In search of HRD harmony

WASHINGTON—Cancer biomarkers and companion diagnostics are key in the fight against cancer, both to diagnose the disease earlier and to identify the optimal treatments for each patient. And the nonprofit Friends of Cancer Research (Friends) is aiming to add a new tool to oncologists' portfolios with the establishment of the HRD Harmonization Project. This research partnership seeks to realize the potential of homologous recombination deficiency (HRD), a biomarker that could identify patients likely to benefit from PARP inhibitors and DNA repair-targeting drugs but that lacks standardized methods of measurement.

The initiative brings together members from across the industry, with Phase 1 of the project consisting of the following organizations: Abbvie, Ambry Genetics, AstraZeneca, Arizona State University, Bristol Myers Squibb, Caris Life Sciences, EMD Serono, Foundation Medicine, GlaxoSmithKline, Guardant Health, Janssen, Merck, Myriad, the National Cancer Institute, Novartis, Pfizer, Resolution Biosciences, Tempus, Thermo Fisher, University of Alabama at Birmingham, University of Heidelberg, and the FDA. 

“Harmonization regarding measurement and use of HRD as a predictive biomarker will help ensure patients receive the best treatment for him or her,” said Friends of Cancer Research President and CEO Jeff Allen. “Without greater alignment to defining and measuring HRD, there will continue to be confusion around its use in the clinic and its role in drug development, potentially leading to less-favorable results for patients.”

“Understanding what exactly HRD is, how to accurately assess and measure the degree of HRD in a tumor, and how this affects outcomes or response to treatment in patients continues to be confusing to clinicians, patients and researchers,” added Rebecca C. Arend, associate professor at the University of Alabama at Birmingham. “Therefore, a project that is as non-biased as possible in breaking down the silos between diagnostic companies and drug companies in order to better understand and define HRD is extremely important.”

HRD is linked with better patient response to treatments, specifically PARP inhibitors and platinum-based chemotherapy. The partners will seek to address the inconsistencies in determining HRD status and its use as a prognostic biomarker in three phases, with the first phase—already underway—consisting of a landscape analysis of current HRD approaches. By the end of this phase, the goal is to have established a definition for HRD and parameters for determining HRD-positive or -negative status. Results are expected in Q1 2021.

“Foundation Medicine is committed to providing reliable insights to inform treatment decisions for cancer patients, which requires deep collaboration throughout the ecosystem and consistent, high-quality standards across cancer care,” Jeffrey Venstrom, senior vice president of Clinical Development at Foundation Medicine, commented in a press release. “We are excited to partner with Friends of Cancer Research, the FDA, and the cross-industry group on this important HRD effort, which will fundamentally help us ensure that the right patient is receiving the right therapy at the right time.”