#USA #Boulder #Foresight Diagnostics #Hodgkin Lymphoma #ctDNA

Foresight Diagnostics' Innovative PRECISE-HL Trial

Foresight Diagnostics has officially launched a groundbreaking clinical trial named PRECISE-HL, in collaboration with the University of Washington School of Medicine and the Fred Hutch Cancer Center, aimed at revolutionizing the treatment protocols for advanced-stage classical Hodgkin lymphoma (cHL). This trial represents a significant shift in how chemotherapy may be administered to patients, particularly those who exhibit an early positive response to treatment. By implementing an ultra-sensitive minimal residual disease (MRD) detection technology that relies on circulating tumor DNA (ctDNA), Foresight seeks to personalize therapy, limiting unnecessary chemotherapy exposure.

The Need for Change

Currently, the standard of care for newly diagnosed advanced cHL patients involves multiple cycles of chemotherapy. However, recent studies suggest that combining innovative therapies, like PD-1 inhibitors, with traditional chemotherapy can yield better outcomes. Notably, research from the University of Washington found that more than 70% of patients achieved undetectable MRD by the end of the second chemotherapy cycle when treated with a combination of PD-1 inhibitors and standard chemotherapy.

Despite these promising results, the current treatment protocol often mandates patients to undergo extended chemotherapy courses, which can lead to significant long-term side effects.

Trial Goals

The PRECISE-HL trial aims to determine whether it is feasible to reduce the amount of chemotherapy administered to patients who have shown an early positive response to treatment. Dr. Ryan Lynch, the principal investigator of the study, emphasized the transformative potential of this study. The goal is not only to enhance patient outcomes but also to improve their quality of life.

The trial will enroll patients diagnosed with advanced-stage cHL, and will administer two cycles of a therapy combining nivolumab and AVD (doxorubicin, vinblastine, and dacarbazine). After this treatment, an interim assessment will be made using Foresight’s CLARITY LDT. Patients showing undetectable ctDNA levels will shift to a treatment regime that includes just two more cycles of nivolumab monotherapy post the initial four cycles, whereas those with detectable ctDNA will continue with the full regimen of six cycles.

Transformative Potential

Dr. David Kurtz, Chief Medical Officer at Foresight Diagnostics, pointed out the significance of the PRECISE-HL trial in the broader context of patient care. He noted how this initiative extends the company’s commitment to employing MRD as a method to tailor patient therapy, similar to efforts underway in the SHORTEN-ctDNA trial focused on diffuse large B-cell lymphoma.

The innovative technology utilized in the Foresight CLARITY test is expected to overcome some limitations observed with traditional assessment methods like PET/CT scans, which may sometimes yield inaccurate results.

By collaborating with reputable institutions like the University of Washington and Fred Hutch, Foresight aims to pave the way for a new era in cHL management, where treatment protocols can be highly individualized and based on precise biological responses rather than one-size-fits-all approaches.

The research is a promising step forward, emphasizing the importance of personalized medicine in cancer treatment. As this trial progresses, it could lead the way in redefining how we view and conduct treatment for patients battling classical Hodgkin lymphoma, ultimately aiming for safer, more effective, and more humane cancer care.

For detailed information about the PRECISE-HL study, including eligibility criteria and the full protocol, interested parties are encouraged to visit the trial overview page on ClinicalTrials.gov.