Case-control matching-guided exposure-efficacy relationship for avelumab in patients with urothelial carcinoma.

ABSTRACT: Exposure-response (E-R) analyses are an integral component of understanding the benefit/risk profile of novel oncology therapeutics. These analyses are typically conducted using data from the treatment arm to characterize the relationship between drug exposure (low vs. high) and efficacy or safety outcomes. For example, outcomes of patients with lower exposure in the treatment arm (e.g., Q1) might be compared to outcomes of those with higher drug exposure (Q2, Q3, and Q4). Outcomes from the lowest exposure quartile may be also compared to the control arm to evaluate whether the Q1 subgroup derived clinical benefit. However, the sample size and the distribution of patient baseline characteristics and disease risk factors are not balanced in such a comparison (Q1 vs. control), which may bias

SUBMITTER: Soltantabar P 

PROVIDER: S-EPMC10725265 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature