Allogene Therapeutics Activates Three Community Cancer Centers as First Sites for the Pivotal Phase 2 ALPHA3 Trial Evaluating Cemacabtagene Ansegedleucel (cema-cel) as First Line (1L) Consolidation Treatment for Patients with Large B-Cell Lymphoma (LBCL)

• Patient Screening is Underway at Rocky Mountain Cancer Centers, Part of the US Oncology Network and Sarah Cannon Research Institute; Astera Cancer Care, Part of the OneOncology Network; and Norton Cancer Institute
• ALPHA3 Will be the First Pivotal Trial to Offer CAR T as Part of First Line (1L) Treatment at Community Cancer Centers, Where 80% of Patients Receive Care
• ALPHA3 Expected to Complete Enrollment in 1H 2026; Potential BLA Submission in 2027

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., July 01, 2024 (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 that Rocky Mountain Cancer Centers (RMCC), part of the US Oncology Network and Sarah Cannon Research Institute (SCRI); Astera Cancer Care (ACC), a multi-specialty community oncology practice and part of the OneOncology network; and Norton Cancer Institute, are open for enrollment in the pivotal Phase 2 ALPHA3 trial.

The ALPHA3 trial is evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) consolidation treatment regimen for newly diagnosed and treated large B-cell lymphoma (LBCL) patients who remain positive for minimal residual disease (MRD). Detection of MRD will be done using the Foresight CLARITY^™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq^™. When given as a “7^th cycle” of frontline treatment to eligible patients with MRD, consolidation treatment with cema-cel has the potential to meaningfully improve 1L cure rates for patients with LBCL who are likely to relapse.

“We believe community physicians have been waiting for a trial like ALPHA3 that offers cutting-edge CAR T without the inherent complexities associated with autologous therapies,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “The differentiated attributes of cema-cel eliminate many of the complex logistics that have hindered CAR T adoption in the community setting. The fact that community-based practices are the first sites to open for enrollment in the ALPHA3 trial is a significant symbolic step forward in expanding patient access to this powerful modality and will serve as a catalyst for our cema-cel development program.”

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