NEW YORK – Foresight Diagnostics on Wednesday said it is partnering with the University of Washington School of Medicine and the Fred Hutch Cancer Center to evaluate whether its Clarity minimal residual disease (MRD) test can be used to reduce chemotherapy exposure in some advanced Hodgkin lymphoma patients.
Patients newly diagnosed with Hodgkin lymphoma receive chemotherapy as part of standard treatment, and researchers are exploring whether adding PD-1 inhibitors such as Bristol Myers Squibb's Opdivo (nivolumab) enhances outcomes. In the Phase II PRECISE-HL trial, researchers will use Clarity, a circulating tumor DNA (ctDNA) test, to assess MRD in patients after two cycles of Opdivo and chemo. Those with undetectable ctDNA will transition to Opdivo monotherapy after completing a total of four cycles of combination therapy. Patients with detectable ctDNA will complete a full six cycles of Opdivo and chemo.
To be eligible for the trial, patients must have classical stage 3 or stage 4 Hodgkin lymphoma and must not have had prior systemic therapy, other than corticosteroids for symptom relief. Researchers are primarily interested in whether they can safety reduce chemo for early responders based on MRD negativity without impacting progression-free survival. They will also evaluate progression-free survival in MRD-positive patients after two cycles of treatment, progression-free survival across both cohorts, and patients' best responses. Investigators will further assess patients' MRD at the end of therapy as an exploratory endpoint.
"This [MRD] approach has the potential to transform [classic Hodgkin lymphoma] treatment by personalizing therapy duration based on individual patient response, ultimately improving both outcomes and quality of life," Ryan Lynch, principal investigator of the study and associate professor at the University of Washington School of Medicine, said in a statement.
Foresight is also evaluating the ability of Clarity to personalize therapy in the SHORTEN-ctDNA trial in diffuse large B-cell lymphoma and in large B-cell lymphoma in Allogene Therapeutics' ALPHA3 trial. These studies are part of a series of trials the Boulder, Colorado-based company has launched to demonstrate clinical utility of the Clarity assay.