AstraZeneca 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 (olaparib) tablets (300mg twice daily), compared to treatment with physician’s choice of a standard of care chemotherapy. 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% reduction in risk of their disease worsening or death compared to those who received chemotherapy (capecitabine, vinorelbine, eribulin).
Mark E. Robson, Clinic Director of the Clinical Genetics Service at Memorial Sloan Kettering Cancer Center, New York and Principal Investigator of OlympiAD said, “The OlympiAD data presented today demonstrate the benefit of olaparib in delaying the progression of advanced BRCA-mutated breast cancer. With few alternatives available, a targeted non-chemotherapy oral treatment in this setting could be a beneficial new option for patients.”
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said, “The OlympiAD results shared today mark the first time a targeted therapy shows benefit over the current standard of care for patients with HER2-negative gBRCA-mutated metastatic breast cancer. This also represents an important milestone for Lynparza as this is the first positive Phase III trial in which a PARP inhibitor has shown a significant benefit for patients outside of ovarian cancer.”
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.
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). In addition, the objective response rate (ORR) was more than doubled, with 59.9% of patients in the Lynparza arm showing response to treatment, compared to 28.8% of patients treated with chemotherapy.
A review of the Lynparza safety data from the OlympiAD trial did not identify any new safety signals and the overall safety profile was consistent with previous trials of Lynparza. 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).