Clovis Oncology Inc. (CLVS) saw its shares make a massive gain early on Monday after the company announced top-line data from its confirmatory Phase 3 Ariel3 trial of rucaparib for the treatment of ovarian cancer. Overall, rucaparib showed statistical significance in all 564 patients enrolled in the study.
Ultimately, the firm said that it achieved the primary endpoint of improved progression-free survival (PFS) by investigator review. PFS was also improved in the rucaparib group compared with placebo by blinded independent central review, a key secondary endpoint.
Based on these findings, the company plans to submit a supplemental New Drug Application (NDA) within the next four months for a second-line and later maintenance treatment indication.
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Ovarian cancer is considered the deadliest gynecologic cancer and, until recently, there have been limited treatment options for this advanced disease. It seems that Clovis has made some serious headway.
Patrick J. Mahaffy, president and CEO of Clovis, commented:
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. 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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Shares of Clovis closed Friday at $59.97, with a consensus analyst price target of $71.17 and a 52-week range of $11.57 to $74.94. The stock was last trading up 44% at $86.20 in early trading indications Monday.