RT Journal Article
T1 Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma
A1 Clingan, Philip
A1 Ladwa, Rahul
A1 Brungs, Daniel
A1 Harris, Dean Laurence
A1 McGrath, Margaret
A1 Arnold, Susan
A1 Coward, Jermaine
A1 Fourie, Samuel
A1 Kurochkin, Andriy
A1 Malan, Daniel R.
A1 Mant, Andrew
A1 Sharma, Vinay
A1 Shue, Hong
A1 Tazbirkova, Andrea
A1 Berciano-Guerrero, Miguel-Angel
A1 Charoentum, Chaiyut
A1 Dalle, Stephane
A1 Dechaphunkul, Arunee
A1 Dudnichenko, Oleksandr
A1 Koralewski, Piotr
A1 Lugowska, Iwona
A1 Montaudie, Henri
A1 Munoz-Couselo, Eva
A1 Sriuranpong, Virote
A1 Oliviero, James
A1 Desai, Jayesh
K1 Immunotherapy
K1 Programmed Cell Death 1 Receptor
K1 Skin Neoplasms
K1 Immune Checkpoint Inhibitors
AB 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.MethodsIn 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.ResultsObjective 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.ConclusionsCosibelimab demonstrated clinically meaningful ORR and DOR and was associated with a manageable safety profile.
PB BMJ Group
SN 2051-1426
YR 2023
FD 2023-10-17
LK https://hdl.handle.net/10668/28506
UL https://hdl.handle.net/10668/28506
LA en
NO Clingan P, Ladwa R, Brungs D, Harris DL, McGrath M, Arnold S, et al. Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma. J Immunother Cancer. 2023 Oct;11(10):e007637
DS RISalud
RD Aug 19, 2025