Michael R. Bishop, MD, discussed details from the ZUMA-7 and TRANSFORM trials that were presented at the 63rd ASH Annual Meeting.
Michael R. Bishop, MD, professor of medicine and director of the David and Etta Jonas Center for Cellular Therapy, University of Chicago, spoke with CancerNetwork® at the 2021 American Society of Hematology Annual Meeting about some key research to emerge regarding lymphoma.
Bishop touched on both the TRANSFORM (NCT03575351)1 and ZUMA-7 studies (NCT03391466),2 investigating lisocabtagene maraleucel for transplant-eligible relapsed/refractory aggressive B-cell non-Hodgkin lymphomas and axicabtagene ciloleucel (Yescarta) for relapsed/refractory diffuse large B-cell lymphoma, respectively.
I’ll come back to the ZUMA-7 and TRANSFORM [trials]. We were expecting similar results [in our trial]3 to what was seen from these [trials]. The results from those 2 trials could be practice changing in terms of the application of CAR T-cells earlier in [the treatment] process. There’s a very nice editorial [in the] New England Journal of Medicine that accompanied our paper and the ZUMA-7 trial trying to look at these 3 studies and some of the factors that go into [applying CAR T-cells earlier in treatment], but it does show that there is a distinction. What I’ve taken away from it is that for at least these patients with primary refractory and early relapse, CAR T-cells do appear to provide a treatment option that improves progression-free survival and a potential suggestion overall survival [advantage], and that it is an important treatment option. The question [that has] arisen is what about those patients in the second line who relapse beyond 12 months? This is a controversial area. There’s an argument that autologous transplantation would still be the standard of care and that CAR T-cells would be an option for them afterwards. There’s also the school of thought among many investigators that the results of ZUMA-7 and TRANSFORM can be extrapolated and applied to patients beyond 12 months. I know that both companies have put in an [NDA] to the FDA. They’re looking to get an indication for second line therapy in a broad patient population. Whether or not the FDA takes that latter argument is to be determined, but I strongly hope at a minimum that we will have this as an FDA indication for those patients [who relapse in 12 months or less].