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Cruising along with companion diagnostics
SALT LAKE CITY—The second quarter of 2015 has been a busy period for Myriad as it continues advancing a number of its diagnostic tests in various indications. As April kicked off, Myriad expanded its companion diagnostic collaboration with AstraZeneca, which has been running for several years. Per the expanded agreement terms, the companies will use Myriad’s BRACAnalysis CDx to prospectively identify patients with metastatic pancreatic cancer who may respond to treatment with AstraZeneca’s Lynparza (olaparib), a poly-ADP ribose polymerase (PARP) inhibitor. BRACAnalysis CDx is an in-vitro diagnostic device that enables 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.
This past December, BRACAnalysis CDx received U.S. Food and Drug Administration (FDA) approval to identify ovarian cancer patients with germline mutations in BRCA1/2 who might be candidates for treatment with Lynparza, marking the first time the FDA has approved a complex laboratory developed test (LDT) under the premarket approval application process and the first-ever approval of an LDT companion diagnostic test.
Concurrently, the FDA also approved Lynparza capsules as the first monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have received treatment with three or more prior lines of chemotherapy. It was the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer as detected by BRACAnalysis CDx.
“Pancreatic cancer is one of the few cancers for which survival has not improved substantially in the last 40 years, and the average life expectancy after diagnosis with metastatic disease is three to six months,” Mark Capone, president of Myriad Genetic Laboratories, noted in a statement. “Our collaboration with AstraZeneca is a big step forward in the fight against pancreatic cancer and in ensuring that personalized medicine becomes reality. BRACAnalysis CDx has the potential to quickly and accurately identify those patients who may be candidates for treatment with Lynparza and hopefully to accelerate better health outcomes.”
In March, the company expanded another agreement testing one of its products as a companion diagnostic to a PARP inhibitor. Myriad and BioMarin Pharmaceutical Inc. expanded their collaboration to evaluate the myChoice HRD companion diagnostic test to prospectively identify patients with metastatic, ovarian and possibly other tumor types that might be sensitive to talazoparib, an investigational PARP inhibitor. Myriad and BioMarin will also work together under FDA guidelines and regulations for the development and regulatory approval requirements for both talazoparib and myChoice HRD. The myChoice HRD is the first homologous recombination deficiency test capable of detecting when a tumor loses the ability to repair double-stranded DNA breaks, which results in an increased susceptibility to DNA-damaging drugs such as PARP inhibitors or platinum drugs.
The expansion builds off an ongoing collaboration launched in September 2013, when BioMarin started using the BRACAnalysis CDx test in its pivotal Phase 3 EMBRACA and Phase 2 ABRAZO clinical studies of talazoparib for advanced or metastatic breast cancer patients with BRCA mutations.
March also saw the 30th Annual Congress of the European Association of Urology, at which Myriad shared results from its EMPATHY-P clinical study of Prolaris in patients recently diagnosed with prostate cancer. Prolaris is a novel 46-gene RNA-expression test that can directly measure tumor cell growth characteristics to stratify the risk of disease progression in prostate cancer patients. It offers a quantitative measure of the RNA expression levels of genes involved in tumor growth progression.
The EMPATHY-P study, which evaluated the test on 525 patient biopsy samples from newly diagnosed patients from Italy, Germany, Spain, Switzerland and the United Kingdom, compared the Prolaris test results against the results of standard clinical pathology methods (D’Amico/AUA risk stratification) in determining cancer aggressiveness. Overall, the data showed that the Prolaris test found 51.6 percent of the men evaluated had a risk profile that was either higher or lower than what would be expected using clinical pathology, a finding that was consistent with that of the previously published U.S. Prostate Biopsy Research study, which found 51 percent of U.S. patients presented with a risk profile different from clinical pathology. The study showed that the Prolaris test score found 22 percent of the EMPATHY-P patients had less aggressive cancer and 20 percent had more aggressive cancer compared to standard clinical pathology measurements.
May saw Myriad taking its efforts online as the company launched a digital media campaign to increase public awareness of companion diagnostics’ role in personalized and precision medicine. The campaign features doctors, patients and Myriad employees, and can be accessed online by visiting http://bit.ly/1Apm8nq or by following the hashtags #personalizedmedicine, #precisionmedicine and/or #companiondiagnostics.
“Cancer is a complex array of diseases, and there should not be a one-size-fits-all approach to treatment. Companion diagnostic tests provide us with insights into a patient’s individual biology, and that knowledge is power,” said Ron Rogers, executive vice president of corporate communications at Myriad. “Personalized medicine is a game-changer; it’s the future of medicine. Our goal is to ensure that patients are getting the right drug at the right time and to avoid the trial-and-error treatment paradigm.”