2026-04-17T22:56:33Zhttps://recercat.cat/oai/request

oai:recercat.cat:10230/613802025-12-22T13:34:33Zcom_2072_6col_2072_452952

urn:hdl:10230/61380 Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients Brahmer, Julie R. Bellmunt Molins, Joaquim, 1959- Ribas, Antoni Neoplasms Pembrolizumab Programmed cell death 1 receptor Safety 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. 2024-10-14T06:28:03Z 2024-10-14T06:28:03Z 2024 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Eur J Cancer. 2024 Mar;199:113530 © 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/). http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess Elsevier