Article Dans Une Revue Journal for Immunotherapy of Cancer Année : 2023

Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma

Philip Clingan
  • Fonction : Auteur
Rahul Ladwa
  • Fonction : Auteur
Daniel Brungs
  • Fonction : Auteur
Dean Laurence Harris
  • Fonction : Auteur
Margaret Mcgrath
  • Fonction : Auteur
Susan Arnold
  • Fonction : Auteur
Jermaine Coward
  • Fonction : Auteur
Samuel Fourie
  • Fonction : Auteur
Andriy Kurochkin
  • Fonction : Auteur
Daniel R Malan
  • Fonction : Auteur
Andrew Mant
  • Fonction : Auteur
Vinay Sharma
  • Fonction : Auteur
Hong Shue
  • Fonction : Auteur
Andrea Tazbirkova
  • Fonction : Auteur
Miguel-Angel Berciano-Guerrero
Chaiyut Charoentum
  • Fonction : Auteur
Stéphane Dalle
Arunee Dechaphunkul
  • Fonction : Auteur
Oleksandr Dudnichenko
  • Fonction : Auteur
Piotr Koralewski
  • Fonction : Auteur
Iwona Lugowska
  • Fonction : Auteur
Henri Montaudié
  • Fonction : Auteur
Eva Muñoz-Couselo
  • Fonction : Auteur
Virote Sriuranpong
  • Fonction : Auteur
James Oliviero
Jayesh Desai
  • Fonction : Auteur

Résumé

Background Programmed cell death receptor-1 (PD-1)-blocking antibodies are approved to treat metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) cases ineligible for curative surgery or radiation. Notwithstanding, some patients experience inadequate responses or severe immunerelated adverse events (AEs), indicating the need for improved therapies. Cosibelimab is a high-affinity programmed cell death-ligand 1 (PD-L1)-blocking antibody that activates innate and adaptive immunity by blocking PD-L1 interaction with PD-1 and B7-1 receptors. It is an unmodified immunoglobulin G1 subtype with a functional Fc domain capable of inducing antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Here, we present results of the pivotal study of patients with metastatic CSCC from an open-label, multicenter, multiregional, multicohort, phase 1 trial of cosibelimab. Methods In this trial, participants with metastatic CSCC received cosibelimab 800 mg intravenously every 2 weeks. Primary endpoint was objective response rate (ORR) by independent central review using Response Evaluation Criteria in Solid Tumors, V.1.1. Secondary endpoints included duration of response (DOR) and safety. Results Objective response was observed in 37 of 78 participants (47.4% (95% CI: 36.0% to 59.1%)), with median follow-up of 15.4 months (range: 0.4 to 40.5) as of data cut-off. Median DOR was not reached (range: 1.4+ to 34.1+ months), with response ongoing in 73.0% of participants. Common treatment-emergent AEs (≥15%) were fatigue (26.9%), rash (16.7%), and anemia (15.4%). Eighteen participants (23.1%) experienced immune-related AEs (grade 3: n=2 (2.6%); no grade 4/5). No treatmentrelated deaths were reported. Conclusions Cosibelimab demonstrated clinically meaningful ORR and DOR and was associated with a manageable safety profile. Trial registration number NCT03212404.

Domaines

Cancer
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Dates et versions

hal-04941902 , version 1 (12-02-2025)

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Philip Clingan, Rahul Ladwa, Daniel Brungs, Dean Laurence Harris, Margaret Mcgrath, et al.. Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma. Journal for Immunotherapy of Cancer, 2023, 11, ⟨10.1136/jitc-2023-007637⟩. ⟨hal-04941902⟩
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