|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Nonrelapse mortality associated with chimeric antigen receptor (CAR) T-cell (CAR-T) therapy for relapsed or refractory non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia was “considerably high” at 15%, according to data presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.
CAR-T therapy-emergent toxicities for therapies approved by the US Food and Drug Administration (FDA) that lead to nonprogression-related death have been reported in pivotal studies, but remain underreported elsewhere, according to the researchers.
To look at this more closely, the researchers searched the FDA adverse events reporting system (FAERS) for any adverse events related to tisagenlecleucel (Kymriah®) and axicabtagene ciloleucel (Yescarta®) that were reported from 2013 to 2018.
There were 636 recipients of anti-CD19 CAR-T therapy who were reported in the system: 288 patients received tisagenlecleucel and 348 patients received axicabtagene ciloleucel. Among the 636 patients who received CAR-T, there were 195 deaths, of which 95 were deemed not related to disease progression.
The nonrelapse mortality rate for the whole group was 15%; for tisagenlecleucel it was 21% and for axicabtagene ciloleucel it was 10%. However, the difference in mortality is likely related to different populations, diagnoses, and differences in the CAR-T constructs, the researchers noted. Among the major toxicities reported were cytokine release syndrome, as well as hematological, cardiovascular, neurological, and infectious disease-related adverse effects.
“The promise of CAR-T cells should be balanced against the fact that even in a clinical trial setting, only a minority receive the intended therapy and reach the assessment end point,” the researchers wrote in their study poster. “Nonrelapse mortality needs to be defined prospectively for all ongoing CAR-T studies.”
Read more of Cancer Therapy Advisor‘s coverage of ASCO’s annual meeting by visiting the conference page.
Anand K, Burns E, Sano D, et al. Comprehensive report of anti-CD19 chimeric antigen receptor T cells (CAR-T) associated non-relapse mortality (CART-NRM) from FAERS. Presented at: 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019. Abstract 2540.