Corcept Therapeutics’ pivotal Phase III ROSELLA trial of oral relacorilant in combination with nab-paclitaxel has met its primary endpoint, demonstrating an improvement in progression-free survival (PFS) in individuals with platinum-resistant ovarian cancer.
The trial, which enrolled 381 platinum-resistant ovarian cancer subjects across sites in Argentina, Brazil, Canada, Europe, Australia and South Korea, showed a 30% decrease in the disease progression risk for those treated with the combination therapy against only nab-paclitaxel.
Go deeper with GlobalData
Subjects in the therapy cohort experienced a median PFS of 6.5 months according to the blinded independent central review (BICR) assessment versus 5.5 months for those receiving only nab-paclitaxel.
An interim assessment also revealed an improvement in overall survival (OS), with a median OS of 16.0 months for the combination therapy versus 11.5 months for only nab-paclitaxel.
The therapy’s safety profile was consistent with previous studies, showing good tolerability without any safety concerns.
According to the company, the trial’s dual primary endpoints, PFS-BICR and OS, required only one to be met for a positive result. The outcomes are said to support a new drug application (NDA) in the US and a European marketing authorisation application (MAA).
The trial is being carried out in partnership with the Asia-Pacific Gynecologic Oncology Trials Group, the Australia New Zealand Gynaecological Oncology Group, the European Network of Gynaecological Oncological Trial groups, the GOG Foundation, and the Latin American Cooperative Oncology Group.
Corcept Therapeutics chief development officer Bill Guyer said: “The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer.
“We deeply appreciate the patients and investigators who participated in the trial, and we look forward to presenting the trial’s full results in the coming months.”
Relacorilant is stated to be a selective glucocorticoid receptor (GR) antagonist, modulating the activity of cortisol without affecting other hormone receptors.
The company is exploring the therapy in several serious conditions, including Cushing’s syndrome and prostate cancer.
The therapy secured orphan drug status from both the European Commission (EC) and the US Food and Drug Administration (FDA) for treating hypercortisolism and from the EC for ovarian cancer.
