First results of a Lysa study from the French Descar-T registry

Dr Gabriel Brisou presents preliminary findings on the utilization of axi-cel in the second-line treatment of patients with early R/R LBCL. In France, real-world data encompassing all patients subjected to approved CAR T-cell therapy are systematically recorded in the DESCAR-T database.

The administration of axi-cel infusion has received approval from French regulatory authorities for patients experiencing LBCL recurrence within one year of initial treatment or exhibiting refractoriness after the first-line therapy.

As of July 2022, approximately 200 patients have undergone axi-cel infusion. Notably, 12% of cases were excluded from infusion primarily due to disease progression. Among those who did receive the infusion, over 85% underwent bridging therapy, with less than half of them exhibiting a positive response.

Regarding safety assessments, observed data include CRS and neurotoxicity, aligning with findings from other trials such as ZUMA-7 and ALYCANTE.

Available efficacy data extend only up to a three-month follow-up period. Once again, OR and CR rates mirror those observed in ZUMA-7 and ALYCANTE, with approximately 60% of patients achieving CR. However, the immature nature of the data due to the brief follow-up period is acknowledged.

In contrast to the ZUMA-7 trial, where bridging therapy was not administered, real-world data presented here indicate that the majority of patients undergo bridging therapy. This discrepancy highlights the need for further investigation into optimizing CAR-T outcomes through the strategic use of bridging therapy.

An additional noteworthy distinction lies in the performance of intermediate PET-CT scans, and the selection of some patients based on a positive PET after four cycles of R-CHOP. A dedicated subgroup analysis of these patients is planned, emphasizing the ongoing exploration of refined strategies in CAR-T therapy.

Reference:

Brisou G, ASH2023. #5138

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