SALT LAKE CITY—Recently, Myriad Genetics Inc., which is focused on molecular diagnostics and personalized medicine, announced progress with the BRACAnalysis CDx on two fronts: study results supporting its use as a companion diagnostic with Lynparza for ovarian cancer, and approval for its use with Talzenna for HER2-negative metastatic breast cancer.
The more recent news, coming late in October, revealed that in the Phase 3 SOLO-1 trial, the test accurately identified patients with newly diagnosed, advanced-stage, BRCA-mutated (BRCAm) ovarian cancer who may benefit from treatment with Lynparza (olaparib), which is being developed by AstraZeneca and Merck & Co. (known as MSD outside the United States and Canada). As a result, Myriad planned to submit a supplementary premarket approval (sPMA) application with U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as a companion diagnostic with Lynparza in this patient population.
The companion diagnostic was used in the SOLO-1 trial as part of the testing of Lynparza tablets as a maintenance treatment for patients with newly diagnosed, advanced-stage BRCAm ovarian cancer who experienced a complete or partial response following first-line standard platinum-based chemotherapy. The study results, which were published in the New England Journal of Medicine, indicated that Lynparza maintenance therapy cut risk of disease progression or death by 70 percent.
“SOLO-1 demonstrated the ability of the BRACAnalysis CDx test to accurately identify patients with newly diagnosed, advanced-stage BRCA-mutated ovarian cancer who benefit from Lynparza,” said Dr. Johnathan Lancaster, the chief medical officer of Myriad Genetics. “Importantly, the study findings strongly reinforce the critical importance of BRACAnalysis CDx testing at the time of diagnosis for all patients with ovarian cancer.”
Lynparza is an oral PARP inhibitor being developed by AstraZeneca and Merck & Co. Collaboration between Myriad and AstraZeneca regarding olaparib goes back to 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx, as follows:
- Dec. 2014: FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib.
- August 2017: FDA approved BRACAnalysis CDx as a complementary diagnostic to identify patients with ovarian cancer who are eligible for second-line treatment with olaparib.
- January 2018: FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with metastatic breast cancer who are eligible for second-line treatment with olaparib.
- March 2018: The Japanese Ministry of Health, Labour, and Welfare approved BRACAnalysis CDx as a companion diagnostic to identify patients with metastatic breast cancer who are eligible for second-line treatment with olaparib.
“We congratulate AstraZeneca and Merck on the successful completion and publication [of the] SOLO1 trial. These outstanding findings represent another meaningful advancement for patients with ovarian cancer,” said Lloyd Sanders, president of Myriad Oncology. “BRACAnalysis CDx is a clear-cut example of our commitment to provide high-quality genetic testing and molecular diagnostics that enable personalized medicine and improve health outcomes for patients.”
Less than a week before that news, Myriad announced that the FDA had approved BRACAnalysis CDx to be used by healthcare professionals to identify patients with HER2-negative metastatic breast cancer (mBC) who have a germline BRCA mutation and are eligible for treatment with Pfizer Inc.’s PARP (poly ADP ribose polymerase) inhibitor, Talzenna (talazoparib).
Talzenna is indicated for the treatment of adult patients with deleterious or suspected deleterious germline (inherited) BRCA-mutated HER2-negative locally advanced or mBC. In early October, before the approval had even come through, Myriad had also announced the signing of a commercialization plan with Pfizer as part of an expansion of an existing companion diagnostic agreement related to Pfizer’s investigational PARP.
“We believe this commercial collaboration is another strong indication of Myriad’s global leadership in the field of companion diagnostics for PARP inhibitors and personalized medicine,” said Sanders at that time. “We are excited to be working with Pfizer and towards ensuring patients have access to this class of drugs.”
After the FDA approval was announced, he added: “We congratulate Pfizer on obtaining FDA approval of Talzenna for certain patients living with metastatic breast cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test. We estimate there are more than 60,000 patients diagnosed with or who progress to metastatic breast cancer in the United States every year who qualify for a BRACAnalysis CDx test.”
The FDA approval was based on results from the EMBRACA trial that evaluated Talzenna vs. physician’s choice chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced or mBC.
“Myriad’s BRACAnalysis CDx test was shown in the EMBRACA trial to accurately identify certain patients with a germline BRCA-mutation who may benefit from Talzenna,” said Lancaster. “It is important for patients to know their BRACAnalysis CDx results so they can fully understand their treatment options.”