Allogene Therapeutics Inc. and Foresight Diagnostics (Foresight) announced a strategic partnership to develop a minimal residual disease (MRD) in-vitro diagnostic (IVD) to determine eligibility in ALPHA3, the first pivotal trial for first line (1L) consolidation treatment of large B-cell lymphoma (LBCL). The ALPHA3 trial uses Foresight?s investigational PhasED-Seq? ctDNA-MRD platform to identify patients with MRD after 1L treatment for LBCL.

The study will evaluate whether such patients benefit from consolidation with cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A). If successful, cema-cel could become part of the 1L treatment plan for newly diagnosed LBCL patients who are at a high risk for recurrence. Start-up activities for the ALPHA3 trial have been initiated.

Although 1L R-CHOP is curative for many with LBCL, approximately 30% of patients who initially respond will later relapse. The standard of care after 1L treatment has been simply to ?watch and wait? for the disease to relapse.

The reliance on radiographic imaging, the current clinical standard for relapse detection, does not allow effective consolidation approaches due to its limited accuracy. PhasED-Seq is an ultra-sensitive and specific, plasma-based liquid biopsy that will enable cema-cel?s 1L consolidation approach in ALPHA3 through early and accurate MRD assessment beyond current radiographic imaging-based disease assessment. Growing evidence also suggests improved outcomes and safety for patients who are treated with CAR T when tumor burden is low.

Cema-cel?s Phase 1 safety profile, with low rates of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), already permits its use in the outpatient setting in relapsed/refractory patients and may further improve in patients with no radiological evidence of disease.