Clovis' ARIEL3 is a pivotal study of rucaparib that is randomized and double-blind, which compares the effects of rucaparib against a placebo. Patients include individuals diagnosed with ovarian cancer with the purpose of extend the period of time for which the disease is controlled after a complete or partial response to platinum-based chemotherapy.
Study Results
Top-line data from the phase 3 ARIEL3 trial successfully achieved its primary endpoint of improved progression-free survival in each of the three populations studied, Clovis stated. Moreover, PFS was also improved among the rucaparib group compared with placebo by blinded independent central review, a key secondary endpoint.
The company now plans to submit the findings to obtain a supplemental New Drug Application within the next four months for a second-line and later maintenance treatment indication for all women with platinum-sensitive ovarian cancer.
"We are very pleased with these positive ARIEL3 topline results that strongly demonstrate the potential of rucaparib to help women with platinum-sensitive, advanced ovarian cancer," said Patrick J. Mahaffy, president and CEO of Clovis Oncology. "These results reinforce the potentially foundational role of rucaparib in the management of advanced ovarian cancer, as demonstrated by both investigator review and the blinded independent central review. Most importantly, we are grateful to the patients, caregivers and investigators who participated in this study. We look forward to sharing these data in greater detail at a medical meeting later this year and submitting our sNDA as rapidly as possible, with the ultimate goal of making rucaparib available to more women battling ovarian cancer."
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