Corcept Completes Enrollment in Pivotal Phase 3 Rosella Trial of Relacorilant in Patients With Platinum-Resistant Ovarian Cancer

MENLO PARK, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in ROSELLA, a pivotal Phase 3 trial of its proprietary selective cortisol modulator relacorilant combined with nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer.

“Fully enrolling ROSELLA takes us a big step closer to addressing the unmet medical need of women with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Relacorilant has the potential to become the standard of care for patients with this devastating disease. We expect progression-free survival data, ROSELLA’s primary endpoint, by the end of this year.”

The ROSELLA trial has the same design as Corcept's positive Phase 2 study, in which patients who received relacorilant intermittently – the day before, the day of and the day after they received nab-paclitaxel – exhibited improvements in progression-free survival, duration of response and overall survival compared to patients who received nab-paclitaxel alone, without an increased side effect burden. These results were published in the Journal of Clinical Oncology in June 2023.

The ROSELLA trial enrolled 381 women at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Patients were randomized 1:1 to receive either relacorilant dosed intermittently with nab-paclitaxel or nab-paclitaxel monotherapy. ROSELLA’s primary endpoint is progression-free survival. Overall survival is a key secondary endpoint.

About Platinum-Resistant Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have “platinum-resistant” disease. There are few treatment options and median overall survival following recurrence is 12 months or less with single-agent chemotherapy.¹ In the United States, approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year.