NEW YORK – Nonprofit organization Friends of Cancer Research (Friends) on Wednesday unveiled a new public-private research partnership to harmonize the use of homologous recombination deficiency (HRD) as a biomarker to guide certain treatment types in cancer patients.
Currently, there is no standardized way to define, measure, and report HRD, a complex biomarker that has shown promise in identifying patients with certain cancers who are more likely to benefit from PARP inhibitors and drugs in development that target cells with DNA repair defects.
To address this, Friends has assembled a consortium of project partners to address concerns about the lack of consistency in determining HRD status, its prognostic value, and its use as a predictive biomarker.
The project will comprise three phases. Phase 1, currently underway, will aim to more accurately define HRD and the parameters that contribute to determining HRD status, Friends said. The consortium also hopes to create recommendations and best practices for the entire cancer community by the end of this phase, which is scheduled to wrap up in the first quarter of 2021.
Partners participating in phase 1 of the project include Abbvie, Ambry Genetics, AstraZeneca, Arizona State University, Bristol Myers Squibb, Caris Life Sciences, EMD Serono, Foundation Medicine, GlaxoSmithKline, Guardant Health, Janssen, Merck, Myriad Genetics, the National Cancer Institute, Novartis, Pfizer, Resolution Biosciences, Tempus, Thermo Fisher Scientific, University of Alabama at Birmingham, University of Heidelberg, and the US Food and Drug Administration.
"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," Rebecca Arend, associate professor at the University of Alabama at Birmingham, said in a statement. "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."
Friends of Cancer Research previously spearheaded a similar consortium to standardize the assessment of tumor mutational burden, a project that has thus far yielded a TMB calibration tool that developers of next-generation sequencing assays can use to correct variability in how TMB is calculated across gene panels and analysis pipelines.