Benzinga | Jun 4, 2021 09:09AM EDT

Allogene Therapeutics Highlights Phase 1 Data On ALLO-501 And ALLO-501A In Relapsed/Refractory Non-Hodgkin Lymphoma At 2021 ASCO Meeting

* ASCO Posters Detail Results from ALLO-501 ALPHA and ALLO-501A ALPHA2 Trials in Non-Hodgkin Lymphoma and Safety and PK/PD Data of ALLO-647 with Flu/Cy Across the ALPHA, ALPHA2 and UNIVERSAL Studies Results from Most Recent Data Discussed at Allogene's CD19 Forum Demonstrated Six Month Complete Response (CR) Rate of 36% in CAR T Na?ve LBCL Patients Treated with ALLO-501 SOUTH SAN FRANCISCO, Calif., June 04, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T(tm)) therapies for cancer today presented data from multiple studies across lead anti-CD19 AlloCAR T therapy programs in two poster presentations at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting being held virtually June 4 -- 8, 2021. "Allogene is demonstrating that allogeneic CAR T has the potential to compete with autologous therapies, as well as expand the use of cell therapy by leveraging the unique benefits of an off-the-shelf product to treat every eligible patient," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene Therapeutics. "We are very pleased with the data presented at ASCO and our CD19 Forum and are increasingly confident in the path forward as we plan to initiate a potential pivotal trial for ALLO-501A in late 2021." The ASCO presentations include data from Phase 1 ALPHA (ALLO-501) and ALPHA2 (ALLO-501A) trials in relapsed/refractory non-Hodgkin lymphoma (NHL), developed in collaboration with Servier, and presented in the Developmental Therapeutics -- Immunotherapy session (Abstract #2529) by Frederick L. Locke, M.D., Co-Leader, Moffitt Immuno-Oncology Program, Vice Chair and Associate Member Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center. Safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from ALLO-647, a component of the Company's differentiated lymphodepletion regimen, will be presented in the same session (Abstract #2527) by Michael Tees, M.D., M.P.H., Associate Member Physician, Colorado Blood Cancer Institute, Sarah Cannon Research Institute. Due to the virtual nature of the meeting, the ASCO presentations were finalized in advance of Allogene's CD19 Forum on May 19, 2021. As such, data presented at the CD19 Forum, accessible via this link and included below, is more comprehensive and reflects information collected as of May 12, 2021 from the ALPHA and ALPHA2 studies. The Company intends to initiate a Phase 2 trial with ALLO-501A, pending regulatory feedback, by the end of 2021. The next clinical update on the CD19 program is planned for Q4 2021. Phase 1 ALLO-501 ALPHA Trial Data presented from the ALPHA trial supports the ability of a single administration of ALLO-501 to generate deep and durable responses at a rate that is similar to approved autologous CAR T therapies. As of the April 19, 2021 data cutoff, 42 patients were enrolled and 41 received ALLO-501, including nine who had previously received autologous CAR T treatment. The one patient not treated was enrolled but removed from the study prior to lymphodepletion due to lymphoma related obstructive kidney disease. In the trial, 98% of patients received ALLO-501 and the median and mean time from enrollment to the start of therapy was five days. Longest Ongoing CR at 15 Months in Both Large B Cell Lymphoma (LBCL) and Follicular Lymphoma (FL) Overall Response Rate (ORR) of 75% and CR Rate of 50% Across Histologies in CAR T Na?ve Patients on Par with Autologous CAR T Therapies 98% of Enrolled Patients Received ALLO-501 With a Median Time of 5 Days from Enrollment to Start of Therapy ALLO-501A Demonstrated Comparable Efficacy and Safety to ALLO-501 Consolidation Dosing was Well Tolerated and Shows Early Promise with Four Patients Converting from Partial Response (PR) to CR Following Second Dose of ALLO-501 or ALLO-501A No Dose Limiting Toxicities or Graft-vs-Host Disease; Limited Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Cytokine Release Syndrome (CRS) Initiation of a Potentially Pivotal Trial of ALLO-501A Expected by End of 2021; Next CD19 Program Clinical Update Planned for Late 2021