A unique infusion of KTE-X19, a new Chimeric Antigen Receptor (CAR) T-cell treatment, provides a lasting response in patients with relapsed or refractory mantle cell lymphoma, after failure of treatment with Bruton’s tyrosine kinase inhibitor.
Treatment is associated with a higher rate of severe toxicities.
Why is it important?
Patients with relapsed / refractory disease have an unfavorable prognosis and require new treatment options.
The ZUMA-2 Phase II multicentre trial evaluated 74 patients with relapsed or refractory mantle cell lymphoma who received KTE-X19.
Funding: Kite, a subsidiary of Gilead.
A primary efficacy analysis was carried out in 60 patients treated and followed for 7 months.
The objective response rate was 93% (complete response rate: 67%).
The median follow-up time was 12.3 months.
75% of patients obtained an objective response and 59% a complete response.
As of the data collection deadline, 57% of patients with a complete response were in remission.
At 12 months:
The progression-free survival rate (PFS) was 61%.
The overall survival rate (OS) was 83%.
The rate of adverse events with a grade greater than or equal to 3 was 99%.
The most common were cytopenia (94%) and infections (32%).
Non-fatal cytokine release syndrome and neurological events occurred in 15% and 31% of the patients, respectively.
68% of the patients presented serious toxicities.
Single group study.
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. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2020; 382 (14): 1331-1342. doi: 10.1056 / NEJMoa1914347. PMID: 32242358