Foresight Diagnostics Launches PRECISE-HL Trial to Explore ctDNA-Based Therapy De-Escalation in Classical Hodgkin Lymphoma (cHL)

- The trial's goal is to assess reducing chemotherapy exposure for cHL patients who demonstrate an early response to treatment

BOULDER, Colo., March 5, 2025 /PRNewswire/ -- Foresight Diagnostics, which provides ultra-sensitive minimal residual disease (MRD) detection technology, today announced the launch of the PRECISE-HL clinical trial with the University of Washington School of Medicine and the Fred Hutch Cancer Center in Seattle.¹ The study will use Foresight CLARITY™ laboratory developed test (LDT), a circulating tumor DNA (ctDNA)-based MRD LDT, to investigate personalizing treatment for patients with advanced-stage classical Hodgkin lymphoma (cHL). The goal of the PRECISE-HL trial is to assess reducing chemotherapy exposure for patients who demonstrate early response to treatment.

Currently, the standard treatment for newly diagnosed advanced cHL patients involves several cycles of chemotherapy. Recent studies have explored combining new therapies, such as PD-1 inhibitors like nivolumab, with chemotherapy to potentially improve long-term outcomes.^2,3 Notably, research from the University of Washington School of Medicine demonstrated that over 70% of patients achieved undetectable MRD as early as the end of cycle 2, when treated with a combination of a PD-1 inhibitor plus chemotherapy regimen.⁴ Despite these promising results, current standard of care recommends patients to undergo prolonged chemotherapy, which can lead to long-term side effects.

"Building on two promising breakthroughs—the remarkably high rate of early response to combination immunochemotherapy and our ability to detect this response through ultra-sensitive ctDNA-MRD testing—we are now launching a prospective study to investigate whether we can safely reduce chemotherapy for these early responders while maintaining long-term efficacy," said Dr. Ryan Lynch, principal investigator of the study and associate professor at the University of Washington School of Medicine. "This approach has the potential to transform cHL treatment by personalizing therapy duration based on individual patient response, ultimately improving both outcomes and quality of life."

The PRECISE-HL trial will enroll patients with newly diagnosed advanced-stage cHL, who will receive two cycles of nivolumab + AVD therapy (doxorubicin, vinblastine, and dacarbazine). After an interim assessment using Foresight CLARITY™ LDT, patients with undetectable ctDNA will transition to nivolumab monotherapy for two cycles after completing only four cycles of nivolumab + AVD, while patients with detectable ctDNA will continue with the full six cycles of nivolumab + AVD. End of therapy ctDNA-MRD analysis will also be an exploratory endpoint for the trial.

"The PRECISE-HL trial represents a significant milestone in our pursuit of using MRD to personalize therapy for patients. This study complements the SHORTEN-ctDNA trial in diffuse large B-cell lymphoma (DLBCL), that Foresight Diagnostics is also supporting, in seeking to reduce patient exposure to chemotherapy," said Dr. David Kurtz, Chief Medical Officer and Head of Research at Foresight Diagnostics. "Foresight CLARITY™ LDT with ultra-sensitive MRD detection capabilities helps overcome the limitations of traditional response assessment methods like PET/CT, which can yield false positives and negatives in cHL. The performance of the Foresight CLARITY™ technology enables us to research more personalized treatment approaches that were previously not feasible. We are excited to collaborate with the University of Washington and Fred Hutch on this innovative trial that could fundamentally change how we approach cHL treatment."

For more information about the PRECISE-HL study, including eligibility and detailed protocol, please visit the trial overview page on ClinicalTrials.gov.

References:

¹ PRECISE-HL: Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation in Advanced Hodgkin Lymphoma

² Herrera, Alex F et al. "Nivolumab+AVD in Advanced-Stage Classic Hodgkin's Lymphoma." The New England journal of medicine vol. 391,15 (2024): 1379-1389. doi:10.1056/NEJMoa2405888

³ Lynch, Ryan C et al. "Concurrent pembrolizumab with AVD for untreated classic Hodgkin lymphoma." Blood vol. 141,21 (2023): 2576-2586. doi:10.1182/blood.2022019254

⁴ Lynch, Ryan C et al. "High Rates of Undetectable MRD By Phased-Seq on Interim and End of Treatment Timepoints in Untreated Advanced Stage Chl Treated with Pembrolizumab + AVD." Blood 2024; 144 (Supplement 1): 3051. doi: https://doi.org/10.1182/blood-2024-206512

About Foresight Diagnostics

Foresight Diagnostics is a privately held cancer diagnostics company and CLIA-certified laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million. The improved sensitivity of Foresight CLARITY™ has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on X, LinkedIn, and Bluesky. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

SOURCE Foresight Diagnostics, Inc.