Lynparza (olaparib) demonstrated improved progression-free survival (PFS) compared to the placebo arm for patients with ovarian cancer, according to findings from the phase 3 SOLO-2 trial. The single-agent PARP inhibitor was tested in the maintenance setting for patients with advanced BRCA-positive ovarian cancer.
Although specific data from the trial are not yet available, AstraZeneca, the manufacturer of Lynparza, reported that the median PFS with Lynparza was significantly higher than in the Lynparza arm of the phase 2 Study 19 in a similar population. The safety profile for the PARP inhibitor was consistent with results reported from previous trials.
“We are pleased with the robust improvement in progression-free survival demonstrated by Lynparza in the SOLO-2 trial. We will work with regulatory authorities to make Lynparza tablets available as quickly as possible to patients with ovarian cancer. We remain committed to investigating the full potential of Lynparza, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine,” Sean Bohen, M.D., Ph.D., executive vice president, Global Medicines Development, and Chief Medical Officer at AstraZeneca, said in a statement.
The multicenter phase 3 SOLO-2 trial included 295 patients with platinum-sensitive, relapsed/recurrent, BRCA-positive ovarian cancer who had received two or more prior lines of platinum-based chemotherapy. Patients were randomized to receive either Lynparza at 300 mg twice daily or placebo until disease progression.
The latest data from the phase 2 Study 19, which were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, showed that in patients with platinum-sensitive relapsed serous ovarian cancer, Lynparza increased overall survival (OS) when given as maintenance therapy.
Results of the study’s extension showed that the PARP inhibitor demonstrated the greatest OS advantage in women who had a BRCA mutation, according to lead author Jonathan Ledermann, M.D., professor of Medical Oncology at the University College London Cancer Institute and director of the Cancer Research UK & UCL Cancer Trials Centre, who presented the results at ASCO.
Additional key findings were that both time to first subsequent therapy or death (TFST) and time to second subsequent therapy or death (TSST) were substantially prolonged in patients taking Lynparza; again, the greatest benefit was seen in those with a BRCA mutation. Additionally, the unprecedented long-term exposure meant that 13 percent of all trial patients (15 percent of BRCA-mutated patients) received maintenance Lynparza for at least five years. In three years of follow-up since the 2012 analysis, there were no new safety findings.
Study 19 assessed patients with platinum-sensitive, recurrent high-grade serous ovarian cancer (265 patients). They had received two or more prior regimens of platinum-based chemotherapy and experienced complete response or partial response to their most recent regimen. In a double-blind, one-to-one randomization, half the patients received Lynparza 400 mg capsules twice daily as maintenance therapy (136 patients) and half received placebo capsules twice daily (129 patients).
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