AstraZeneca and Merck reveal positive results from Phase III SOLO-1 Lynparza trial.
M2 EQUITYBITES-June 29, 2018-AstraZeneca and Merck reveal positive results from Phase III SOLO-1 Lynparza trial
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United Kingdom-based AstraZeneca and United States-based Merck have revealed positive results from the randomised, double-blinded, placebo-controlled, Phase III SOLO-1 trial of Lynparza (olaparib) tablets, it was reported yesterday.
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 the product was consistent with earlier trials. Based upon these data, both firms plan to start discussions with health authorities regarding regulatory submissions.
SOLO-1 is a Phase III randomised, double-blinded, placebo-controlled, multicentre trial to assess the efficacy and safety of Lynparza tablets as first-line maintenance monotherapy compared with placebo, in patients with BRCAm advanced ovarian cancer. The trial randomised 391 patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation who were in clinical complete or partial response following platinum-based chemotherapy. Eligible patients were randomised (2:1) to receive Lynparza 300mg tablets twice daily or placebo tablets twice daily. The primary endpoint was progression-free survival and key secondary endpoints included time to second disease progression or death and overall survival.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jun 29, 2018|
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