Monday June 19, 2017 0 comments
BOULDER -- Clovis Oncology (NASDAQ: CLVS) today announced topline data from the confirmatory phase 3 ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression-free (PFS) by investigator review in each of the three populations studied.
Clovis said PFS was also improved in the rucaparib group compared with placebo by blinded independent central review (BICR), a key secondary endpoint.
Based on these findings, the company said it plans to submit a supplemental New Drug Application (sNDA) within the next four months for a second-line and later maintenance treatment indication for all women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy.
“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, Clovis president and CEO.
“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.”
“Based on these encouraging data, it is clear that rucaparib demonstrates a clinically meaningful impact in delaying disease recurrence in women in this trial with advanced ovarian cancer,” said Robert L. Coleman, M.D., professor and vice chair, clinical research, in the Department of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center in Houston and the U.S. Principal Investigator for the ARIEL3 study.
“The PFS and safety results achieved in this study are particularly promising, because they suggest women are able to stay on rucaparib for a prolonged period of time while gaining benefit.
“It is also clinically significant that rucaparib not only sustained the most recent response to platinum, but in some patients also enhanced that response, including the elimination of residual tumor.”
“I first dosed a patient with rucaparib over five years ago, and these robust and exciting data are consistent with my experience,” said Jonathan Ledermann, professor of medical oncology, director, Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, and European and ROW Principal Investigator for the ARIEL3 study.
“These results show that rucaparib has the potential to provide an enduring and important clinical benefit in women with advanced ovarian cancer, irrespective of their tumor genetics.
“This is a very important step forward for women with advanced ovarian cancer.”
“Ovarian cancer is the deadliest gynecologic cancer and until very recently, there were limited treatment options for advanced disease,” said David Barley, CEO of the National Ovarian Cancer Coalition.
“The potential for targeted therapies that can meaningfully delay recurrence for a large percentage of women with this disease is significant, and we are encouraged by these results from ARIEL3.”