FDA grants RMAT designation to allogeneic CAR-T for advanced multiple myeloma
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The FDA granted regenerative medicine advanced therapy designation to ALLO-715, an allogeneic chimeric antigen receptor T-cell therapy for adults with relapsed or refractory multiple myeloma, according to the manufacturer.
ALLO-715 (Allogene Therapeutics) is a gene-edited CAR T-cell therapy that targets the B-cell maturation antigen (BCMA) on the surface of cancer cells. The product comprises induced pluripotent stem cells from healthy donors and disrupts the T-cell receptor-alpha constant gene to reduce the risk for graft-versus-host disease. ALLO-715 also uses proprietary Talen (Cellectis) technology to disrupt the CD52 gene and allow for the use of an anti-CD52 monoclonal antibody (ALLO-647, Allogene Therapeutics) to provide selective and prolonged lymphodepletion that may delay graft rejection.
The FDA’s regenerative medicine advanced therapy (RMAT) designation is based on results of the ongoing, multicenter phase 1 UNIVERSAL study. Data presented at last year’s ASH Annual Meeting and Exposition showed a 33% (95% CI, 11.8-61.6) overall response rate among the first 15 patients treated in the study. Four of the five patients who responded to therapy had an ongoing response as of the data cutoff date, and researchers reported no reported incidence of GVHD.
“RMAT designation was granted based on our encouraging initial clinical experience in heavily pretreated patients,” Rafael Amado, MD, executive vice president of research and development and chief medical officer for Allogene, said in a company-issued release.
“ALLO-715 demonstrated for the first time that an allogeneic CAR-T therapy directed at BCMA can achieve deep clinical responses while eliminating the need for bridging therapy and delays associated with autologous CAR-T manufacturing,” he added. “We look forward to completing the UNIVERSAL study and working closely with the FDA as we seek to rapidly advance this important therapeutic alternative to patients with advanced multiple myeloma.”
The FDA’s RMAT designation program is part of the 21st Century Cures Act. The program was created to expedite review of regenerative medicine therapies intended to treat, modify, reverse or cure serious or life-threatening diseases or conditions.
Preliminary clinical evidence must indicate the therapy has the potential to address unmet medical needs for such a disease or condition.
Reference:
Mailankody S, et al. Abstract 653. Presented at: ASH Annual Meeting and Exposition (virtual meeting); Dec. 5-8, 2020.
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