roche; Research grant/Funding (institution), Travel/Accommodation/Expenses, Non-remunerated activity/ies: Merck Sharp & Dohme; Research grant/Funding (institution), Non-remunerated activity/ies: Bristol-Myers Squibb; Research grant/Funding (institution), Travel/Accommodation/Expenses, Non-remunerated activity/ies: GlaxoSmithKline; Non-remunerated activity/ies: Sanofi. S. Hudgens: Advisory/Consultancy: Regeneron Pharmaceuticals, Inc. C-I. Chen, Z. Chen, V. Mastey, M.G. Fury, S. Li: Shareholder/Stockholder/Stock options, Full/Part-time employment: Regeneron Pharmaceuticals, Inc. C.D. Schmults: Advisory/Consultancy, Research grant/Funding (self): Castle Biosciences; Advisory/Consultancy, Research grant/Funding (self): Regeneron Pharmaceuticals, Inc.; Advisory/Consultancy: Sanofi; Research grant/Funding (self): Novartis; Research grant/Funding (self): Genentech; Research grant/Funding (self): Merck; Leadership role, Chair for NCCN: National Comprehensive Cancer Network. A.C. Pavlick: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Merck; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Regeneron Pharmaceuticals, Inc.; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Array; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Seattle Genetics; Honoraria (self), Advisory/Consultancy: Amgen; Research grant/Funding (self): Celldex; Research grant/Funding (self): Forance. A. Guminski: Advisory/Consultancy, Travel/Accommodation/Expenses, Non-remunerated activity/ies: Bristol-Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses, Non-remunerated activity/ies: Sun Pharma; Advisory/Consultancy: Merck KGaA; Advisory/Consultancy: Eisai; Advisory/Consultancy: Pfizer; Non-remunerated activity/ies: Astellas; Research grant/Funding (institution), Clinical trial unit support: PPD Australia. A. Hauschild: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Amgen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck Sharp & Dohme /Merck; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pierre Fabre; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Provectus; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Merck Serono; Advisory/Consultancy, Research grant/Funding (institution): Philogen; Advisory/Consultancy, Research grant/Funding (institution): Regeneron Pharmaceuticals, Inc.; Advisory/Consultancy: OncoSec. D. Bury, M. Sasane: Shareholder/Stockholder/Stock options, Full/Part-time employment: Sanofi. A.L.S. Chang: Advisory/Consultancy, Research grant/Funding (self): Regeneron Pharmaceuticals, Inc.; Advisory/Consultancy, Research grant/Funding (self): Merck; Research grant/Funding (self): Novartis; Research grant/Funding (self): Galderma. G. Rabinowits: Advisory/Consultancy: EMD Serono Pfizer; Advisory/Consultancy: Sanofi; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Regeneron Pharmaceuticals Inc.; Advisory/Consultancy: Merck; Advisory/Consultancy: Castle; Shareholder/Stockholder/Stock options: Syros Pharmaceuticals. S.F. Ibrahim: Research grant/Funding (self), Travel/Accommodation/Expenses: Regeneron Pharmaceuticals, Inc.; Research grant/Funding (self): Castle; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Genentech.