Bristol-Myers Squibb has asked the U.S. Food and Drug Administration (FDA) to approve its investigational CAR T-cell therapy lisocabtagene maraleucel (liso-cel) for people with large B-cell lymphoma who received at least two prior therapies, the company said in a press release.
The biologics license application was based on the latest data from the multicenter Phase 1 TRANSCEND NHL 001 trial (NCT02631044), in which the treatment completely eliminated traces of cancer in more than half (53%) of the diffuse large B-cell lymphoma (DLBCL) patients included in the trial, and partially reduced tumor volume in another 20%.
Updated results from the trial were presented last month at the American Society of Hematology (ASH) 2019 Annual Meeting in San Diego, in a study titled, “Pivotal Safety and Efficacy Results from Transcend NHL 001, a Multicenter Phase 1 Study of Lisocabtagene Maraleucel (liso-cel) in Relapsed/Refractory (R/R) Large B Cell Lymphomas.”
Liso-cel (previously known as JCAR017) is an immunotherapy candidate originally developed by Juno Therapeutics and Celgene, both of which are now part of Bristol-Myers, to treat patients with aggressive forms of B-cell non-Hodgkin’s lymphoma who have not responded well to other treatments.
The investigational medication is a chimeric antigen receptor (CAR) T-cell therapy, a type of treatment that involves collecting a patient’s own immune T-cells and modifying them in the lab to target a specific cancer protein. The genetically engineered cells are then expanded to millions in bioreactors and inserted back into the patient, where they help fight the tumor.
TRANSCEND-NHL-001 is testing the safety and efficacy of liso-cel in relapsed or refractory patients with large B-cell lymphoma, including DLBCL, primary mediastinal B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma.
The latest analysis included 269 B-cell lymphoma patients who received ascending doses of liso-cel: 50 million cells (51 patients), 100 million cells (176 patients), or 150 million cells (41 patients), given as a single into-the-vein (intravenous) injection.