Dr. Nastoupil of the University of Texas MD Andreson Cancer Center, discusses results from the TRANSCEND FL study that she presented during the Eleventh Annual Meeting of the Society of Hematologic Oncology.
The phase II study evaluated the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (liso-cel) in patients with relapsed or refractory follicular lymphoma.
“Liso-cel looks to be particularly attractive because at least, again, in other histologies, it has a favorable toxicity profile, very few incidences of grade three or higher toxicity,” she said.
Dr. Nastoupil spoke about the research and key considerations that informed the design of the single-arm phase II TRANSCEND FL study.
“Over the last five years we’ve seen CAR-T cell therapy transform the management for aggressive lymphomas, and particularly for those with chemo-refractory disease,” Dr. Nastoupil said. “Now, CD19 is a great target for any B-cell lymphoma, so the natural progression is to move it into other B-cell lymphoma histologies … I think the challenge is, how do you define a population in follicular lymphoma that warrants more intensive therapy such as CAR T cell therapy that’s going to be associated with a heavy cost of delivery that care but also potential toxicity?”
Dr. Nastoupil described the safety and efficacy data observed in the study.
“The safety looks really promising,” she said. “That is really exciting because the efficacy looks equally promising … 97% of patients had a response, 94% had a complete response.”
She also spoke about what she sees on the horizon for the use of liso-cel in this population of patients.
“I anticipate that this single-arm phase II study will lead to an [US Food and Drug Administration] approval,” Dr. Nastoupil said.
Further research is also underway, she said, noting that the “critical” question is if liso-cel is “more effective and potentially as tolerable as some of the standard-of-care options.”
“We’ll have to wait and see what those phase III studies look like, but in the meantime, I do think this will offer a very well-tolerated and effective treatment strategy for those patients with poor-risk or high-risk disease,” Dr. Nastoupil said.