Cemiplimab versus historical systemic treatments for locally advanced or metastatic cutaneous squamous cell carcinomas: Results from the French study TOSCA
Menée en France à partir de données de vie réelle portant sur 280 patients atteints d'un carcinome épidermoïde cutané de stade localement avancé ou métastatique, cette étude évalue l'efficacité, du point de vue de la survie globale, et la toxicité du cémiplimab par rapport à des traitements systémiques historiques
Background: Cemiplimab an anti-programmed cell death receptor-1 antibody, was approved by the FDA and EMA for patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) ineligible for curative surgery/radiotherapy or with metastatic (m) CSCC. TOSCA study evaluated the real-world effectiveness and safety of cemiplimab compared to historical systemic therapies (HSTs).
Methods: TOSCA (NCT05302297) was a large French retrospective, multicenter study comparing patient with la/mCSCC treated with cemiplimab via the early access program (EAP, 2018–2019) or HST (2013–2018). The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS), duration of response (DoR), overall response rate (ORR), and safety. Effectiveness analysis using inverse probability weighting included a trial-like cohort of only immunocompetent patients meeting the EAP criteria to emulate a randomized clinical trial; safety analysis included all real-life patients.
Findings: The study included 280 real-life patients (cemiplimab: n=147; HST: n=133). The primary effectiveness analysis included a trial-like cohort (cemiplimab: n=129; HST: n=70; median age: 81 and 78 years, respectively). Median follow-up was 20 and 10 months in the cemiplimab and HST arms, respectively; median OS was 21.2 and 9.8 months, respectively (HR 95% CI: 0.57 [0.45–0.73]; P<0.0001); median PFS was 13.7 and 5.3 months, respectively (HR [95% CI]: 0.57 [0.43–0.76]; P=0.0001). Adverse drug reactions occurred in 27% of cemiplimab patients and 33% of HST patients.
Interpretation: TOSCA demonstrated better survival and response outcomes for cemiplimab versus HST in la/mCSCC; emphasizing, the importance of this retrospective studie in the absence of standard comparative trials.
European Journal of Cancer , résumé, 2026