Efficacy and safety of tisagenlecleucel in adult Japanese patients with relapsed or refractory follicular lymphoma: results from the phase 2 ELARA trial.

ABSTRACT:

Background

Tisagenlecleucel yielded a high durable response rate in patients with relapsed/refractory (r/r) follicular lymphoma (FL) in the global phase 2 ELARA trial. Here, we report the efficacy, safety, and cellular kinetics of tisagenlecleucel in a subgroup of Japanese patients with r/r FL from ELARA.

Methods

ELARA (NCT03568461) is a global single-arm trial of tisagenlecleucel in patients with r/r FL who received ≥ 2 prior lines of therapy. The primary endpoint was the complete response rate (CRR), and the secondary endpoints were the overall response rate, duration of response, progression-free survival, overall survival, safety, and cellular kinetics.

Results

As of March 29, 2021, nine Japanese patients were enrolled and received tisagenlecleucel with a median f

SUBMITTER: Fukuhara N 

PROVIDER: S-EPMC9889457 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature