2026-04-17T22:59:59Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/110672024-06-06T08:38:23Zcom_2072_378070com_2072_378040col_2072_378092

Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients Brahmer, Julie Renee Hamid, Omid Garon, Edward Herbst, Roy Long, Georgina André, Thierry Tabernero, Josep Institut Català de la Salut [Brahmer JR] Johns Hopkins Kimmel Cancer Center, Baltimore, USA. [Long GV] Melanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, Australia. [Hamid O] Cedars-Sinai The Angeles Clinic and Research Institute, Los Angeles, CA, USA. [Garon EB] David Geffen School of Medicine at UCLA, Santa Monica, CA, USA. [Herbst RS] Yale School of Medicine, New Haven, CT, USA. [Andre T] Sorbonne Université and Hôpital Saint-Antoine, France. [Tabernero J] Vall d′Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Pulmons - Càncer - Tractament Anticossos monoclonals - Ús terapèutic DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Carcinoma, Non-Small-Cell Lung Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized Other subheadings::Other subheadings::/therapeutic use ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados Otros calificadores::Otros calificadores::/uso terapéutico Neoplasms; Pembrolizumab; Safety Neoplàsies; Pembrolizumab; Seguretat Neoplasias; Pembrolizumab; Seguridad 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. Funding for this study was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD). The funder participated in study design, data analysis and interpretation, and manuscript writing. This work was also supported by a grant from the National Cancer Institute, USA Kidney SPORE (5P50CA101942). 2024-02-19T08:14:11Z 2024-02-19T08:14:11Z 2024-03 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion 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. 0959-8049 https://hdl.handle.net/11351/11067 10.1016/j.ejca.2024.113530 38295556 http://hdl.handle.net/11351/11067 eng European Journal of Cancer;199 https://doi.org/10.1016/j.ejca.2024.113530 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf Elsevier Scientia