Real-World Data on Tolerability and Clinical Response of Cemiplimab in Patients with Advanced Cutaneous Squamous Cell Carcinoma: A Retrospective, Multicentre Cohort Study from the Netherlands

Abstract

Background: Cutaneous squamous cell carcinoma (CSCC) is the second most common cutaneous malignancy and patients with advanced disease have a poor prognosis. Phase I/II clinical studies have shown the efficacy of cemiplimab, a monoclonal anti-PD-1 antibody, for this disease. However, real-world data on tolerability and clinical outcome in larger patient populations is needed to aid clinical decision-making.

Methods: In this retrospective cohort study, patients treated with flat dose cemiplimab 350mg Q3W intravenously for advanced CSCC (aCSCC) from three centres in the Netherlands were retrospectively investigated. Adverse events (AE), tumour response, progression-free survival (PFS) and overall survival (OS) were assessed.

Results: In total, 65 patients (median age 76; range 30-93 years) with locally advanced (29 patients [45%]) or metastatic (36 patients [55%]) CSCC were included. All but 8 patients (88%) had comorbidities and 58 patients (89%) did not receive any prior systemic therapy. Treatment was well-tolerated, with grade 3-4 AEs in 22% of patients. An objective response was seen in 34 patients (52%), of whom 14 (22%) reached a complete response. With a median follow-up of 21.5 months, the median PFS was 10.9 (95% CI, 1.8 – 20.0) and median OS was 26.1 months.

Conclusions: In this real-world cohort of aCSCC patients from the Netherlands, cemiplimab demonstrated to be well-tolerated, even in elderly patients with severe comorbidities, achieving an objective response in 52% of patients. This outcome was comparable to the results of prospective clinical trials.

Note:
Funding declaration: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Conflict of Interests: MR declares to have no competing interests. MD declares to have no competing interests. LD received compensation to the institution for advisory roles and education for Bristol-Myers Squibb, Merck Sharp & Dohme and Incyte. AM declares to have no competing interests. FB declares to have no competing interests. JvT declares to have no competing interests. SW had advisory roles for Eisai, Bristol-Myers Squibb, Pierre Fabre, Novartis and Pfizer. CvH received fees for participation in advisory boards (not personal, but on behalf and paid to the institute) for Bayer, Bristol-Myers Squibb, Elevar, Ipsen, MSD, Regeneron and received research grants from Astra Zeneca, Bristol-Myers Squibb, MSD, Merck, Ipsen, Novartis, and Sanofi. JH received compensation (all paid to the institute except for Neogene Therapeutics) for advisory roles for Achilles Therapeutics, BioNTech, BMS, CureVac, Gadeta, Immunocore, Iovance Bio, Instil Bio, Ipsen, MSD, Merck Serono, Molecular Partners, Neogene Therapeutics, Novartis, Pfizer, Roche/Genentech, Sanofi, Scenic, Seattle Genetics, Third Rock Ventures, T-Knife, and has received grants (all paid to the institute) from Amgen, Asher Bio, BioNTech, BMS, MSD, Novartis, Sastra Cell Therapy.

Ethical Approval: This study was approved by the local institutional review boards (IRBd20-125) and data transfer agreements were constructed for sharing of the data between the centres for central analysis.

Keywords: cutaneous squamous cell carcinoma, cemiplimab, immunotherapy, locally advanced, metastatic