OlympiAD Trial Reports Success With Olaparib and Predictive Diagnostic Test

A phase 3 trial evaluating olaparib (Lynparza) against standard of care chemotherapy in women with HER2-negative metastatic breast cancer has seen significant improvement in progression-free survival (PFS) with olaparib. Additionally, the trial has also reported that a BRCA diagnostic test could successfully identify positive responders to olaparib.

The trial, OlympiAD, is a randomized, multi-center study designed to study whether olaparib is safer and more effective than physicians’ choice of chemotherapy: capecitabine, vinorelbine, or eribulin. The trial, which has global sites, was conducted in 302 patients with HER2-negative metastatic breast cancer, with germline BRCA1/2 mutations. PFS was the primary trial end point; secondary endpoints included overall survival, time to second progression or death, objective response rate, and effect on health-related quality of life.

In a press release announcing the results, executive vice president of the Global Medicines Development at AstraZeneca, which is developing the drug, said “These results are positive news for patients with BRCA-mutated metastatic breast cancer, a disease with a high unmet need, and are the first positive phase 3 data for a PARP inhibitor beyond ovarian cancer.”

The OlympiAD study also successfully tested BRACAnalysis CDx, an FDA-approved genetic test that detects BRCA mutations in patients with HER2-negative breast cancer. In this trial, BRACAnalysis CDx identified patients who responded to olaparib. Of the 302 patients in the study, 297 (98%) tested positive for germline BRCA1/2 mutations.

Johnathan Lancaster, MD, PhD, chief medical officer of Myriad Genetic Laboratories, which has developed the diagnostic test, said that BRACAnalysis CDx can inform clinical treatment decisions in metastatic breast cancer and “expand the patient population who can benefit from BRCA testing.”

BRACAnalysis CDx is the first laboratory-developed companion diagnostic (CD) test to be FDA- approved. It was approved as a CD for olaparib to be used in the fourth-line setting for patients with ovarian cancer in 2014.

AstraZeneca is working toward submitting olaparib for an FDA review.