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

Clingan, P; Ladwa, R; Brungs, D; Harris, DL; McGrath, M; Arnold, S; Coward, J; Fourie, S; Kurochkin, A; Malan, DR; Mant, A; Sharma, V; Shue, H; Tazbirkova, A; Berciano-Guerrero, MA; Charoentum, C; Dalle, S; Dechaphunkul, A; Dudnichenko, O; Koralewski, P; Lugowska, I; Montaudie, H; Munoz-Couselo, E; Sriuranpong, V; Oliviero, J; Desai, J

Author(s): Clingan, P; Ladwa, R; Brungs, D; Harris, DL; McGrath, M; Arnold, S; Coward, J; Fourie, S; Kurochkin, A; Malan, DR; Mant, A; Sharma, V; Shue, H; Tazbirkova, A; Berciano-Guerrero, MA; Charoentum, C; Dalle, S; Dechaphunkul, A; Dudnichenko, O; Koralewski, P; Lugowska, I; Montaudie, H; Munoz-Couselo, E; Sriuranpong, V; Oliviero, J; Desai, J;
Details: Publication Year 2023,Volume 11,Issue #10,Page e007637
Journal Title: Journal for ImmunoTherapy of Cancer
Publication Type: Research article
Abstract: 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 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 treatment-related deaths were reported. CONCLUSIONS: Cosibelimab demonstrated clinically meaningful ORR and DOR and was associated with a manageable safety profile. TRIAL REGISTRATION NUMBER: NCT03212404.
Publisher: BMJ
Keywords: Humans; *Carcinoma, Squamous Cell/drug therapy; B7-H1 Antigen/metabolism; Programmed Cell Death 1 Receptor/therapeutic use; *Skin Neoplasms/drug therapy; Antibodies, Monoclonal/therapeutic use; Immune Checkpoint Inhibitors/therapeutic use
Department(s): Medical Oncology
PubMed ID: 37848259
Publisher's Version: https://doi.org/10.1136/jitc-2023-007637
Open Access at Publisher's Site: https://doi.org/10.1136/jitc-2023-007637
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-11-30 02:33:21

Last Modified: 2023-11-30 03:03:40