Myriad Genetics has released the results of its Phase III POLO study, which showed that BRACAnalysis CDx companion diagnostic test identifies patients with metastatic pancreatic cancer who were treated with Lynparza (olaparib).
Image: AstraZeneca new R&D centre and global headquarters lab in Cambridge. Photo: Courtesy of AstraZeneca.
POLO is a Phase III randomised, double-blinded, placebo-controlled, multicentre trial involving 154 patients with gBRCAm metastatic pancreatic cancer whose disease had not progressed on 1st-line platinum-based chemotherapy.
The US-based molecular diagnostic company has presented the results of the study at the 2019 American Society of Clinical Onocology (ASCO) meeting held in Chicago.
The primary endpoint of the study was progression-free survival (PFS) and key secondary endpoints included overall survival, time to second disease progression, overall response rate, disease control rate and health-related quality of life.
The company said that the POLO study precisely demonstrated that the patients with a germline mutation, and whose disease had not advance on first-line platinum-based chemotherapy, when treated with Lynparza, have shown a significant improvement in PFS, compared with placebo.
The treatment using Lynparza has improved the time without disease progression by a median of 7.4 months, while those on placebo showed 3.8 months.
Lynparza is a novel PARP inhibitor commercialized by AstraZeneca and Merck, and is not currently approved by the US Food and Drug Administration (FDA) for gBRCAm pancreatic cancer.
AstraZeneca Oncology R&D senior vice president and Precision Medicine head Ruth March said: “Our long-standing collaboration with Myriad Genetics Inc. 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.”
Myriad Genetics chief medical officer Johnathan Lancaster said: “The POLO study demonstrated the clinical effectiveness of the BRACAnalysis CDx test to identify germline BRCA mutations and enable transformative precision therapy for patients with pancreatic cancer.
“The message for clinicians is clear: all patients with pancreatic cancer should receive a BRACAnalysis CDx test to determine their BRCA status.”
The National Comprehensive Cancer Network (NCCN) has updated its guidelines to recommend universal germline BRCA testing for all patients with pancreatic cancer.
Pancreatic cancer is said to be the third most common cause of cancer-related death in the US, and germline BRCA-mutated pancreatic cancer is estimated to account for approximately seven percent of all cases.
Myriad has announced its plans to apply for a supplementary Premarket Approval (sPMA) from FDA to authorize its BRACAnalysis CDx as a companion diagnostic for Lynparza in patients with pancreatic cancer.
In addition, Myriad has signed an exclusive commercialization agreement with AstraZeneca.
Myriad Oncology president Nicole Lambert said: “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.
“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.”