Liso-cel (lisocabtagene maraleucel) is a CD19-directed CAR-T cell therapy marketed as Breyanzi for relapsed or refractory B-cell malignancies. It is used in adult patients with large B-cell lymphoma and additional indications such as CLL/SLL, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma. The FDA first approved Breyanzi in 2021, with subsequent label expansions.
The FDA approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic therapies. In TRANSCEND FL, the CAR T therapy showed a 95.5% overall response rate and 62.1% complete response rate.
The FDA has approved Bristol Myers Squibb's CAR-T therapy Breyanzi for relapsed/refractory marginal zone lymphoma, while a novel multiple myeloma drug candidate DTP3 advances to Phase 2 trials after showing promising early results. Both developments represent significant progress in blood cancer treatment, with the marginal zone lymphoma approval based on a 95.5% response rate and the myeloma drug demonstrating selective cancer cell killing without toxicity.
Phase 2 trial data show lisocabtagene maraleucel achieved a 95% overall response rate in patients with relapsed or refractory marginal zone lymphoma, with a manageable safety profile and no new safety signals.
Lyell Immunopharma has initiated dosing in its Phase III PiNACLE – H2H trial, comparing ronde-cel against approved CAR T-cell therapies for relapsed or refractory large B-cell lymphoma in second-line treatment.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07015242 |
A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma |
RECRUITING | PHASE2 |
| NCT06313996 |
A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma |
WITHDRAWN | PHASE3 |
| NCT06205290 |
A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies |
WITHDRAWN | PHASE3 |
| NCT05621096 |
Low Dose Radiation as Bridging Therapy in Relapsed B-Cell Non-Hodgkin Lymphoma |
ACTIVE_NOT_RECRUITING | PHASE1 |
