The latest three-year follow-up data from the pivotal phase 3 TRANSFORM study has reinforced the therapeutic potential of CAR T-cell therapy in treating aggressive lymphoma, marking a significant advancement in hematologic oncology.
The multicenter, randomized trial evaluated lisocabtagene maraleucel (liso-cel) against standard-of-care (SOC) salvage chemotherapy followed by autologous stem cell transplantation in patients with relapsed or refractory large B-cell lymphoma within 12 months of first-line therapy.
Sustained Clinical Benefits
The extended follow-up data demonstrates that the initial efficacy advantages observed with liso-cel have been maintained over time. Patients receiving CAR T-cell therapy showed significantly improved progression-free survival compared to the standard-of-care arm, with median PFS rates continuing to favor the experimental treatment.
Event-free survival, a key secondary endpoint, also remained superior in the liso-cel group, underscoring the durability of response achieved with cellular therapy. The separation of survival curves between the two treatment arms has persisted throughout the follow-up period.
Patient Population and Treatment Details
The TRANSFORM study enrolled adult patients aged up to 75 years with primary refractory or early relapsed large B-cell lymphoma. Eligible participants had received first-line chemoimmunotherapy containing an anthracycline and rituximab, with disease progression within 12 months of completion.
Patients randomized to the liso-cel arm received lymphodepleting chemotherapy followed by a single infusion of the CAR T-cell product. The control arm received investigator's choice of salvage chemotherapy regimens with intent to proceed to high-dose therapy and autologous stem cell transplantation in responding patients.
Safety Profile and Quality of Life
The safety profile observed during the extended follow-up period remained consistent with previous reports. The most common adverse events associated with liso-cel included cytokine release syndrome and neurological events, which were generally manageable and resolved with appropriate intervention.
Quality of life assessments indicated that patients treated with liso-cel maintained better functional status and reported fewer disease-related symptoms compared to those receiving standard salvage therapy.
Clinical Implications
These long-term results strengthen the position of CAR T-cell therapy as a preferred second-line treatment option for eligible patients with early relapsed or refractory large B-cell lymphoma. The sustained benefit observed at three years suggests that early intervention with cellular therapy may offer the best chance for durable disease control in this challenging patient population.
The findings also contribute to the growing body of evidence supporting the role of CAR T-cell therapy in earlier lines of treatment, potentially changing the traditional treatment paradigm for aggressive lymphomas.
