At one-year follow-up, phase 2 clinical trial results showed that most patients with relapsed or treatment resistant mantle cell lymphoma responded to chimeric antigen receptor (CAR)-T cell therapy.
Patients with mantle cell lymphoma whose disease has relapsed or become resistant to prior treatment may benefit from chimeric antigen receptor (CAR)-T cell therapy, according to one-year follow-up study findings published online in the New England Journal of Medicine.
Results from the phase 2 ZUMA-2 clinical trial, led by researchers from The University of MD Anderson Cancer Center, showed that the therapy was safe and effective in this patient population across 20 cancer centers.
KTE-X19, a type of CAR-T cell therapy, was given to 68 patients who were a median age of 65, most (84%) were men and more than 80% had stage 4 disease. In addition, intermediate to high-risk mantle cell lymphoma was diagnosed in more than half of the patients.
Patients had all received up to five therapies prior to being given KTE-X19, including a Bruton’s tyrosine kinase (BTK) inhibitor. “BTK inhibitor therapy has greatly improved outcomes in patients with relapsed or refractory mantle cell lymphoma, yet patients who have disease progression after receiving the treatment are likely to have poor outcomes, with median overall survival of just six to 10 months,” stated a press release from MD Anderson.
However, after receiving the CAR-T cell therapy, 93% of patients responded to KTE-X19, including 67% who saw no signs of cancer following treatment. At a median one year-follow up, 57% of patients were in complete remission and overall survival was 83%. Progression-free survival, or the time after treatment without a patient’s disease worsening or death, was estimated to be 61%. At the time of the analysis, 76% of all treated patients in the study were alive, noted the researchers.
“ZUMA-2 is the first multi-center, phase 2 study of CAR T-cell therapy for relapsed/refractory mantle cell lymphoma, and these efficacy and safety results are encouraging,” Dr. Michael Wang, professor of lymphoma and myeloma, said in a press release. “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 side effects were neutropenia and thrombocytopenia. Cytokine release syndrome, or a rapid release of cytokines into the blood, occurred in 15% of patients and neurologic events in 31%. Both side effects are common when using CAR-T cell therapy, but all were managed in patients and no one died.
CAR-T cell therapy involves removing a patient’s T cells, genetically reengineering them in a lab and then infusing them back into the patient with a hope that these new T cells will attack the cancer cells. Two CAR-T therapies have already been approved by the Food and Drug Administration (FDA) — Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) — for the treatment of some adults and younger patients with certain blood cancers.
In February, the FDA granted a priority review to KTE-X19 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma and is set to make its approval decision by Aug. 10, 2020.