ASH 2021 | TRANSFORM: Phase III study of liso-cel versus standard of care for R/R LBCL

Salvage chemotherapy followed by autologous stem cell transplantation (ASCT) is a standard of care (SOC) second line treatment for patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). However, outcomes in this patient population remain poor. Lisocabtagene Maraleucel (liso-cel) is a CD19-directed CAR T-cell product thought to have promise in this space. In the previously reported TRANSCEND-NHL-001 study (NCT02631044), liso-cel treatment was shown to elicit high response rates in patients with LBCL with 2 or more prior lines of treatment. In this press briefing, Manali Kamdar, MD, University of Colorado Cancer Center, Denver, CO, shares the interim findings of the Phase III, randomized, multicenter TRANSFORM study (NCT03575351) of liso-cel compared to SOC (salvage chemotherapy plus ASCT) for the second line treatment of patients with R/R LBCL. A total of 184 patients were randomized 1:1. Patients in the SOC arm were able to crossover to receive liso-cel if they did achieve partial response after 3 cycles of chemotherapy, were not in complete response (CR) after ASCT, or had progressive disease. The results showed that patients treated with liso-cel had a statistically significant improvement in event-free survival compared to those in the SOC arm (10.1 months versus 2.3 months). Progression-free survival and CR rates were also significantly improved. No new safety sinals were detected for liso-cel use in this setting. Overall, these pivotal results support the use of liso-cel as a new SOC for second line treatment of R/R LBCL. This press briefing was recorded at the American Society of Hematology (ASH) 2021 Annual Meeting and Exposition in Atlanta, GA.