Cemiplimab versus historical systemic treatments for locally advanced or metastatic cutaneous squamous cell carcinomas: Results from the French study TOSCA.
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Robert Caroline, Gérard Emilie, Lanoy Emilie, Quéreux Gaelle, Bernard Philippe, Viguier Manuelle, Grange Florent, Meyer Nicolas, Dinulescu Monica, Legoupil Delphine, Neidhardt Eve Marie, Saiag Philippe, Trabelsi Sabiha, Célérier Philippe, Nardin Charlee, Maubec Eve, Duval-Modeste Anne-Benedicte, Hainaut Ewa, Darras Sophie, Maillard Herve, Guegan Sarah, Arnault Jean-Philippe, Stoebner Pierre-Emmanuel, LE Corre Yannick, Peuvrel Lucie, Bonniaud Bertille, Herrscher Hugo, Granel-Brocard Florence, Vataire Anne-Lise, Tabellion Aurore, Lebbé Celeste, Mortier Laurent
Аннотация
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.