Corcept Therapeutics Initiates ROSELLA – A Pivotal Phase 3 Trial in Recurrent, Platinum-Resistant Ovarian Cancer

Phase 2 trial showed that relacorilant plus nab-paclitaxel improved progression-free survival, duration of response and overall survival without an increased side effect burden compared to nab-paclitaxel alone

Excerpt from the Press Release:

MENLO PARK, Calif., June 29, 2022 (GLOBE NEWSWIRE) — 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 it has initiated ROSELLA, a pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer.

“We are excited that our ROSELLA study is now open,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “The 20,000 women in the United States and an equal number in Europe with platinum-resistant ovarian cancer have few good treatment options. Our Phase 2 study demonstrated improvements in progression free survival, duration of response and overall survival without increased side effect burden. Our goal in Phase 3 is to replicate these positive results, which would be of unprecedented benefit to women with platinum-resistant ovarian cancer, for whom relacorilant plus nab-paclitaxel has the potential to become a new standard of care.”

ROSELLA has a planned enrollment of 360 women with recurrent, platinum-resistant ovarian cancer, 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. The ROSELLA trial design closely tracks the design of Corcept’s successful Phase 2 study.

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