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

作者：Philip R. Clingan, Rahul Ladwa, Daniel Brungs, Dean Laurence Harris, Margaret McGrath, Susan Arnold, Jermaine Coward, Samuel Fourie, A. Kurochkin, Daniel R Malan, Andrew Mant, Vinay Sharma, Hong Shue, Andrea Tazbirkova, Miguel‐Ángel Berciano‐Guerrero, Chaiyut Charoentum, Stéphane Dalle, Arunee Dechaphunkul, Oleksandr Dudnichenko, P. Koralewski, Iwona Ługowska, Henri Montaudié, Eva Muñoz‐Couselo, Virote Sriuranpong, James Oliviero, Jayesh Desai · 发表于：Journal for ImmunoTherapy of Cancer · 年份：2023 · DOI：10.1136/jitc-2023-007637 · 被引用次数：47 · 研究领域：Nonmelanoma Skin Cancer Studies、Cancer Immunotherapy and Biomarkers、CAR-T cell therapy research

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 immune-related 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...