BioCentury
ARTICLE | Clinical News

Lynparza: Additional Ph III SOLO-2 data

March 17, 2017 1:04 PM UTC

Additional data from the double-blind, international Phase III SOLO-2 trial in 295 patients with platinum-sensitive, relapsed or recurrent BRCA-mutant ovarian cancer showed that maintenance treatment with twice-daily 300 mg oral Lynparza led to a an investigator-assessed median PFS, the primary endpoint, of 19.1 vs. 5.5 months for placebo (HR=0.3, 95% CI: 0.22, 0.41, p<0.0001). By blinded independent central review, Lynparza led to a median PFS of 30.2 vs. 5.5 months for placebo (HR=0.25, 95% CI: 0.18, 0.35, p<0.0001). Lynparza also significantly improved median time to second progression or death vs. placebo (not reached vs. 18.4 months, HR=0.5, 95% CI: 0.34, 0.72, p=0.0002). Data were presented at the Society of Gynecologic Oncology meeting in National Harbor. Last October, AstraZeneca reported top-line data from SOLO-2 showing that Lynparza met the primary endpoint of improving median PFS vs. placebo (see BioCentury, Oct. 31, 2016)...

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