NEW YORK (GenomeWeb) – Myriad Genetics is gearing up for a major commercialization push for BRACAnalysis CDx after gaining regulatory approval in the metastatic breast cancer setting and is working to expand reimbursement for the Vectra DA and GeneSight tests.
The company provided an update on its effort to grow adoption of its products during a call to discuss second quarter financial results of its fiscal year 2018. During that period, molecular diagnostics revenues declined 3 percent to $179.2 million, from $183.9 million a year ago.
The reduction was largely due to a 12 percent decrease in MyRisk Hereditary Cancer test revenues ($126.9 million), though Myriad is hoping to bolster its hereditary cancer franchise with the recently launched 86-SNP breast cancer risk test, called Riskscore. The company presented the full validation data for Riskscore at the San Antonio Breast Cancer Symposium in December and showed that 38 percent of patients had a greater than 20 percent lifetime risk for the disease, the threshold at which guidelines recommend MRI screening in addition to mammography.
Although Myriad didn't break out specific adoption figures for Riskscore, CEO Mark Capone suggested during the call that there was strong interest in the test and noted that preventive care year-over-year volume trends accelerated during Q2.
Prostate cancer risk testing is another area where Myriad will likely focus on growing adoption of MyRisk, since the National Comprehensive Cancer Network in September recommended hereditary cancer testing for all patients with metastatic prostate cancer in updated guidelines. "We're seeing a significant increase in hereditary cancer testing among prostate cancer patients," Capone said, noting that over the last year, the company has seen a 10-fold increase in testing volume in this segment.
Today, the company announced top-line results from a study using the 28-gene MyRisk test to evaluate more than 1,100 men with a personal history of prostate cancer and found that around 12 percent harbored one or more hereditary cancer risk mutations in well-known genes, such as BRCA1 and BRCA2, and other cancer-associated genes.
"As one of the largest studies of hereditary cancer risk assessment ever conducted in prostate cancer, our MyRisk Hereditary Cancer test demonstrated that roughly the same percentage of men with prostate cancer carry hereditary cancer-causing mutations as do women with breast cancer," Johnathan Lancaster, Myriad's chief medical officer, said in a statement. He noted that men with hereditary cancer risk mutations may benefit from active surveillance to screen for secondary cancers, treatment with PARP inhibitors that work particularly well in patients with certain mutations in BRCA1/2, and their family members should get tested to see if they are also at heightened risk for cancers.
Myriad's companion diagnostics business got a boost last month, when the US Food and Drug Administration approved AstraZeneca's PARP inhibitor Lynparza (olaparib) for metastatic breast cancer patients who have BRCA mutations. Simultaneously, the agency also expanded the indication for Myriad's BRACAnalysis CDx as a test that can identify which breast cancer patients have germline BRCA mutations and therefore are most likely to benefit from Lynparza. The agency had previously approved BRACAnalysis CDx for identifying advanced ovarian cancer patients who are likely to benefit from fourth-line treatment with Lynparza, a more limited indication for the test.
The company estimated that there are 155,000 metastatic breast cancer survivors in the US, and around 125,000 of these patients don't know their BRCA germline mutation status. There are also 60,000 new patients diagnosed with metastatic breast cancer each year. "Given the FDA approval of BRACAnalysis CDx, we believe there will now be a significant motivation for these patients to be tested to determine if they're eligible for [Lynparza]," Capone said.
Myriad is collaborating with AstraZeneca to commercialize the drug/test combination. "We're also initiating one of our largest ever direct-to-patient and direct-to-provider digital marketing campaign in support of this important launch, which have historically generated significant returns," Capone said, adding that the company's sales team will target and make more frequent calls on the 3,300 oncologists that treat over 75 percent of metastatic breast cancer patients in the US.
Myriad is also working to expand BRACAnalysis CDx and MyChoice HRD, which combines BRCA1/2 testing and an assessment of a tumor's genomic instability status, in a number of new tumor types and indications. For example, Pfizer used Myriad's BRACAnalysis CDx to identify advanced breast cancer patients with BRCA mutations and enroll them in the Embraca trial involving its PARP inhibitor talazoparib. At SABCS in December, the drugmaker announced that advanced breast cancer patients with BRCA1/2 mutations receiving the drug lived, on average, three months longer without their disease progressing, compared to those receiving chemotherapy chosen by their doctors.
"Myriad plans to submit a supplementary premarket approval application to the FDA" for BRACAnalysic CDx for this treatment indication, Capone said.
After hereditary cancer testing, the GeneSight pharmacogenetic test was the next biggest contributor to molecular diagnostics revenues in Q2, bringing in $31.7 million, a 46 percent increase from the prior year. By the end of fiscal year 2018, Myriad is expecting to present and publish the full data from a 1,200-patient randomized-controlled trial evaluating GeneSight's ability to guide psychiatric treatment response in major depressive disorder.
Myriad earlier presented top-line data from this study, which showed that patients tested with GeneSight had statistically significantly improved remission rates and response rates at eight weeks, compared to patients receiving standard care. After eight weeks, GeneSight-tested patients also had a greater improvement in depression symptoms compared to the standard care arm, though the results weren't statistically significant.
Myriad executives have previously explained that the trial parameters presented a very high bar for GeneSight to meet, particularly because the study compared the pharmacogenetic test's ability to guide therapy not against a placebo-treated group, but against physician's choice of therapy for a patient.
"Psychiatrists appreciate how difficult psychotropic drug studies are," Capone said. He added that Myriad has had productive discussions with large payors under non-disclosure agreements and believes that most will issue positive coverage determinations after data from this study are published in a peer-reviewed journal.
Myriad is also conducting a study called IMPACT (Individualized Medicine: Pharmacogenetic Assessment and Clinical Treatment) in collaboration with the Canadian Center for Addiction and Mental Health, which to date has enrolled more than 8,000 patients with a variety of mental disorders. In one portion of this study, researchers compared the performance of GeneSight-guided treatment in 2,000 depressed patients seen by primary care docs and psychiatrists. The top-line results showed that patients seen in the primary care setting had better outcomes than those seen by psychiatrists in terms of remission, treatment response, and symptom improvement.
Myriad plans to publish on this by the end of the fiscal year and share the data with the MolDx program, which evaluates molecular diagnostics for Medicare coverage. "We believe this data will be pivotal in broadening Medicare coverage to include primary care physicians," Capone said.
The company is also trying to broaden payor coverage for Vectra DA, a test that measures 12 proteins to gauge rheumatoid arthritis disease activity. In discussions with commercial payors, Myriad has identified questions that they would like answered about the clinical utility of the test.
For example, some payors want more clarity on how physicians should modify treatment based on test scores. In response, Myriad is in the process of publishing a paper on the topic, and based on the clinical utility data, will add a medical management protocol to the Vectra DA test report. The company is also generating retrospective and prospective data to address payors' questions about whether using Vectra DA to manage patients actually improves their outcomes.
In December, based on feedback from doctors, Myriad launched an enhanced Vectra DA report that provides a test score based on the 12-biomarker algorithm and another score that factors in the patient's age, gender, and body fat (adiposity), to better inform treatment decisions. The report also now includes a measure called "minimally important difference," which doctors can use to determine if the patient's test result indicates a statistically meaningful change in disease activity. If a patient with a moderate or high Vectra DA score has a change of more than 7.5 points, then that's considered statistically meaningful.
During the call, Capone also highlighted the publication of a new study in the Annals of Rheumatic Diseases that demonstrated a strong link between Vectra DA scores and cardiovascular disease. The study evaluated Medicare claims data from more than 70,000 patients and found that for every 10-point change in the test score, the hazard ratio for a major coronary event was 1.32 and was statistically significant.
"Patients with rheumatoid arthritis are at double the risk of heart disease already, and according to this study, a patient with a Vectra DA score of 60 would have a three times greater risk of a major coronary event compared to a patient with a Vectra DA score of 20," Capone said. This publication adds to the clinical utility data for Vectra DA, and future versions of the test report may include information about a patient's risk for cardiovascular disease.
Myriad CFO Bryan Riggsbee said that in Q3, Myriad is assuming BRACAnalysis CDx will contribute only modestly to hereditary cancer revenue. Based on historical experience, the company is expecting hereditary cancer testing revenues to be sequentially down in Q3, and then rise again in Q4. Riggsbee projected GeneSight revenues to be sequentially flat in Q3, but said that this would likely be balanced out by volume growth and improved test pricing in the Medicare clinical lab fee schedule.
Vectra DA revenues are expected to increase in Q3 and Q4, boosted by volume and favorable Medicare pricing under the Protecting Access to Medicare Act. Similarly, EndoPredict revenues are projected to increase in the third and fourth quarter, due to growing US test volumes and increases in average selling price, resulting from a Medicare local coverage determination and the implementation of private payor contracts.
Myriad expects MyPath Melanoma ― a 23-gene expression test that distinguishes between a benign nevus and a malignant melanoma when histopathology cannot definitively make the call ― will contribute to revenue growth in fiscal year 2019. The company is hoping that when NCCN updates its guidelines in coming months, it will support the use of MyPath Melanoma, which in turn would help sway payors. "When we obtain broader reimbursement, we'll expand our sales team and increase our marketing spend to access the entire market of 1,000 dermatopathologists," Capone said.