CAR T-cell therapy with lisocabtagene maraleucel (liso-cel) resulted in survival benefits for patients with relapsed or refractory large B-cell lymphoma (LBCL) regardless of prior response to first-line therapy, according to subgroup results of the TRANSFORM trial presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
In the phase-3 TRANSFORM trial, adults eligible for autologous stem cell transplantation were randomly assigned to liso-cel or standard of care. The primary analysis of the trial showed significant improvements in event-free survival, complete response rate, and progression-free survival with liso-cel compared with standard of care.
At the meeting, Loretta J. Nastoupil, MD, of the University of Texas MD Anderson Cancer Center, and colleagues presented results from subgroups of TRANSFORM.
Ninety-two patients were randomly assigned to each arm of the trial. Most patients in both arms had refractory disease, and baseline characteristics in both arms were generally well-balanced.
Consistent with the primary analysis, event-free survival, complete response rate, and progression-free survival favored liso-cell in both subgroups of patients compared with standard of care.
For refractory patients, the event-free survival was 12.0 months for liso-cel compared with 2.2 months for standard of care. Complete response rate was 46% vs. 23% for both arms, respectively, and progression-free survival was 19.2 months for liso-cel compared with 4.9 months for standard of care.
For patients with relapsed disease, the event-free survival was not reached for liso-cel compared with 8.3 months for standard of care. The complete response rate was 22% compared with 17%, respectively, and the progression-free survival was not reached for liso-cel compared with 9.0 months for standard of care.
The rate of cytokine release syndrome and neurological events were low in patients with refractory disease and relapsed disease, with no grade 4/5 events.
The researchers wrote that “as refractory LBCL is historically difficult to treat, outccomes for liso-cel in this subgroup are encouraging.”
Nastoupil LJ, Kamdar MK, Chavez JC, et al. Subgroup analyses of primary refractory (refr) vs early relapsed (rel) large B-cell lymphoma (LBCL) from the TRANSFORM study of lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) as second-line (2L) therapy. Abstract #7526. Presented at the 2023 American Society of Clinical Oncology Annual Meeting; June 2-6, 2023; Chicago, Illinois.