Poster Presentation Joint Scientific Meeting of the Australian & NZ Head & Neck Cancer Society & NZ Association of Plastic Surgeons

Time to clinically meaningful changes in pain in patients with advanced cutaneous squamous cell carcinoma treated with cemiplimab in a Phase 2 clinical trial (1415)

Michael R. Migden 1 , Danny Rischin 2 , Stacie Hudgens 3 , Chieh-I Chen 4 , Chrysalyne D. Schmults 5 , Anna C. Pavlick 6 , Alexander Guminski 7 , Axel Hauschild 8 , Zhen Chen 4 , Vera Mastey 4 , Denise Bury 9 , Anne Lynn S. Chang 10 , Guilherme Rabinowits 11 , Sherrif F. Ibrahim 12 , Matthew G. Fury 4 , Siyu Li 4 , Medha Sasane 9
  1. Departments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA
  2. Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia
  3. Clinical Outcomes Solutions, Tucson, AZ, USA
  4. Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
  5. Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
  6. Department of Medical Oncology, New York University Langone Medical Center, New York, NY, USA
  7. Department of Medical Oncology, Royal North Shore Hospital, St Leonards, Australia
  8. Schleswig-Holstein University Hospital, Kiel, Germany
  9. Sanofi, Bridgewater, NJ, USA
  10. Department of Dermatology, Stanford University School of Medicine, Stanford, CA, USA
  11. Department of Hematology and Oncology, Miami Cancer Institute/Baptist Health South Florida, Miami, FL, USA
  12. Department of Dermatology, Rochester Medical Center, Rochester, NY, USA

Purpose: Cemiplimab, a PD-1 inhibitor, is indicated for treatment of cutaneous squamous cell carcinoma (CSCC) in patients with metastatic (mCSCC) or locally advanced (laCSCC) disease not eligible for curative surgery/radiation. Cemiplimab resulted in RECIST objective response rate (complete+partial response) of 44.0%, median times to tumour response of 2.0 months and progression-free survival (PFS) of 18.4 months safety profile was consistent with other anti–PD-1 agents. Cemiplimab-treated patients achieved clinically meaningful (CM) pain reductions (measured using the patient-reported EORTC QLQ-C30 pain domain), which was further characterised by the relationship between time to a CM change in pain and tumour response.

Methodology: 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 and day 1 of each treatment cycle. Kaplan–Meier 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: For pain score at 1st tumour response (cycle 2), the least squares mean change from baseline of responders (–13.8 ±1.7; n=81) differed from that of non-responders (–3.3 ±2.1; n=71) by –10.5 (95% CI: –15.6 to –5.3; P<0.0001); pain reduction was maintained at least through cycle 5 and was independent of opioid pain medication use. For responders, Kaplan–Meier estimated median time to 1st CM pain improvement (2.1 months; n=51) and 1st CM pain worsening (14.8 months; n=77) approximated median times to tumour response (2.0 months; n=85) and PFS (18.4 months; n=193), respectively.

Conclusion: In cemiplimab-treated CSCC patients, 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.


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