Myriad Genetics, Salt Lake City, has announced that its BRACAnalysis CDx companion diagnostic effectively identified patients with metastatic pancreatic cancer who benefitted from treatment with Lynparza (olaparib) in the Phase III Polo study.1
“Our long-standing collaboration with Myriad Genetics has enabled us to deliver the positive Polo study in pancreatic cancer patients, demonstrating our shared ambition to target precision medicines to the right patients across different cancers,” says Ruth March, PhD, senior vice president and head of precision medicine for oncology research and development at AstraZeneca.
The Polo study demonstrated that patients with a germline mutation whose disease had not progressed on first-line platinum-based chemotherapy had a clinically meaningful and statistically significant improvement in progression-free survival of 7.4 months when treated with Lynparza, compared with 3.8 months for placebo (HR 0.53; p=0.004).
Lynparza is a novel poly ADP ribose polymerase (PARP) inhibitor being commercialized by AstraZeneca and Merck and is not currently approved by FDA for germline BRCA-mutated pancreatic cancer.
“The Polo study demonstrated the clinical effectiveness of the BRACAnalysis CDx test to identify germline BRCAmutations and enable transformative precision therapy for patients with pancreatic cancer,” says Johnathan Lancaster, MD, PhD, chief medical officer at Myriad Genetics. “The message for clinicians is clear: all patients with pancreatic cancer should receive a BRACAnalysis CDx test to determine their BRCA status.”
In February, the National Comprehensive Cancer Network (NCCN) updated its guidelines to recommend universal germline BRCA testing for all patients with pancreatic cancer. Pancreatic cancer is the third most common cause of cancer-related death in the United States, and it is estimated that germline BRCA-mutated pancreatic cancer accounts for approximately 7% of all cases.
“Based on the new NCCN guidelines, clinicians should order a BRACAnalysis CDx test for their patients with pancreatic cancer at the time of diagnosis,” says Lancaster. “The sooner we can identify patients with germline BRCA mutations, the better chance they will have to benefit from precision therapies.”
Myriad intends to file a supplementary premarket approval application with FDA to authorize BRACAnalysis CDx as a companion diagnostic for Lynparza in patients with pancreatic cancer. The company has also signed an exclusive commercialization agreement with AstraZeneca. The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.
“We congratulate AstraZeneca and Merck on the Polo study results and look forward to collaborating with them to improve outcomes for patients with pancreatic cancer,” says Nicole Lambert, president of Myriad Oncology. “BRACAnalysis CDx is the only test approved by FDA to identify germline BRCA mutations, and the Polo study highlights our ongoing commitment to improve outcomes for people with difficult-to-treat cancers.”
For more information visit Myriad Genetics.
- Kindler HL, Hammel P, Reni M, et al. Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III Polo trial [abstract, online]. Plenary session presented at the annual meeting of the American Society of Clinical Oncology, Chicago, May 31–June 4, 2019. J Clin Oncol. 2019;37(suppl):abstract LBA4. Available at: https://meetinglibrary.asco.org/record/174488/abstract. Accessed September 20, 2019.
Pancreatic cancer. Illustration © Sebastian Kaulitzki courtesy Dreamstime (ID 115598118).