Allogene Therapeutics Initiates Pivotal Phase 2 Trial Investigating Cemacabtagene Ansegedleucel (cema-cel), an Allogeneic CAR T Product, as Part of First Line Treatment for Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse

• ALPHA3 Trial Has the Potential to Position Cema-cel as Part of First Line (1L) Treatment for LBCL to Improve Cure Rates
• First Prospective Trial to Incorporate the Foresight Diagnostics’s Investigational CLARITY^™ Test to Identify Patients with LBCL Who Have Minimal Residual Disease (MRD) and are Likely to Relapse Following Standard 1L Treatment
• Unique Profile of Investigational AlloCAR T™ Products May Expand Access to CAR T within Community Cancer Centers where Most 1L Patients are Managed
• ALPHA3 Expected to Complete Enrollment in 1H 2026; BLA Submission Anticipated in 2027

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif. and BOULDER, Colo., June 20, 2024 (GLOBE NEWSWIRE) — Allogene Therapeutics Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T^™) products, and Foresight Diagnostics (Foresight), a leader in ultra-sensitive liquid biopsy-based minimal residual disease (MRD) detection, today announced the initiation of the pivotal Phase 2 ALPHA3 trial evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) treatment regimen for newly diagnosed LBCL patients who are likely to relapse after standard 1L treatment and need further therapy.

“The transformative impact that the ALPHA3 trial could have on the treatment of first line LBCL is hard to overstate,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “Our investigational allogeneic CAR T product is designed to eliminate the complex logistics that have hindered autologous CAR T adoption to date and open the door for access by doctors in the community setting. ALPHA3 will proactively offer this potentially curative modality only to those patients who are likely to relapse.”

The ALPHA3 trial will screen patients who are likely to relapse after 1L treatment for enrollment in the trial by using the Foresight CLARITY^™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq^™, which recently received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). Leveraging CLARITY’s ultra-sensitive MRD technology, cema-cel will be administered as a one-time infusion immediately upon detection of MRD at the completion of six cycles of R-CHOP or other standard 1L chemoimmunotherapy regimen.

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