International Journal of Hematology
Read

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

Publication Date Nov 21, 2022

Abstract

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 follow-up of 13.6 months (range, 10.5‒19.3). Per independent review committee, CRR was 100% (95% CI 63.1‒100). Within 8 weeks of infusion, cytokine release syndrome (CRS) of any grade was reported in 6 patients (66.7%); however, no grade ≥ 3 CRS or any grade serious neurological events or treatment-related deaths were observed. Conclusion Tisagenlecleucel showed high efficacy and manageable safety in adult Japanese patients with r/r FL. Moreover, the clinical outcomes were similar to the global population, which supports the potential of tisagenlecleucel in Japanese patients with r/r FL.

Concepts

Tisagenlecleucel In Patients Safety Of Tisagenlecleucel Follicular Lymphoma Adult Japanese Patients Subgroup Of Japanese Patients Cytokine Release Syndrome Japanese Patients Refractory Follicular Lymphoma Prior Lines Of Therapy Independent Review Committee

Round-ups are the summaries of handpicked papers around trending topics published every week. These would enable you to scan through a collection of papers and decide if the paper is relevant to you before actually investing time into reading it.

Climate change Research Articles published between Jan 16, 2023 to Jan 22, 2023

R DiscoveryJan 23, 2023
R DiscoveryArticles Included:  5

Carbon capture and utilization (CCU) is an emerging technology with commercial potential to convert atmospheric carbon dioxide (CO2) into net zero or ...

Read More

Quality Of Education Research Articles published between Jan 16, 2023 to Jan 22, 2023

R DiscoveryJan 23, 2023
R DiscoveryArticles Included:  2

Introduction: The Educational Scholar Program (ESP) is a creative method to focus on the quality of education and the scholarship of education. The ed...

Read More

Gender Equality Research Articles published between Jan 16, 2023 to Jan 22, 2023

R DiscoveryJan 23, 2023
R DiscoveryArticles Included:  5

This study deviates from the predominantly feminist/critical school of thought associated with existing gender studies to apply an interpretivist appr...

Read More

Coronavirus Pandemic

You can also read COVID related content on R COVID-19

R ProductsCOVID-19

ONE PROBLEM . ONE PURPOSE . ONE PLACE

Creating the world’s largest AI-driven & human-curated collection of research, news, expert recommendations and educational resources on COVID-19

COVID-19 Dashboard

Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on “as is” basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The Copyright Law.