Clovis OKd to file for new ovarian cancer indication for med in Europe

• The filing is based on positive phase 3 ARIEL3 clinical trial data in which rucaparib significantly improved progression free survival (PFS) compared to placebo in all primary efficacy ovarian cancer patient populations
• Timing of validation by EMA may allow for a CHMP opinion on maintenance treatment by year-end 2018

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the European Medicines Agency (EMA) has validated the application for a Type II variation to the marketing authorization for Rubraca^® (rucaparib) to include maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum based chemotherapy. This validation confirms the submission is complete and begins the EMA’s centralized review process.

“We are very pleased to receive validation of the variation to the Rubraca marketing authorization by the EMA, which brings us a step forward in making rucaparib available to more women with recurrent ovarian cancer in Europe,” said Patrick J. Mahaffy, CEO and President of Clovis Oncology.

This submission is based on the positive results from the phase 3 ARIEL3 study, which evaluated rucaparib in the ovarian cancer maintenance treatment setting among three populations: 1) BRCA mutant (BRCAmut+) 2) HRD positive inclusive of BRCAmut+ and, 3) all patients treated in ARIEL3. ARIEL3 successfully achieved its primary endpoints, extending investigator assessed progression-free survival (PFS) versus placebo in all patients treated, regardless of BRCA status. Safety findings from the ARIEL3 trial were consistent with previous clinical trials.

In May 2018 rucaparib was granted Marketing Authorization in Europe for adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.¹

Based on the timing of this submission, the company anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) by end of 2018.

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