Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial
Mené en Chine sur 370 patients atteints d'un carcinome épidermoïde de la tête et du cou récidivant ou métastatique, cet essai de phase III évalue l'efficacité, du point de vue de la survie globale, et la toxicité de l'ajout de finotonlimab (un anticorps anti PD-1) au 5-fluorouracile
Immunotherapy combined with chemotherapy regimen has been shown to be effective in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). However, due to the small number of patients, its efficacy remains controversial in Asian populations, particularly in mainland China. Here a randomized, double-blind phase 3 trial evaluated the efficacy and safety of finotonlimab (SCT-I10A), a programmed cell death 1 (PD-1) monoclonal antibody, combined with cisplatin plus 5-fluorouracil (C5F) for the first-line treatment of R/M HNSCC. Eligible patients (n = 370) were randomly 2:1 assigned to receive finotonlimab plus C5F (n = 247) or placebo plus C5F (n = 123). The primary endpoint was overall survival (OS). In the finotonlimab plus C5F group, OS was 14.1 months (95% confidence interval (CI) 11.1–16.4), compared with 10.5 months (95% CI 8.1–11.8) in the placebo plus C5F group. The hazard ratio was 0.73 (95% CI 0.57–0.95, P = 0.0165), meeting the predefined superiority criteria for the primary endpoint. Finotonlimab plus C5F showed significant OS superiority compared with C5F alone and acceptable safety profile with R/M HNSCC, supporting its use as a first-line treatment option for R/M HNSCC. These results validate the efficacy and safety of the combination of finotonlimab and C5F in Asian patients with R/M HNSCC. ClinicalTrials.gov identifier: NCT04146402.
Nature Medicine , résumé, 2024