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MDx/CDx Focus: BioMarin to Use Myriad HRD Test; Roche's Kadcyla Approval in EU


Myriad, BioMarin Ink Deal to Use HRD Test to ID Responders to PARP Inhibitor

Myriad Genetics and BioMarin have inked a deal in which the drug developer will use Myriad's Homologous Recombination Deficiency Test to gain a more complete picture of the kinds of tumors that are sensitive to its investigational PARP inhibitor BMN-673.

"The biology of cancer is complicated, and while the analysis of multiple gene targets may identify a subset of patients who will respond to PARP inhibitors, we need a more comprehensive test capable of identifying all patients who may benefit from treatment with PARP inhibitors or DNA damaging agents," Jerry Lanchbury, Myriad's chief scientific officer, said in a statement announcing the partnership.

BioMarin is already developing BMN-673 for breast cancer patients with germline BRCA1/2 mutations who have an impaired ability to repair DNA damage. The drug developer is using Myriad's BRACAnalysis test to identify best responders in the pivotal Phase III metastatic breast cancer study.

However, clinical data suggests that patients with mutations in other genes involved in DNA repair may derive benefit from PARP inhibition. As such, BioMarin is using Myriad's NGS-based HRD test to try to identify those responders.

"Myriad's HRD assay has the potential to complement the development of our PARP inhibitor BMN 673 to identify cancer patients who are most likely to benefit from the therapy," BioMarin's Chief Scientific Officer Len Post said in a statement.

"While it is impossible to predict all of the genetic causes of DNA repair deficiency, our HRD test solves this problem by measuring the ultimate effect, which presents as a DNA scar," Lanchbury said in a statement. When DNA is damaged and then repaired by homologous recombination, it leaves a scar. This scar replicated in cancer cells may compromise their ability to repair DNA, making them more susceptible PARP inhibitors.

Myriad's next-generation sequencing-based HRD test that gauges BRCA1/2 gene mutations in tumor tissue, as well as a number of other markers involved in DNA repair. The firm is planning to launch its HRD test for platinum therapies in 2015 and for PARP inhibitors in 2017. PharmaMar is also using Myriad's HRD test in clinical trials for an investigational DNA damaging drug PM1183.

Meanwhile, AstraZeneca has used Foundation Medicine's FoundationOne NGS test to look at how cancer patients respond to its PARP inhibitor olaparib. As reported by PGx Reporter in a recent article, Clovis is working with Foundation to develop a NGS-based companion test for its PARP inhibitor rucaparib.

Separately, Myriad has also launched the "Just Ask" patient campaign to encourage families to discuss their history of cancer during the holiday season and take the firm's hereditary cancer quiz. "Most cancers occur by chance, but cancer is hereditary in some families," Myriad states on its website. "You can’t change your genes, but, by knowing your family’s history, you and your family members can take actions to reduce the disease risk that may exist."

Roche/ImmunoGen's HER2 Breast Cancer Drug Kadcyla Approved in EU

The European Commission has okayed Roche's Kadcyla (trastuzumab emtansine) for marketing in the EU as a treatment for HER2-positive unresectable or advanced breast cancer patients who have been previously treated with Herceptin (trastuzumab) and a taxane.

Kadcyla joins Roche's Herceptin with ImmunoGen's anti-cancer agent DM1 via a linker. With the approval of Kadcyla in the EU, Roche will pay ImmunoGen $5 million in milestone payments.

The deal between Roche and ImmunoGen give Roche global development and commercialization rights for Kadcyla. Meanwhile, ImmunoGen can receive royalties on product sales and milestone payments.

The drug is already commercially available in the US, Japan, and other geographies. EU regulatory authorities reviewed data from the Phase III EMILIA trial to grant their approval for Kadcyla.

"In the EU and other international markets, the timing of the commercial availability of Kadcyla after approval can vary due to national differences in processes for establishing pricing/reimbursement, with some countries – including Germany – able to launch shortly after approval," ImmunoGen said in a statement.

Roche is also investigating Kadcyla for the first-line treatment of HER2-positive metastatic breast cancer, for early stage HER2-positive breast cancer, and for advanced HER2-positive gastric cancer.