Clovis' rucaparib successful in late-stage ovarian cancer study; shares ahead 5% premarket
Sep. 8, 2017 8:02 AM ET|About: Clovis Oncology (CLVS)|By: Douglas W. House, SA News Editor
Clovis Oncology (NASDAQ:CLVS) is up 5% premarket on light volume in response to its announcement of positive results from the Phase 3 ARIEL3 study evaluating rucaparib in women with platinum-sensitive advanced ovarian cancer.
The trial achieved it primary endpoint of demonstrating a statistically valid improvement in progression-free survival (PFS) by both investigator review and blinded independent central review in each of the three populations studied.
Median PFS by investigator review in BRCA-positive patients was 16.6 months versus 5.4 months for placebo. In homologous recombination deficiency (HRD) patients, the difference was 13.6 months vs. 5.4 months and in the intent-to-treat group, 10.8 months vs. 5.4 months. All were highly statistically significant.
Median PFS superiority by blinded independent central review was more pronounced: 26.8 mo. vs . 5.4 mo., 22.9 mo. vs. 5.5 mo. and 13.7 mo. vs. 5.4 mo., respectively.
The results are being presented today at ESMO in Madrid.
The results will support a supplemental New Drug Application in the U.S. for second-line or later maintenance treatment of ovarian cancer, to be filed by the end of October. The company plans to file a marketing application Europe after the European Commission approves the initial use (marketing application filed in Q4 2016).
The FDA OK'd rucaparib, branded as Rubraca, in December 2016 for the treatment of patients with BRCA-positive ovarian cancer who have received at least two prior lines of chemo.
Previously: Clovis' Rubraca improved PFS in patients with advanced platinum-sensitive ovarian cancer in late-stage study; U.S. marketing application within four months; shares ahead 41% premarket (June 19)
Previously: FDA OKs Clovis' rucaparib for ovarian cancer; shares up 15% (Dec. 19, 2016)