Axi-Cel Shows Superior Overall Survival Data vs Standard of Care in LBCL

Axicabtagene ciloleucel (axi-cel) appears to improve overall survival (OS) rates compared with historical standards among patients with relapsed or refractory large B-cell lymphoma (LBCL), according to research presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

In previous years, chemotherapy formed the backbone of care for patients with LBCL, but chimeric antigen receptor (CAR) T-cell therapies have shown promise in the relapsed/refractory setting. Previous data from the randomized phase 3 ZUMA-7 study (ClinicalTrials.gov Identifier: NCT03391466) showed that axi-cel improved event-free survival compared with standard of care.

In this primary OS analysis, 359 patients were randomly assigned to receive axi-cel (180 patients) or standard of care (179 patients). In the overall cohort, the median age was 59 years, 79% of patients had stage III or IV disease, and 74% of patients were primary refractory to treatment. In the standard of care arm, 36% of patients proceeded to stem cell transplantation.

The median follow-up was 47.2 months. At this point, analysis showed that axi-cel improved OS compared with standard of care (hazard ratio [HR], 0.726; 95% CI, 0.54-0.977; one-sided P =.0168), corresponding to a 27.4% reduction in risk of death. When evaluated by most subgroups, however, this OS benefit appeared to disappear.

Progression-free survival also appeared better with axi-cel (HR, 0.506; 95% CI, 0.383-0.669; one-sided P <.0001).

Any-grade cytokine release syndrome was observed in 92% of patients in the axi-cel group vs 0% of patients in the standard of care group. Grade 3 or worse neurological events were also more common with axi-cel (21% vs 1% with standard of care).

“ZUMA-7 confirms axi-cel is a second-line standard of care for patients with refractory or early relapsed LBCL based on superior survival,” said Jason Westin, MD, of the University of Texas MD Anderson Cancer Center in Houston, TX, when presenting the findings.

Disclosures: This research was supported by Kite. Please see the original reference for a full list of disclosures.

Reference

Westin J, Oluwole OO, Kersten MJ, et al. Primary overall survival analysis of the phase 3 randomized ZUMA‑7 study of axicabtagene ciloleucel versus standard‑of‑care therapy in relapsed/refractory large B-cell lymphoma. Presented at: the 2023 ASCO Annual Meeting; June 2-6, 2023. Abstract LBA107.

This article originally appeared on Hematology Advisor