Results of phase III SOLO3 trial of Lynparza for patients with germline BRCA1/2-mutated (gBRCAm) advanced ovarian cancer.
AstraZeneca and MSD Inc., presented full results from the Phase III SOLO3 trial which compared Lynparza (olaparib) with physician’s choice of chemotherapy in the treatment of patients with germline BRCA1/2-mutated (gBRCAm) advanced ovarian cancer who had received two or more prior lines of chemotherapy.
The results from the trial, presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, showed a statistically-significant and clinically-meaningful improvement in objective response rate (ORR) for Lynparza vs. chemotherapy (72.2% vs. 51.4% [95% CI, 1.40-4.58], p=0.002). ORR measures the proportion of patients with reduction in tumour burden of a predefined percentage.
The trial also met the key secondary endpoint of progression-free survival (PFS), demonstrating a statistically-significant and clinically-meaningful improvement in the time patients lived without disease progression for Lynparza (13.4 months) vs. chemotherapy (9.2 months [HR 0.62] p=0.013.
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