AstraZeneca and Merck will present full results at a future meeting; Myriad Genetics will file a supplemental application for its companion diagnostic.
AstraZeneca and MSD this week revealed topline results from the late-stage POLO trial, which showed meaningful improvement in progression-free survival (PFS) for patients who took olaparib (Lynparza) compared with placebo.
POLO is a randomized, double-blind, placebo-controlled trial studying the efficacy of olaparib as a first-line maintenance monotherapy for patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed to platinum-based chemotherapy. AstraZeneca and MSD, who are developing olaparib together, will present full results at an upcoming scientific meeting. MSD is known as Merck in the United States.
A first-in-class PARP inhibitor, olaparib is approved to treat multiple indications of advanced ovarian, fallopian, and metastatic breast cancer, including those with both inherited and acquired BRCA mutations. The BRCA1 and BRCA2 genes help cells repair DNA damage, and inherited mutations can make both women and men more likely to develop certain cancers.
Olaparib works by blocking DNA damage response in cells and tumors that have this deficiency in homologous recombination repair. The drug is used maintenance treatment in some settings and after cancer returns in others.
“This is the first positive phase III trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic cancer, a devastating disease with critical unmet need,” Jose Baselga, MD, PhD, executive vice president for Research and Development at AstraZeneca, said in a statement. “The results of POLO provide further evidence of the clinical benefit of Lynparza across a variety of BRCA-mutated tumor types. We will discuss these results with global health authorities as soon as possible.”
At the time that the companies announced the results, Myriad Genetics announced it would file a supplementary premarket approval application with FDA for its BRCAnalysis CDx to be used as a companion diagnostic for olaparib in the indication of metastatic pancreatic cancer.
“The results of the POLO trial strong support use of the BRCAnalysis CDx test to help inform treatment decisions in the metastatic pancreatic cancer setting and will expand the patient population who can benefit from BRCA testing,” Myriad’s Chief Medical Office Johnathan Lancaster MD, PhD, said in a statement.
According to the statement, BRACAnalysis CDx is the only FDA-approved germline BRCA1/2 test.