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CAR T-cell therapy effective for multiple myeloma

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ORLANDO — LCAR-B38M, a CAR T-cell therapy, appears to be effective among patients with relapsed/refractory multiple myeloma, according to a study presented at the ASH Annual Meeting and Exposition.

“The LEGEND-2 study uses LCAR-B38M, which is a unique, different CAR T with 4-1BB as a costimulation domain and it has two b-cell maturation antigen (BCMA) single-domains,” Bai-Yan Wang, MD, PhD, from the department of hematology at the Second Affiliated Hospital of Xi'an Jiaotong University, Xi’an, China, said during her presentation.

Wang presented a long-term follow-up (median, 19 months) of the LEGEND-2 trial including 57 patients with relapsed/refractory multiple myeloma from the Xi’an site to determine the safety and effectiveness of LCAR-B38M.

Cyclophosphamide was used to conduct lymphodepletion in participants over 3 days. All patients received LCAR-B38M (median CAR+ T cells, 0.5 × 10 cells/kg; range, 0.07–2.1 × 10) in three split infusions.

Most patients showed peak levels of LCAR-B38M, defined as 1 x 10 copies/g or more genomic DNA, in their blood. At 4 months, LCAR-B38M was not detected in 71% of patients’ peripheral blood. In five patients, CAR T cells were persistent for up to 10 months.

Patients demonstrated an overall response rate of 88% (95% CI, 76–95). Seventy-four percent of patients achieved complete response, 4% of patients achieved very good partial response and 11% of patients achieved partial response. Most patients with complete response were minimal residual disease negative. Patients had a median time to first response of 1.2 months.

Best response and baseline BCMA expression level or weight-adjusted CAR+ cells infused did not appear to be related.

At month 18, there was an OS rate of 68% and the median duration of response was 22 months. For the same time frame, there was a PFS rate of 50% for all patients and a PFS rate of 71% for minimal residual disease negative patients. Overall median PFS was 20 months. For minimal residual disease negative patients with complete response, median PFS was 28 months.

All patients experienced adverse events, such as pyrexia (91%), cytokine release syndrome (90%), thrombocytopenia (49%), and leukopenia (47%).

Over the course of the study, 17 patients died, mainly due to progressive disease.

“A confirmatory study is ongoing in China in seven sites and in the U.S.,” Wang said. – by Alaina Tedesco

Reference:

Wang BY et al. Abstract 579. Presented at: ASH Annual Meeting and Exposition; Dec. 7-10, 2019; Orlando.

Disclosure: Wang reports no relevant financial disclosures.