Bristol-Myers Squibb seeks FDA biologics license for CAR T-cell therapy in advanced large B-cell lymphoma
Bristol-Myers Squibb has submitted a biologics license application to the FDA for the company’s investigational chimeric antigen receptor T-cell therapy, lisocabtagene maraleucel, for the treatment of adults with relapsed or refractory large B-cell lymphoma who have received two previous lines of therapy.
Lisocabtagene maraleucel is an autologous anti-CD19 CAR T-cell therapy that targets the CD19 antigen expressed on the surface of cancer cells. The investigational compound contains a CAR construct composed of CD8 and CD4 CAR T cells and includes an anti-CD19 single-chain variable fragment that targets the specific antigen domain, a transmembrane domain, a 4-1BB costimulatory domain and a CD3-zeta T-cell activation domain.
The application was submitted based on safety and efficacy results of the open-label, multicenter TRANSCEND NHL 001 trial presented at this year’s ASH Annual Meeting and Exposition. The study included 269 patients who received lisocabtagene maraleucel at one of three dose levels: 50 × 106 (n = 51); 100 × 106 (n = 177); and 150 × 106 (n = 41). The overall response rate was 73% (95% CI, 67-78) with 53% (95% CI, 47-59) of patients achieving complete response to therapy. Treatment responses were similar across all three patient subgroups.
Lisocabtagene maraleucel previously received breakthrough therapy and regenerative medicine advanced therapy designations by the FDA for adults with relapsed or refractory aggressive large B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma or grade 3B follicular lymphoma.