WINTHER trial seeks to select rational therapeutics based on analysis of tumor without DNA structural changes

PARIS – WINTHER, the first global clinical trial conducted by the WIN Consortium, is designed to fulfill the promise of personalized cancer care to the more than 60% of patients whose tumor has no DNA structural change, according to the trial’s principal investigator.

The WINTHER trial seeks to go beyond the current practice of selection of treatment based upon biopsy and histology of a solid tumor, said Jean-Charles Soria, MD, PhD, from the Institute Gustave Roussy at the WIN 2013 Symposium here.

The trial will be conducted at 6 academic cancer centers: MD Anderson, Institute Gustave Roussy, Hospital Vall d’Hebron, Chaim Sheba Medical Center, McGill Segal Cancer Center and University of California, San Diego Moores Cancer Center.

Jean-Charles Soria

“We have to admit that only 30% to 40% of patients have relevant structural DNA change so WINTHER is trying to address the question of how can we improve patient care for the 60% to 70% of patients that were offered the dream of precision medicine but have no structural DNA changes,” Soria said.

WINTHER will use a state-of-the art approach that will use dual biopsies – tumor and normal matched tissue from the same patient, Soria said. The trial will also investigate RNA and microRNAs for those patients who do not have an actionable DNA alteration. The goal is to assess the genetic distance between normal and tumor tissue.

“What we are going to use is this genetic distance to convert it into specific drug scoring to try in the 60% of patients without structural DNA changes a biologically rational selection of the therapy,” Soria said. The scoring system can estimate the response to existing treatments on the market (standard or targeted, expensive or not) for a given patient. This complex bioinformatics tool integrates all known data on biomarkers, molecular aberrations, targeted or non-targeted therapies, predictive algorithms of efficacy, according to the WIN Consortium website.

The trial will enroll 200 patients with metastatic cancer. Arm A will have 80 patients matched with existing targeted therapies (20 patients with labeled targeted therapies and 60 patients with targeted therapies). Arm B will have 120 patients (20 patients with standard of care and 100 patients with off label drugs).

Soria described the initial few months of enrollment.

“WINTHER is no longer a dream. It is a reality. It is enrolling. It is recruiting,” Soria said. – by Joan-Marie Stiglich

Disclosure: Soria has no relevant financial disclosures. The WINTHER trial is funded by Pfizer, Novartis, EU FP7 European Health Directorate and the National Breast Cancer Foundation, Inc.

For more information:

Soria JC. #L3.06. Presented at: WIN 2103 Symposium; July 10-12, 2013; Paris, France.