Allogene Therapeutics Announces Publication of Durable Response Data from Phase 1 ALPHA/ALPHA2 Trials of the Allogeneic CAR T Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma in the Journal of Clinical Oncology

• Efficacy Comparable to Approved Autologous CD19 CAR Ts: Achieved Overall Response (ORR) and Complete Response (CR) Rates of 58% and 42% Across the Study and 67% and 58% with Pivotal Study Regimen, Respectively
• Durability of Response: Among Patients Who Achieved CR, Median Duration of Response (DOR) of 23.1 Months and Median Overall Survival (OS) Not Reached
• Manageable Safety Profile Consistent with Approved Autologous CD19 CAR T: No Graft-versus-Host Disease (GvHD), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), or High-Grade Cytokine Release Syndrome (CRS)On-Demand Treatment: Median Time to Treatment Two Days from Enrollment
• Foundation for Cema-Cel in ALPHA3 Trial in First Line (1L) Consolidation: Achieved 100% CR in Patients with Low Disease Burden

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T^™) products for cancer and autoimmune disease, today announced the publication of data from its Phase 1 ALPHA and ALPHA2 clinical studies of cemacabtagene ansegedleucel (cema-cel; formerly ALLO-501/A) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL) as a Rapid Communication in the Journal of Clinical Oncology. These results represent the largest dataset of LBCL patients treated with an allogeneic CAR T product and, with a minimum of two years of follow-up, the longest follow-up to date.

“Publication of the Phase 1 ALPHA/ALPHA2 trials in R/R LBCL mark a landmark moment for the field. These findings represent the most robust allogeneic CAR T experience yet presented and show, for the first time, that an “off-the-shelf” CAR T can induce durable complete remissions in a large fraction of patients with heavily pretreated LBCL,” said Frederick L. Locke, MD, Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center and Research Institute (Tampa, FL). “These peer-reviewed results highlight how cema-cel development is on the cutting edge of lymphoma care, particularly with the ALPHA3 trial targeting only those patients who are MRD positive at the end of first-line treatment. If successful, ALPHA3 and cema-cel could transform the treatment paradigm for newly diagnosed patients.”

“With multiple patients in ongoing complete remissions beyond four years, the lingering question of whether an allogeneic CAR T could deliver durable responses has now been answered,” said Zachary Roberts, M.D., Ph.D., Executive Vice President, Research and Development and Chief Medical Officer of Allogene.

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