Clovis Oncology, Inc. announced the completion of target patient enrollment in the Clovis-sponsored 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), as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer. ATHENA is the first front-line switch maintenance study designed to show PARP monotherapy and PARP/PD-1 combination therapy in one study design.
“The completion of target patient enrollment in the Phase 3 ATHENA trial is an important milestone for Clovis and a critical step toward developing additional therapeutic options for women with advanced ovarian cancer,” said Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology. “This was a tremendous effort by trial investigators, our collaborators and our dedicated Clovis team to complete target enrollment in this 1,000-patient study in under two years. Most important, we are grateful to all of the patients who participated in this study.”
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.
Target enrollment for the ATHENA trial was 1,000 ovarian cancer patients. Patients were enrolled at clinical trial centers in 24 countries including North America, Europe and Asia.
Topline data for the Rubraca monotherapy versus placebo arm in all study populations is expected in the second half of 2021 and, if supportive, would serve as the basis of an sNDA for the maintenance treatment of front-line, newly-diagnosed, advanced ovarian cancer patients. Topline data for the combination of Rubraca and Opdivo versus Rubraca monotherapy in all study populations are expected a year or more later and, if supportive, would serve as the basis of an sNDA for the combination therapy in front-line, newly-diagnosed ovarian cancer. In each of these, the primary efficacy analysis will evaluate two prospectively defined molecular sub-groups in a step-down manner: first, HRD-positive patients, including BRCA-mutant patients; and the intent-to-treat population, or all patients treated in ATHENA.