Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, today announced that, following consultation with the U.S. Food and Drug Administration (FDA), it will start a registrational Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer. The company also announced that the positive results from its 178-patient, randomized, controlled, Phase 2 study will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting today.
“We are excited to launch our pivotal Phase 3 trial, which we have named ROSELLA,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Simply replicating the positive results of our Phase 2 study – improvements in progression free survival, duration of response and overall survival without increased side effect burden – will be of unprecedented benefit to women with advanced ovarian cancer, for whom relacorilant plus nab-paclitaxel has the potential to become a new standard of care.”
“The ROSELLA trial design closely tracks the design of our successful Phase 2 study, with adjustments that emerged from constructive conversations with the FDA and leading clinicians from the Gynecological Oncology Group. Based on these conversations, we are confident that positive results in ROSELLA will support a new drug application.”
ROSELLA has a planned enrollment of 360 women, randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel monotherapy. The primary endpoint will be progression free survival, with overall survival as a key secondary endpoint.
All patients will have received prior bevacizumab therapy, which is the current standard of care in the United States for patients with platinum-resistant ovarian cancer. Almost two-thirds of the women enrolled in Corcept’s Phase 2 trial met this criterion. Women with a history of tumors that do not respond at all to initial platinum-based treatments (i.e., women with “primary platinum-refractory” disease) and those who have received more than three prior lines of therapy – both indicators of a very poor prognosis – will be excluded.
Corcept plans to start ROSELLA by the end of this month.