Preliminary data from the ongoing TRANSCEND trial showed that patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who were treated with the chimeric antigen receptor (CAR) T-cell therapy JCAR017 achieved a three-month complete remission (CR) rate of nearly 75 percent.
When a lower dose of JCAR017 is included in the analysis, the CR rate at three months was 50 percent. These data will be presented at the 2017 American Society of Hematology Annual Meeting.
One patient in the study experienced a serious case of cytokine release syndrome (CRS), an adverse event commonly associated with CAR T-cell therapy, and approximately one-third of patients reported milder forms of CRS. Serious neurotoxicity was reported in 14 percent of patients, but there were no cases of cerebral edema. No patients enrolled in the study died from either CRS or neurotoxicity.
The U.S. Food and Drug Administration (FDA) previously granted JCAR017 breakthrough therapy designation for non-Hodgkin lymphoma in December 2016, and the drug’s manufacturer plans to file for FDA approval in the second half of 2018. The FDA has already approved two CAR-T cell therapies: axicabtagene ciloleucel (Kite) for the treatment of DLBCL, and tisagenlecleucel (Novartis), which was approved in 2017 for pediatric acute lymphoblastic leukemia. Novartis recently filed a request to expand the tisagenlecleucel indication to include DLBCL.