NEW YORK – Allogene Therapeutics and Foresight Diagnostics on Thursday said they will partner to develop an in vitro diagnostic test to select patients with minimal residual disease (MRD) after first-line consolidation therapy for a Phase II clinical trial of its anti-CD19 CAR T-cell therapy cemacabtagene ansegedleucel (cema-cel) in large B-cell lymphoma (LBCL).
San Francisco-based Allogene is currently studying cema-cel (formerly ALLO-501A) with its anti-CD52 monoclonal antibody ALLO-647 in a Phase I/II trial, dubbed ALPHA2, as a treatment for patients with relapsed or refractory LBCL after a standard lymphodepletion therapy regimen. In results from the trial that were reported in June 2023, seven of 12 patients, or 58 percent, receiving the Phase II therapy regimen achieved a complete response, and five out of 12, or 42 percent, had a complete response at six months after beginning treatment. The median duration of response was 23.1 months.
The firms now plan to use Foresight's PhasED-Seq ctDNA-MRD platform to identify patients with MRD in a new Phase II trial, ALPHA3, which is expected to begin in mid-2024. In this study, researchers will evaluate the potential benefits of cema-cel as a consolidation therapy for patients with newly diagnosed LBCL who are at high risk of recurrence.
About 30 percent of patients with LBCL who receive first-line chemotherapy will relapse, and the standard of care for those patients is to monitor for recurrence with radiographic imaging. Allogene and Foresight hope that patient outcomes will be improved through earlier detection of relapses by PhasED-Seq MRD testing and prompt consolidation therapy with cema-cel.
"Although CAR T therapy has shown promise in multiple cancer indications, it has been relegated to later lines of treatment," Zachary Roberts, Allogene executive VP of R&D and chief medical officer, said in a statement. "The combination of cema-cel's speed to treatment, its favorable efficacy and safety profile from the Phase I trial in later lines, and ability to pair it with an accurate biomarker has provided the pathway to introduce CAR T into the first-line LBCL treatment setting."