Michael Wang, MD,
Axicabtagene ciloleucel (axi-cel; Yescarta) has previously been approved for the treatment of patients with certain types of large B-cell lymphoma who have not responded to other therapies, and this success has led investigators to test axi-cel in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL)—a rare B-cell non-Hodgkin lymphoma that contributes 4200 new patients in the United States each year.1
The anti-CD19 chimeric antigen receptor (CAR) T-cell therapy could be a solution for the remission and relapse observed in patients with MCL. “During this process, drug resistance progressively increases. Eventually, the resistance becomes too much, and the patient stops responding to any therapies and will die from lymphoma,” said Michael Wang, MD, a professor in the department of lymphoma and myeloma at The University of Texas MD Anderson Cancer Center in Houston. Wang added that, with this disease type, patients fail several therapy options and often do not live as long as a year. Their average survival is about 8 months.
Success After Failure
Axi-cel was approved in October 2017 for the treatment of large B-cell lymphoma after at least 2 other kinds of treatment failed for subtypes including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. The approval was based on findings from the ZUMA-1 phase I/II trial (NCT02348216). The primary results of ZUMA-1 presented at the 2017 AACR Annual Meeting showed an ORR of 82% with a CR rate of 54%, and after 8.7 months of follow-up, 39% of patients remained in CR.2
The value of axi-cel in treating R/R MCL will be tested in the multicenter phase II ZUMA-2 clinical trial (NCT02601313) (Figure
). The trial will enroll about 130 patients with an ECOG performance score of 0 or 1 who have received no more than 5 prior therapies. Eligible participants must have received an anthracycline- or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy, and Bruton tyrosine kinase (BTK) inhibitor therapy with ibrutinib (Imbruvica) or acalabrutinib (Calquence).
... to read the full story