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Allogene Therapeutics Announces ALPHA3 Trial-in-Progress Poster Presentation at ASH Annual Meeting
Globenewswire· 2025-11-03 14:04
Core Insights - Allogene Therapeutics is presenting a Trial-in-Progress poster for the pivotal Phase 2 ALPHA3 trial evaluating cemacabtagene ansegedleucel (cema-cel) at the 2025 ASH Annual Meeting [1][2] Group 1: ALPHA3 Trial Overview - The ALPHA3 trial is a randomized study comparing cema-cel administered after standard FC lymphodepletion versus observation, the current standard of care [2] - The trial focuses on patients with large B-cell lymphoma (LBCL) who remain minimal residual disease (MRD) positive after first-line chemoimmunotherapy [2][3] - A futility analysis comparing MRD conversion between the two arms is expected in the first half of 2026 [3] Group 2: Cema-cel Product Details - Cema-cel is an investigational, next-generation anti-CD19 AlloCAR T product designed for immediate administration upon MRD detection [3][5] - The product received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA in June 2022 for r/r LBCL [5] - Allogene holds oncology rights to cema-cel in the US, EU, and UK, with options for rights in China and Japan [5] Group 3: Market Context - Over 60,000 patients are expected to be treated for LBCL annually in the US, EU, and UK [6] - Approximately 30% of patients who initially respond to first-line treatment will relapse, necessitating subsequent treatment [6] - The ALPHA3 trial positions cema-cel as a potential "7th cycle" of frontline treatment for eligible patients with MRD [6] Group 4: Company Background - Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic CAR T products for cancer and autoimmune diseases [7] - The company aims to provide readily available cell therapy on-demand, more reliably, and at greater scale [7]