Clovis Oncology announces publication of data from the Phase 3 ARIEL3 study of rucaparib for maintenance treatment of advanced ovarian cancer in The Lancet
The ARIEL3 study successfully achieved its primary and key secondary endpoints - improved progression-free survival (PFS) by both investigator review and blinded independent central review (BICR), respectively - in each of the three populations studied, as well as its exploratory endpoints.
- Based on the ARIEL3 findings, Clovis Oncology plans to submit a sNDA to the FDA for a second line or later maintenance treatment indication in ovarian cancer by the end of October 2017.
- In early 2018, the Company plans to file an MAA in Europe for the maintenance treatment indication upon receipt of a potential approval for the treatment indication.