Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients

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• dc.contributor.author Brahmer, Julie R.
• dc.contributor.author Bellmunt Molins, Joaquim, 1959-
• dc.contributor.author Ribas, Antoni
• dc.date.accessioned 2024-10-14T06:28:03Z
• dc.date.available 2024-10-14T06:28:03Z
• dc.date.issued 2024
• dc.description.abstract Background: Pembrolizumab has a manageable safety profile as described in its label, which was primarily based on 2799 patients who participated in clinical trials for melanoma or non-small cell lung cancer. Here, we evaluated the safety of pembrolizumab in a broader population of patients from 31 advanced cancer clinical trials across 19 cancer types. Methods: Safety was analyzed in patients who received at least one dose of pembrolizumab (200 mg every 3 weeks [Q3W], 10 mg/kg Q2W or Q3W, or 2 mg/kg Q3W). Adverse events (AEs) and immune-mediated AEs and infusion reactions were evaluated. Results: Safety data from 8937 patients in 31 trials of pembrolizumab monotherapy were pooled (median, seven administrations; range, 1-59). Median duration on treatment was 4.1 months (range, 0.03-40.1). AEs occurred in 96.6% of patients. Grade 3-5 AEs occurred in 50.6% of patients. AEs led to pembrolizumab discontinuation in 12.7% of patients and death in 5.9%. Immune-mediated AEs and infusion reactions occurred in 23.7% of patients (4.6% experienced multiple immune-mediated AEs/infusion reactions) and led to pembrolizumab discontinuation in 3.6% and death in 0.2%. Grade 3-5 immune-mediated AEs occurred in 6.3% of patients. Serious immune-mediated AEs and infusion reactions occurred in 6.0% of patients. Median time to immune-mediated AE onset was 85 days (range, 13-163). Of 2657 immune-mediated AEs, 22.3% were initially treated with prednisone ≥ 40 mg/day or equivalent, and 8.3% were initially treated with lower steroid doses. Conclusions: This pooled analysis of 31 clinical trials showed that pembrolizumab has a consistent safety profile across indications.
• dc.format.mimetype application/pdf
• dc.identifier.citation Brahmer JR, Long GV, Hamid O, Garon EB, Herbst RS, Andre T, et al. Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients. Eur J Cancer. 2024 Mar;199:113530. DOI: 10.1016/j.ejca.2024.113530
• dc.identifier.doi http://dx.doi.org/10.1016/j.ejca.2024.113530
• dc.identifier.issn 0959-8049
• dc.identifier.uri http://hdl.handle.net/10230/61380
• dc.language.iso eng
• dc.publisher Elsevier
• dc.relation.ispartof Eur J Cancer. 2024 Mar;199:113530
• dc.rights © 2024 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
• dc.subject.keyword Neoplasms
• dc.subject.keyword Pembrolizumab
• dc.subject.keyword Programmed cell death 1 receptor
• dc.subject.keyword Safety
• dc.title Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion