EBMT-EHA CAR-T 2019 meeting
CAR T-cell therapy: transforming outcomes in R/R DLBCL

As an innovative, individualised treatment option, the introduction of Chimeric Antigen Receptor (CAR) T-cell therapy brings with it several unique considerations, which must be addressed to ensure its responsible and effective clinical application for the treatment of relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) after ≥ two lines of systemic therapy. These considerations include but are not limited to the following: a reliable and highly regulated multi-step manufacturing pathway; qualification of treatment centers including additional training and cross-functional collaboration; patient selection criteria; and toxicity understanding and management.

We spoke to experts who provided their insights on these topics during a Kite Satellite Symposium and the scientific session on ‘EMA & Industry Perspective on CAR T in EU’ at the 1st European CAR T-cell meeting in Paris, February 2019. This symposium included discussion on licensed products, and was organized and fully funded by Kite, a Gilead Company.

CAR T-cell therapy: patient selection criteria

Several important questions remain surrounding who should receive CAR T-cell therapy such as axicabtagene ciloleucel, including: what potential predictive markers could there be for CAR-T in R/R DLBCL? Who are the patients who were eligible for CAR-T but did not reach complete remission? We spoke to Steven Le Gouill, MD, PhD, of Nantes University Hospital Center, Nantes, France, on his expert insights.

Preparing your team for CAR T-cell therapy delivery

As a unique therapy with a multi-functional treatment pathway, a facility administering CAR T-cell therapy must utilize a dynamic team of different specialties. Prof. Le Gouill explains the key aspects and importance of the multidisciplinary team required for the management of CAR-T therapy.

CAR T-cell therapy: long-term data and real-world experience

Catherine Thieblemont, MD, PhD, of Saint-Louis Hospital, Paris, France, discusses the latest long-term data that is available for axicabtagene ciloleucel in R/R DLBCL. Prof. Thieblemont also compares the clinical trial data to published real-world evidence, providing her personal insights into results observed with CAR-T treatment for R/R DLBCL in France.

Selecting and preparing patients for CAR T-cell therapy

Uncovering characteristics which may predict responses to a therapy and selecting patients based on these factors can improve outcomes. We spoke to Prof. Thieblemont about the challenges and developments in the selection criteria for CAR-T therapy in DLBCL, in addition to the importance of managing patients’ expectations of CAR-T and their understanding of the treatment journey.

Insights from the interdisciplinary Immuno TaskForce at LMU, Munich

Ludwig Maximilian University (LMU) Hospital in Munich, Germany, is a center with CAR-T experience. Here, Michael von Bergwelt, MD, PhD, of LMU discusses the interdisciplinary Immuno TaskForce at the center, which ensures that patients who receive CAR T-cell therapy have the best care possible before, during and after treatment.

Understanding and managing CAR T-cell therapy toxicities from the interdiscipl

There are a set of toxicities that may potentially be experienced following CAR T-cell therapy, including cytokine release syndrome and neurotoxicity. We discussed the possible adverse events with Prof. von Bergwelt, who explains the mechanism behind them, their frequency, and how best to manage them.

Manufacturing CAR T-cell therapies in Europe

The individualized and cellular approach of CAR T-cell therapy requires a complex, multi-step and tightly controlled manufacturing process. Here, Dominique Tonelli, MD, Head of Medical Affairs for Europe at Kite, a Gilead Company, explains the manufacturing process for axicabtagene ciloleucel, including the unique considerations. Dr Tonelli emphasizes the need for robust and reliable manufacturing to deliver a final product that reaches quality specification in the desired timeframes.

Bringing CAR T-cell therapy to European patients

Dr Tonelli explains the introduction of CAR T-cell therapy in Europe, providing insights into center qualification, risk minimization measures, the chain of custody, and training.

Axicabtagene ciloleucel is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. Axicabtagene ciloleucel must be administered at a qualified clinical setting.

Adverse events should be reported. For the UK, reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
For Ireland, reporting forms and information can be found at www.hpra.ie and can be reported to HPRA on +353 1 6764971.
Adverse events should also be reported to Gilead at safety_FC@gilead.com or +44 (0) 1223 897500.

YESCARTA® (axicabtagene ciloleucel), Kite and the Kite logo are registered trademarks of Kite Pharma Inc © 2019 Kite Pharma, Inc.