publication date: Jun. 29, 2018
Clinical Roundup Lynparza delays disease progression in phase III trial in first-line ovarian cancer
AstraZeneca and Merck announced positive results from the randomized, double-blind, placebo-controlled, phase III SOLO-1 trial of Lynparza (olaparib) tablets.
Women with BRCA-mutated advanced ovarian cancer treated first-line with Lynparza maintenance therapy had a statistically significant and clinically meaningful improvement in progression-free survival compared to placebo.
The safety and tolerability profile of Lynparza was consistent with previous trials. Based upon these data, AstraZeneca and Merck plan to initiate discussions with health authorities regarding regulatory submissions.
Lynparza is not FDA-approved for front-line ovarian maintenance treatment. Lynparza is indicated for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCA mutation status, and for the treatment of advanced ovarian cancer patients with a gBRCA-mutation previously treated with three or more lines of chemotherapy.
Physicians should select advanced ovarian cancer patients for therapy based on a FDA-approved companion diagnostic. Additionally, the ongoing GINECO/ENGOTov25 phase III trial, PAOLA-1, is testing the effect of Lynparza in combination with bevacizumab as a first-line maintenance treatment in women with newly diagnosed advanced ovarian cancer, regardless of their BRCA status. Results are expected in 2019.
In a related development, Myriad Genetics Inc. announced that its BRACAnalysis CDx test had … Continue reading Lynparza delays disease progression in phase III trial in first-line ovarian cancer
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