Myriad Genetics, Salt Lake City, says a new study demonstrates that men with metastatic castration-resistant prostate cancer (mCRPC) lived for a longer time without disease progression when treated with AstraZeneca’s Lynparza (olaparib) than similar prostate cancer patients who were not treated with the novel poly ADP ribose polymerase (PARP) inhibitor. The AstraZeneca/Merck Phase III Profound study involved men with mCRPC cancer selected for BRCA1/2 or ATM gene mutations, a subpopulation of homologous recombination repair mutations.
Myriad will file a supplementary premarket approval application with FDA to authorize the company’s BRACAnalysis CDx as a companion diagnostic test for olaparib in mCRPC patients with germline BRCA mutations.
BRACAnalysis CDx is an in vitro diagnostic intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in ethylenediaminetetraacetic acid (EDTA).
“The Profound trial confirmed the potential benefits of using biomarkers to help guide care for men with metastatic castration-resistant prostate cancer,” says Johnathan Lancaster, MD, PhD, chief medical officer at Myriad Genetics. “This study is another example of Myriad’s commitment to help our pharmaceutical partners achieve and deliver precision medicine for people with cancer.”
The results are the first reported clinical outcomes from the Profound study, which assessed the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in mCRPC subjects who have failed prior treatment with a new hormonal agent and who have homologous recombination repair gene mutations. The results demonstrated a statistically significant and clinically meaningful improvement of radiographic progression-free survival among patients selected for mutations in BRCA1/2 or ATM and treated with olaparib.
According to estimates, more than 170,000 men are diagnosed annually with prostate cancer, which is the second leading cause of death by cancer in men. An estimated 31,620 men will die from the disease in 2019. The 2019 guidelines from the National Comprehensive Cancer Network (NCCN) state that germline BRCA mutations should be tested in all newly diagnosed men with high-risk, very high-risk, regional, or metastatic prostate cancer.
For more information visit Myriad Genetics.