People with heavily pre-treated mantle cell lymphoma respond positively to chimeric antigen receptor (CAR)-T cell therapy, according to the findings of a clinical trial.
The multi-centre, 20-site, Phase II ZUMA-2 study, led by The University of Texas MD Anderson Cancer Center, enrolled a total of 74 patients. Their median age was 65 years, and 84% were male.
More than 80% of the patients had stage IV disease, and more than half were diagnosed as intermediate to high-risk in a mantle cell lymphoma prognostic index. All had relapsed or refractory disease after receiving up to five therapies, and all had received Bruton’s tyrosine kinase (BTK) inhibitor therapy.
The first 60 patients treated with the CAR-T cell therapy KTE-X19 were included in the primary efficacy analysis. 93% of these 60 patients had an objective response to KTE-X19, with 67% achieving a complete response.
At a median one year-follow up, 57% of patients were found to be in complete remission. The estimated progression-free survival and overall survival were recorded as 61% and 83%, respectively.
76% of all treated patients (68 of the 74 enrolled in the study) were alive at the time of the analysis. The results were published online in the New England Journal of Medicine, and were previously presented at the American Society of Hematology annual meeting in 2019.
Study leader Prof Michael Wang from MD Anderson described the findings as “encouraging”. He said: “Although this study continues, our reported results, including a manageable safety profile, point to this therapy as an effective and viable option for patients with relapsed or refractory mantle cell lymphoma.”
The most common adverse effects included neutropenia and thrombocytopenia. Most patients experienced cytokine release syndrome, a common side effect of CAR T-cell therapy, but the syndrome was effectively managed in all patients.
Source: Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA, Miklos DB, Pagel JM, Kersten MJ, Milpied N, Fung H, Topp MS, Houot R, Beitinjaneh A, Peng W, Zheng L, Rossi JM, Jain RK, Rao AV, Reagan PM (2020) “KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma”, NEJM, doi: 10.1056/NEJMoa1914347
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