Pimasertib (PIM) versus dacarbazine (DTIC) in patients (pts) with cutaneous NRAS melanoma: a controlled, open-label phase II trial with crossover

Cémiplimab et carcinomes épidermoïdes cutanés localement évolués ou métastatiques : premières données de vie réelle

Introduction Dans l’essai de phase 2 evaluant le cemiplimab (CEM) chez des patients (pts) ayant un carcinome epidermoide cutane (CEC) localement evolue ou metastatique, le taux de meilleure reponse (TMR) etait de 47 % et la survie globale (SG) a un an de 81 %. Une autorisation temporaire d’utilisation (ATU) nominative a permis a ces pts d’acceder au CEM hors protocole. Notre objectif etait d’analyser les donnees d’efficacite et de tolerance de cette ATU. Materiel et methodes Les 58 centres ayant inclus des pts entre le 08/18 et le 10/19 dans cette etude retrospective ont ete sollicites pour completer une fiche standardisee par pt. L’objectif principal etait le TMR, les objectifs secondaires…

Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma

BackgroundWe have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety.MethodsThis randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS.ResultsAt a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 mont…

Cemiplimab for locally advanced and metastatic cutaneous squamous-cell carcinomas: Real-life experience from the French CAREPI study group

Although cemiplimab has been approved for locally advanced (la) and metastatic (m) cutaneous squamous-cell carcinomas (CSCCs), its real-life value has not yet been demonstrated. An early-access program enrolled patients with la/mCSCCs to receive cemiplimab. Endpoints were best overall response rate (BOR), progression-free survival (PFS), overall survival (OS), duration of response (DOR) and safety. The 245 patients (mean age 77 years, 73% male, 49% prior systemic treatment, 24% immunocompromised, 27% Eastern Cooperative Oncology Group performance status (PS) ≥ 2) had laCSCCs (35%) or mCSCCs (65%). For the 240 recipients of ≥1 infusion(s), the BOR was 50.4% (complete, 21%