OlympiAD was the first positive Phase III trial to evaluate the efficacy and safety of a PARP inhibitor beyond ovarian cancer

Lynparza tablets reduced risk of disease worsening or death by 42 per cent

The overall safety profile was consistent with previous trials of Lynparza

AstraZeneca has presented positive results from its Phase III OlympiAD trial that showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for patients treated with Lynparza tablets (300mg twice daily), compared to treatment with physician’s choice of a standard of care chemotherapy.1 In addition to meeting its primary endpoint of PFS assessed by blinded independent central review (BICR), the trial showed that patients treated with Lynparza had a 42 per cent reduction in risk of their disease worsening or death (HR 0.58; 95% CI 0.43,0.80; p=0.0009; median 7.0 vs 4.2 months) compared to those who received chemotherapy (capecitabine, vinorelbine, eribulin).1

The data were presented at the 2017 ASCO Annual Meeting in Chicago, during today’s Plenary Session from 15:10 – 15:25 CDT (Abstract LBA4).1 Additionally, the trial was designated the “Best of ASCO” selection, underscoring the importance of these results for patients and physicians.

“The demonstrated benefit of Lynparza compared with chemotherapy in the OlympiAD study comes as welcome news for women with BRCA-mutated metastatic breast cancer,” said Dr. Karen Gelmon, Medical Oncologist, British Columbia Cancer Agency and Professor of Medicine, University of British Columbia. “There is a high unmet need when it comes to treating BRCA- mutated metastatic breast cancer. These results mean that this well tolerated oral treatment may provide prolonged progression-free survival for some of these women, offering a non- chemotherapy treatment alternative.”

Patients in the trial had HER2-negative germline BRCA1 or BRCA2-mutated breast cancer and were receiving Lynparza as their first, second or third-line medicine for metastatic disease. Before enrolment, patients had prior treatment with an anthracycline (unless contraindicated) and a taxane; hormone receptor-positive patients received at least one endocrine medicine or were not eligible for endocrine medicines.1

Secondary endpoints showed an improvement in time until second progression or death (PFS2) in the Lynparza arm of the trial, compared to those treated with chemotherapy (HR 0.57; 95% CI:

0.40-0.83).1 In addition, the objective response rate (ORR) was more than doubled, with 59.9 per cent of patients in the Lynparza arm showing response to treatment, compared to 28.8 per cent of patients treated with chemotherapy.1

“The OlympiAD study results are very promising as this is the first time a targeted therapy has shown benefit over the current standard of care for patients with HER2-negative gBRCA mutated metastatic breast cancer,” said Dr. Neil Maresky, Vice President, Scientific Affairs with AstraZeneca Canada. “This also marks an important milestone for Lynparza as this is the first positive Phase III study in which a PARP inhibitor has shown clinical value for patients outside of ovarian cancer.”

A review of the Lynparza safety data from the OlympiAD trial was consistent with previous Lynparza trials and did not identify any new safety signals. There was a lower incidence of grade ≥3 adverse events in the Lynparza arm compared to the chemotherapy arm (36.6% vs 50.5% respectively). A smaller proportion of patients discontinued treatment in the Lynparza arm compared to the chemotherapy arm (4.9% vs 7.7% respectively).