Foresight Diagnostics announces publication of landmark study demonstrating prognostic value of ultrasensitive ctDNA-MRD detection in large B-cell lymphoma
Foresight Diagnostics announced the publication of a landmark pooled analysis in the Journal of Clinical Oncology demonstrating that MRD analysis using Foresight CLARITY at end of therapy provided greater prognostic accuracy than PET/CT in large B-cell lymphoma (LBCL).
The findings highlight the potential of ultrasensitive MRD testing as a robust and reliable tool for remission assessment following frontline treatment.
The study integrated data from five prospective clinical studies and included 137 patients treated with curative-intent chemotherapy. MRD was measured using the Foresight CLARITY assay, which leverages PhasED-Seq.
Key findings from the study include:
ctDNA-MRD assessment was prognostic as early as after two cycles of frontline chemotherapy. Patients with undetectable MRD after 2 cycles achieved a 2-year progression-free survival (PFS) of 96% compared to 67% for patients with detectable MRD (hazard ratio 6.9; p=0.0025).
ctDNA-MRD assessment was most prognostic at end of therapy: 78% of patients were MRD-negative and had a 2-year PFS of 97%, compared to just 29% among MRD-positive patients (hazard ratio 28.7; p<0.0001). By comparison, PET/CT status at end of therapy was less predictive, with a hazard ratio of 3.6.
MRD status further stratified risk within both PET-negative and PET-positive groups at end of therapy. Patients with detectable MRD faced a higher risk of relapse even if their imaging was negative. Conversely, PET-positive patients with undetectable MRD had significantly better outcomes than patients with both positive imaging and MRD results.
Overall, Foresight CLARITY demonstrated 86% clinical sensitivity for relapse detection and 91% clinical specificity for remission at end of therapy, based on a median follow-up of 37 months.
The full manuscript, titled “Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma,” is available online in the Journal of Clinical Oncology.
