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Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients.
- Brahmer, Julie;
- Long, Georgina;
- Hamid, Omid;
- Garon, Edward;
- Herbst, Roy;
- Andre, Thierry;
- Armand, Philippe;
- Bajorin, Dean;
- Bellmunt, Joaquim;
- Burtness, Barbara;
- Choueiri, Toni;
- Cohen, Ezra;
- Diaz, Luis;
- Shitara, Kohei;
- Kulkarni, Girish;
- McDermott, David;
- Shah, Manish;
- Tabernero, Josep;
- Vogel, Arndt;
- Zinzani, Pier;
- Jafari, Niusha;
- Bird, Steven;
- Snyder, Ellen;
- Gause, Christine;
- Bracco, Oswaldo;
- Pietanza, M;
- Gruber, Todd;
- Ribas, Antoni
- et al.
Published Web Location
https://doi.org/10.1016/j.ejca.2024.113530Abstract
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.
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