In patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), an analysis of health-related quality of life (HRQOL) in the phase 3 TRANSFORM study showed more favorable outcomes for those treated with lisocabtagene maraleucel (liso-cel), compared with standard of care (SOC). Results of this analysis were reported in the journal Blood Advances.
The pivotal TRANSFORM study (ClinicalTrials.gov Identifier: NCT03575351) enrolled patients with LBCL, which was primary refractory or had relapsed in the first 12 months after starting first-line therapy that included anthracycline and a CD20-directed agent. Patients were randomized 1:1 to receive either liso-cel (target dose: 100 x 106 CAR+ T cells) or SOC as second-line therapy. Responders to SOC proceeded to high-dose chemotherapy and autologous stem cell transplantation.
This analysis involved HRQOL-related secondary study objectives. HRQOL was assessed based on results from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 items (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-Lymphoma subscale (FACT-LymS). These assessments occurred at baseline, which was 3 days after randomization and at multiple intervals during and after treatment.
The analysis included patients who were evaluated at baseline and who had at least 1 postbaseline assessment, with 47 patients included from the liso-cel arm and 43 included from the SOC arm. The median age of patients included in EORTC QLQ-C30 analyses was 58 years (interquartile range, 43-66).
Between day 126 and month 6, compared with the SOC arm, the liso-cel arm reportedly showed a greater proportion of patients having meaningful improvements in global health status/quality of life (QOL), and a lower proportion of patients in the liso-cel arm showed deterioration in this measure during this period. Patients in the liso-cel arm also appeared to have more favorable outcomes for fatigue and cognitive functioning during this time frame, compared with the SOC arm.
Between baseline and day 126, overall least-squares mean changes for fatigue and cognitive functioning were clinically meaningfully improved with the liso-cel arm, compared with the SOC arm. For patients of the SOC arm, clinically meaningful worsening was also demonstrated in mean change scores at month 6, compared with baseline, in global health status/QOL, pain, and fatigue, with fatigue also showing a meaningful worsening at day 29.
For global health status/QOL, the time to confirmed deterioration also appeared to be more favorable for the liso-cel arm. The median time to confirmed deterioration was not yet reached in the liso-cel arm, compared with 19.0 weeks in the SOC arm (hazard ratio, 0.47, 95% CI, 0.24-0.94).
The study investigators concluded that this analysis showed favorable HRQOL outcomes with liso-cel, compared with SOC. “Coupled with the superior efficacy results, these data further support the use of liso-cel as a potential new SOC for second-line treatment in patients with early R/R LBCL,” the investigators wrote in their report.
Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
Abramson JS, Johnston PB, Kamdar M, et al. Health-related quality of life with lisocabtagene maraleucel vs standard of care in relapsed or refractory LBCL. Blood Adv. 2022;6(23):5969-5979. doi:10.1182/bloodadvances.2022008106