KEY TAKEAWAYS
- The study aimed to investigate the expanded safety profile of pembro, beyond its labeled indications.
- Researchers noticed a consistent safety profile of pembro across various indications in this pooled analysis of 31 clinical trials.
Pembrolizumab (pembro), known for its manageable safety in melanoma and non-small cell lung cancer trials (2799 patients (pts), underwent a comprehensive safety assessment. Julie R. Brahmer and her team aimed to evaluate the safety of pembro in a broader population of pts from 31 advanced cancer clinical trials across 19 cancer types.
Researchers performed an inclusive safety analysis on pts administered pembro, considering various dosing regimens (200 mg every 3 weeks [Q3W], 10 mg/kg Q2W or Q3W, or 2 mg/kg Q3W). The evaluation encompassed adverse events (AEs), immune-mediated AEs, and infusion reactions in pts who received at least one dose of the medication.
About 8937 pts from 31 pembro monotherapy trials were included in the safety analysis, with a median of seven administrations (range: 1-59) and a median treatment duration of 4.1 months (range: 0.03-40.1). AEs occurred in 96.6% of pts, with Grade 3-5 AEs in 50.6%. Pembro discontinuation due to AEs occurred in 12.7%, resulting in death in 5.9%. Immune-mediated AEs and infusion reactions were observed in 23.7% pts (4.6% experienced multiple immune-mediated AEs/infusion reactions) leading to pembro discontinuation in 3.6% and death in 0.2%. Grade 3-5 immune-mediated AEs occurred in 6.3%, with serious cases in 6.0% of pts. The median time to onset of immune-mediated AEs 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% with lower steroid doses.
The study concluded that pembro demonstrates a consistently favorable safety profile across diverse indications based on the comprehensive analysis of 31 clinical trials.
The study is sponsored by Merck Sharp & Dohme LLC and was also supported by the National Cancer Institute, USA
Source: https://pubmed.ncbi.nlm.nih.gov/38295556/
Brahmer JR, Long GV, Hamid O, et al. (2024). “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. Epub 2024 Jan 11. PMID: 38295556.
