Agreements

Date: 2018-01-03

Type of information: Collaboration agreement

Compound: companion diagnostics for the olaparib Phase 3 clinical development program,, myChoice® HRD Plus

Company: Myriad Genetics (USA - UT) AstraZeneca (UK)

Therapeutic area: Cancer - Oncology

Type agreement: collaboration - development

Action mechanism: companion diagnostic Myriad's myChoice HRD Plus is the most comprehensive homologous recombination deficiency test to detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice HRD Plus test is a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions) and up to 90 other genes and molecular markers including microsatellite instability associated with DNA repair pathways. Positive myChoice HRD Plus scores, reflective of DNA repair deficiencies, are prevalent in all breast cancer subtypes, ovarian cancer and most other major cancers. It is estimated that 1.4 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. Learn more: http://myriadmychoice.com/ About Lynparza Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumor DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells. Lynparza is the foundation of AstraZeneca's industry-leading portfolio of compounds targeting DNA damage response (DDR) mechanisms in cancer cells. Lynparza is currently approved in the United States for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy and for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Patients are selected for therapy based on Myriad's FDA-approved companion diagnostic. It is also approved by regulatory health authorities in the EU for use as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in res  

Disease: various tumor types including BRCA-mutated breast and ovarian cancers

Details:

• • On September 4, 2013, Myriad Genetics has announced that it has entered into an expanded, nonexclusive global collaboration agreement with AstraZeneca to provide companion diagnostics for the olaparib Phase 3 clinical development program. Olaparib is being developed by AstraZeneca for the treatment of various tumor types including BRCA-mutated breast and ovarian cancers. Simultaneously AstraZeneca has announced enrollment of the first patient in the Phase III clinical programme for the treatment of BRCA mutated ovarian cancer. Under the expanded agreement, Myriad will build out a new laboratory within its Salt Lake City facility in accordance with FDA regulations for companion diagnostic devices. In August, the FDA approved the Investigational Device Exemption (IDE) for BRACAnalysis® filed by Myriad, enabling clinical studies with olaparib to include BRACAnalysis testing as a companion diagnostic.
• The collaboration with AstraZeneca to develop a novel companion diagnostic test to identify candidates for treatment with olaparib began in 2007.

Financial terms:

Latest news:

• • On January 3, 2018, Myriad Genetics announced that AstraZeneca will use  myChoice® HRD Plus in an exploratory analysis to identify women with advanced ovarian cancer who may benefit from maintenance treatment with Lynparza® (olaparib) and Avastin® (bevacizumab). Financial terms were not disclosed.
• Under the agreement, Myriad will use its myChoice HRD Plus test to evaluate patients enrolled in an ongoing Phase III trial. In this collaboration, the companies will use the myChoice HRD Plus test to identify cases with homologous recombination deficiencies (HRD).
•  In December 2014, Myriad received FDA approval for BRACAnalysis CDx to help identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib. BRACAnalysis CDx is Myriad's first FDA-approved companion diagnostic and was the first-ever laboratory developed test approved by the FDA.

Is general: Yes