Trial to Evaluate the Combination of Rubraca® (rucaparib) and OPDIVO® (nivolumab) in Patients with Advanced Ovarian Cancer
BOULDER, CO, USA I August 8, 2018 I Clovis Oncology, Inc. (NASDAQ: CLVS) announced today 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, M.D., FACS, FACOG, Arizona Oncology (US Oncology Network), Professor, Gynecologic Oncology at University of Arizona and Creighton University, Medical Director of US Oncology Research Gynecology program in Phoenix, Arizona 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. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. The primary endpoint is investigator assessed progression-free survival (PFS); secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety.
“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. We are particularly excited about the potential clinical utility of Rubraca in combination with Opdivo in this setting,” said Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology. “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.
About Rubraca® (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and Europe.
Rubraca EU Authorized Use
Rubraca is licensed 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.
Click here to access the current Summary of Product Characteristics. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.
Rubraca U.S. FDA Approved Indications and Important Safety Information
Rubraca is indicated as monotherapy for the 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.
Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK. Please visit clovisoncology.com for more information.
SOURCE: Clovis Oncology
Post Views: 38
Trial to Evaluate the Combination of Rubraca® (rucaparib) and OPDIVO® (nivolumab) in Patients with Advanced Ovarian Cancer
BOULDER, CO, USA I August 8, 2018 I Clovis Oncology, Inc. (NASDAQ: CLVS) announced today 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, M.D., FACS, FACOG, Arizona Oncology (US Oncology Network), Professor, Gynecologic Oncology at University of Arizona and Creighton University, Medical Director of US Oncology Research Gynecology program in Phoenix, Arizona 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. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. The primary endpoint is investigator assessed progression-free survival (PFS); secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety.
“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. We are particularly excited about the potential clinical utility of Rubraca in combination with Opdivo in this setting,” said Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology. “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.
About Rubraca® (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and Europe.
Rubraca EU Authorized Use
Rubraca is licensed 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.
Click here to access the current Summary of Product Characteristics. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.
Rubraca U.S. FDA Approved Indications and Important Safety Information
Rubraca is indicated as monotherapy for the 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.
Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK. Please visit clovisoncology.com for more information.
SOURCE: Clovis Oncology
Post Views: 38
