KEY TAKEAWAYS
- A phase 3 clinical trial (TRANSFORM) was conducted to evaluate the efficacy of liso-cel compared to SOC as second-line therapy for relapsed/refractory LBCL.
- HRQOL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – 30 items and the Functional Assessment of Cancer Therapy-Lymphoma subscale.
- Results revealed a significant improvement in global health status/quality of life (QOL) for the liso-cel arm compared to the SOC arm from day 126 to month 6.
- Mean scores for other domains were maintained or improved in both arms.
- The study indicated that HRQOL was either improved or maintained from baseline in patients with relapsed/refractory LBCL in the liso-cel arm versus SOC arm as second-line treatment.
Lisocabtagene maraleucel (liso-cel) has demonstrated encouraging efficacy in clinical trials for individuals with relapsed or refractory large B-cell lymphoma (LBCL). The health-related quality of life (HRQOL) results presented here are from the TRANSFORM study, the first to directly compare liso-cel to SOC as second-line therapy for this group of patients.
Patients who had LBCL that had been resistant to or had relapsed ≤ 12 months after first-line therapy and were candidates for autologous stem cell transplantation were randomly assigned to receive either liso-cel or SOC at a 1:1 ratio (3 cycles of immunochemotherapy in which responders proceeded to high-dose chemotherapy and autologous stem cell transplantation). Human health quality of life was evaluated using the Functional Assessment of Cancer Therapy–Lymphoma subscale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (30-item version).
Patients with ≥ 1 examination postbaseline were considered (liso-cel, n = 47; SOC, n = 43). Significantly more patients in the liso-cel arm than in the SOC arm experienced notable improvement in global health status/quality of life (QOL) from day 126 to month 6, while fewer patients in the SOC arm experienced deterioration. When compared between the two groups, significant declines in global health status/QOL at month 6, fatigue at day 29 and month 6, and pain at month 6 with SOC were observed, while scores for all other domains were either stable or better.
Time to confirm deterioration in global health status/QOL was longer in the liso-cel arm than in the SOC arm (median: not reached vs. 19.0 weeks, respectively; hazard ratio, 0.47; 95% confidence range, 0.24-0.94). Patients with relapsed or resistant LBCL treated with liso-cel as second-line therapy had better HRQOL than those treated with SOC.
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03575351
Abramson JS, Johnston PB, Kamdar M, Ibrahimi S, Izutsu K, Arnason J, Glass B, Mutsaers P, Lunning M, Braverman J, Liu FF, Crotta A, Montheard S, Previtali A, Guo S, Shi L, Solomon SR. Health-related quality of life with lisocabtagene maraleucel vs standard of care in relapsed or refractory LBCL. Blood Adv. 2022 Dec 13;6(23):5969-5979. doi: 10.1182/bloodadvances.2022008106. PMID: 36149968; PMCID: PMC9713278.
