International Journal of Hematology
Read

A phase 2 study of axicabtagene ciloleucel in relapsed or refractory large B-cell lymphoma in Japan: 1-year follow-up and biomarker analysis

Publication Date Nov 18, 2022

Abstract

Axicabtagene ciloleucel (axi-cel) is an autologous, CD19-targeting chimeric antigen receptor T‑cell therapy. We recently reported the 3-month follow-up results of a phase 2, multicenter, open‑label, single-arm study of axi-cel in Japanese patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) (JapicCTI-183914). Here, we present 1-year efficacy and safety data and biomarker analysis data regarding mechanisms of resistance to axi-cel. Primary and secondary endpoints included investigator-assessed objective response rate (ORR), serious adverse events, and treatment-emergent adverse events. Axi-cel pharmacokinetics were also examined. Biomarker analysis was performed by cytokine measurement, immunohistochemistry, RNA sequencing, and whole-exome sequencing. At a median follow-up of 13.4months, ORR was 86.7% (13/15 patients), and the complete response (CR) rate improved to 53.3% (8/15 patients) due to response conversion. Seven patients experienced disease progression, and one achieved CR after re-treatment with axi-cel. No new safety concerns were detected. Plausible resistance mechanisms to axi-cel varied among patients but included CD19 downregulation, programmed death-ligand 1 upregulation, and increased macrophage and angiogenesis signatures. The 1-year efficacy and safety of axi-cel were confirmed in Japanese patients with R/R LBCL. Resistance to treatment may involve multiple factors, including target antigen loss and an unfavorable tumor environment.Clinical trial registration: Japan Clinical Trials Inform...

Concepts

Refractory Large B-cell Lymphoma CD19-targeting Chimeric Antigen Receptor Patients Experienced Disease Progression Objective Response Rate Large B-cell Lymphoma Axicabtagene Ciloleucel Biomarker Analysis Angiogenesis Signatures Japanese Patients Treatment-emergent Adverse Events

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.