Clovis Oncology Inc. (NASDAQ:CLVS) has announced that it has completed the target enrolment of patients in its third phase ATHENA study.
Clovis to evaluate the combination of Rubraca and OPDIVO
The study will evaluate the combination of its poly polymerase inhibitor (PARP), Rubraca (rucaprib) with OPDIVO (nivolumab), which is a PD-1 inhibitor from Bristol-Myers Squibb. The company is evaluating the combination as frontline maintenance therapy for newly detected progressive ovarian cancer treatment. ATHENA will be the first frontline maintenance treatment study that has been designed to demonstrate PARP/PD-1 combination therapy and PARP monotherapy in a single study design.
Patrick Mahaffy, the CEO and President of Clovis Oncology, indicated that the completion of target enrolment in the third phase ATHENA study was a huge milestone for the company. He added that this was a step toward developing more therapeutic alternatives for women dealing with advanced ovarian cancer. Mahaffy stated that the company’s trial investigators, collaborators, and dedicated Clovis team had done a wonderful job in completing the enrolment. They enrolled around 1,000 patients in the trial in less than two years.
The primary endpoint of ATHENA study will be PFS
ATHENA is a third phase multinational, randomized, placebo-controlled, double-blind, randomized, four-arm study. The study is for evaluating the combination of Rubraca and OPDIVO as a frontline response maintenance treatment for patients with newly diagnosed ovarian cancer. The study will analyze the treatment response based on the homologous recombination of tumor sample status. The primary endpoint will be progression-free survival, while secondary endpoints will include objective response rate, overall survival, safety, and duration of response.
The target patient enrolment for the study was 1,000 advanced ovarian cancer patients. The company enrolled the patients in clinical study sites across 24 countries in Europe, Asia, and North America. Clovis Oncology expects to release topline results for Rubraca monotherapy against the placebo arm in the second half of next year. If the data will be encouraging, it will form the basis for an sNDA for frontline maintenance treatment in the advanced ovarian cancer patient.