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

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 (r

SUBMITTER: Brahmer JR 

PROVIDER: S-EPMC11227881 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature