Two-year follow-up of TRANSCEND NHL 001 suggests lisocabtagene maraleucel maintains a durable response in R/R large B-cell lymphoma

Follow-up data obtained from the TRANSCEND NHL 001 trial (NCT02631044) demonstrates that treatment with lisocabtagene maraleucel (liso-cel) leads to long-lasting responses in patients with relapsed/refractory large B-cell lymphoma. Below, we summarize the data as presented at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR[MM1] .¹

Liso-cel is an autologous, CD19-directed, defined composition, 4-1BB chimeric antigen receptor (CAR) T-cell product administered at equal target doses of CD8⁺ and CD4⁺ T cells. The therapy was recently approved by the European Commission as a ≥third-line treatment for certain forms of relapsed or refractory large B-cell lymphoma.

Key data

At the 2-year follow-up, the TRANSCEND NHL 001 study met all of its primary and secondary endpoints.

Efficacy

Of the 269 patients who received liso-cel, 257 were evaluable for efficacy:

• 73% overall response rate;
• 53% complete response rate;
• median duration of response was 23.1 months for patients who achieved partial response and 26.1 months for those who achieved complete response;
• median progression-free survival was 6.8 months;
• median overall survival was 27.3 months;
• estimated 2-year duration of response, progression-free survival, and overall survival were 49.5%, 40.6%, and 50.5%, respectively; and
• CAR T-cells were detectable in peripheral blood for up to 4 years.

Safety

• Cytokine release syndrome and neurological events of any grade occurred in 42% and 30% of patients, with a median time to onset of 5 and 9 days, respectfully.
• The most common adverse events within 90 days of infusion were neutropenia (63%), anemia (48%), and fatigue (44%).
• The most frequently reported ≥Grade 3 adverse events were neutropenia (7%), anemia (6%), febrile neutropenia (4%), and thrombocytopenia (4%).
• ≥Grade 3 infections occurred in 12% of patients.

• In total, 100 patients died in the post treatment-emergent period; disease progression was responsible in 86%.

In conclusion, liso-cel demonstrated durable remission rates and a promising safety profile in the 2-year follow-up of TRANSCEND NHL 001. Treatment was associated with a low incidence of severe cytokine release syndrome and neurological events. There were no additional safety concerns observed in this follow-up, and most of the adverse events occurred in the treatment-emergent reporting period.