Phase III trial results gives hope to B-Cell lymphoma patients
pharmafile | December 14, 2021 | News story | Manufacturing and Production |
Bristol Myers Squibb (BMS) reported that interim assessment data from the Phase III TRANSFORM clinical trial of Breyanzi (lisocabtagene maraleucel; liso-cel) demonstrated significantly improved outcomes in adult patients with relapsed or refractory large B-cell lymphoma (LBCL).
The chimeric antigen receptor (CAR) T-cell therapy removes blood from a patient’s body, enhancing immune cells, or T-cells, to more effectively fight the lymphoma. The cells are then re-infused back into the patient. Breyanzi demonstrated efficacy at treating large B-cell lymphoma patients, who did not respond to initial treatment of chemotherapy.
The international, multicentre, randomised trial analysed Breyanzi as a second-line therapy in LBCL patients, versus the standard-of-care treatment of salvage chemotherapy with subsequent high-dose chemotherapy and autologous hematopoietic stem cell transplant.
“For around three-quarters of patients who don’t respond to the initial chemotherapy, their survival has been a matter of months. Improving outcomes with more efficacious and safe therapies has been a critical unmet need for these high-risk patients for the longest time,” shared Manali Kamdar, MD, CU Cancer Center member, associate professor, Division of Hematology, University of Colorado School of Medicine.
86% of the subjects who received Breyanzi in the trial attained a complete or partial response, while 66% attained a complete response. Event-free survival (EFS) was at a median time of 10.1 months in the patients treated with Breyanzi. This compares to the 2.3 months in the standard-of-care group.
“We were able to get more patients in a complete response with liso-cel than with an autologous stem cell transplant. And we were able to keep patients without relapse for a longer period of time than patients who received standard of care,” Kamdar said.
Large B-cell lymphoma is a form of blood cancer. The term refractory is used to describe when the lymphoma does not respond to treatment. Only half of those diagnosed with large B-cell lymphoma will be successfully treated with chemotherapy.
Ana Ovey
