Wednesday August 8, 2018 0 comments
BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the randomization of the first patient in the Phase 3 ATHENA trial evaluating the combination of Clovis’ Rubraca® (rucaparib), a poly (ADP ribose) polymerase inhibitor (PARP), and Bristol-Myers Squibb’s PD-1 inhibitor, OPDIVO® (nivolumab), for the treatment of advanced ovarian cancer.
ATHENA, sponsored by Clovis, is part of a clinical collaboration with Bristol-Myers Squibb and is being conducted in association with the Gynecologic Oncology Group (GOG) and the European Network for Gynecological Oncological Trials (ENGOT).
GOG and ENGOT are the two largest cooperative groups in the U.S. and Europe dedicated to the treatment of gynecological cancers.
“I am pleased the GOG and ENGOT are conducting the first trial designed to investigate whether the combination of a PARP inhibitor and PD-1 blocking antibody can demonstrate not only an improvement in progression-free survival in the first-line maintenance setting for women with advanced ovarian cancer, but also whether the combination can change the natural course of the disease by delaying or reducing recurrence following front-line therapy,” said Brad Monk, professor of gynecologic oncology at the University of Arizona and Creighton University, medical director of the US Oncology Research Gynecology program in Phoenix and lead investigator of the ATHENA trial.
“Rubraca combination trials such as ATHENA are encouraging to see, because the possible implications are particularly meaningful for women with advanced ovarian cancer, who need a wide range of treatment options,” said Dr. Rebecca Kristeleit, clinical senior lecturer and consultant medical oncologist, University College London, U.K. and ATHENA ENGOT/non-U.S. lead investigator.
“The participation by the GOG and the ENGOT in the evaluation of a PARP inhibitor in combination with a PD-1 agent reflects the interest around this approach.”
ATHENA is a Phase 3, randomized, multinational, double-blind, placebo-controlled, four-arm trial evaluating Rubraca and Opdivo as maintenance treatment following response to front-line treatment in newly-diagnosed ovarian cancer patients.
“The initiation of the Phase 3 ATHENA trial is an important milestone for Clovis and a critical step towards helping women with advanced ovarian cancer, who are in need of new treatment options,” said Patrick J. Mahaffy, Clovis president and CEO.
“We are particularly excited about the potential clinical utility of Rubraca in combination with Opdivo in this setting. The importance of this trial is also underscored by the participation of ENGOT and GOG, which we anticipate may facilitate enrollment.”
The trial will enroll approximately 1,000 ovarian cancer patients at clinical trial centers in the United States and internationally.
More information about the trial is available at www.clinicaltrials.gov, identifier NCT03522246.