SALT LAKE CITY—Myriad Genetics Inc. and AbbVie Inc. have signed an expanded companion diagnostic agreement to use Myriad’s Tumor BRACAnalysis CDx as a companion diagnostic to support AbbVie’s veliparib, a novel poly (ADP-ribose) polymerase, or PARP, inhibitor being developed to treat brain metastasis and other cancers. This expands on the companies’ previous agreements, in which Myriad is providing BRACAnalysis CDx testing to support a number of AbbVie’s ongoing Phase 3 clinical studies of veliparib, including neo-adjuvant and metastatic breast cancer.
Myriad’s Tumor BRACAnalysis CDx is a companion diagnostic test for the identification of both germline (hereditary) and somatic (tumor) cancer-causing mutations in the BRCA1 and BRCA2 genes. The test has been shown to identify up to 50 percent more patients with cancer-causing BRCA 1/2 mutations when compared to germline testing alone.
“Myriad’s goal is to provide best-in-class patient care, and we believe that Tumor BRACAnalysis CDx will help us deliver on this goal by identifying patients who may respond to breakthrough therapies currently in development,” said Peter Meldrum, president and CEO of Myriad. “We are excited to expand our collaboration with AbbVie, an emerging leader in oncology, and believe their choice of Myriad as a commercial partner speaks to our unique ability to provide high-quality, high-value companion diagnostic testing on a global basis.”
In September, Myriad presented a study at the 2014 European Society for Medical Oncology annual meeting regarding the effectiveness of Tumor BRACAnalysis CDx in women with ovarian cancer. In the study, which consisted of 131 previously untreated women with high-grade ovarian cancer, blood samples were tested for germline BRCA mutations, and tumor samples obtained during surgery were tested for both somatic and germline BRCA mutations. The Tumor BRACAnalysis CDx test identified 28.3 percent of women with germline or somatic BRCA 1/2 mutations, while blood germline testing only identified the 19.6 percent of patients with germline BRCA 1/2 mutations. The somatic mutations identified by Myriad’s test represent a 44-percent increase in the detection of cancer-causing BRCA mutations over germline testing.
On Oct. 24, the company announced the establishment of a Tumor BRACAnalysis CDx laboratory in Europe. The test will be available throughout Europe, with testing conducted in Myriad’s laboratories in Munich, Germany.
Myriad is also advancing usage of its diagnostic test for melanoma; myPath Melanoma is a clinically validated gene expression test that looks at 23 genes to differentiate malignant melanoma from benign nevi across all major melanoma subtypes, with greater than 90-percent accuracy. At the 2014 American Society of Dermatopathology annual meeting in November, dermatopathologists were asked to diagnose and recommend treatment for 218 patients with pigmented skin lesions considered to be hard to diagnose. Before receiving the results of the myPath test, the doctors diagnosed 10.6 percent of the cases to be benign, 9.2 percent to be malignant and offered indeterminate diagnoses on 80.3 percent of the cases. After receiving the test results, the indeterminate diagnoses dropped to 37.6 percent, with benign diagnoses increasing to 40.8 percent and malignant diagnoses to 21.6 percent.
The results also affected the dermatopathologists’ treatment recommendations, with alterations seen in 49.1 percent of cases; in 39.4 percent of cases in which patients received a benign test results, the recommendations were downgraded to less-invasive treatment, while in 45.8 percent of cases who had malignant test results, treatment plans were upgraded to a more invasive approach.
This follows data released in September, when Myriad presented results from a pivotal clinical utility study of the test at the 2014 annual meeting of the College of American Pathologists. The analysis consisted of 687 cases of pigmented skin lesions, and expert dermatopathologists were asked for their diagnosis, level of confidence and recommendations for treatment for the cases before and after receiving the myPath test results. After the test results were provided, the dermatopathologists revised their treatment recommendations in 35 percent of cases, and the results led to a 76-percent reduction in indeterminate diagnoses.
“This clinical utility study demonstrates how the myPath Melanoma test can be successfully incorporated into clinical care to improve the treatment of malignant melanoma,” said Dr. Loren Clarke, vice president of medical affairs at Myriad Genetic Laboratories, in a statement regarding the results. “Myriad myPath Melanoma provides objective information to answer an important clinical question: Does my patient have a melanoma that requires surgery or medical intervention or is the lesion a harmless mole that needs to be watched?”
Myriad announced another CDx-focused collaboration on Nov. 20, in which TESARO Inc. will use Myriad’s myChoice HRD companion diagnostic to identify tumor tissue with a deficiency in homologous recombination. This will help to broaden the target population for potential responders to niraparib, a PARP inhibitor that TESARO is advancing in ovarian cancer, BRCA-positive breast cancer and Ewing’s sarcoma. Per the collaboration, Myriad will provide testing services and pursue necessary regulatory approval to support niraparib’s development. Myriad recently shared new data that showed that the myChoice HRD score is predictive of niraparib sensitivity in patient-derived xenograft models of ovarian cancer.