On June 29, 2022 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, reported that it has initiated ROSELLA, a pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, JUN 29, 2022, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-initiates-rosella-pivotal-phase-3-trial [SID1234616364]).
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"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. Additional information about ROSELLA and Corcept’s Phase 2 trial results can be found at the publications and press releases tabs of www.corcept.com.
About Platinum-Resistant Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women.1 Patients whose disease returns less than six months after receiving platinum-containing therapy are described as having "platinum-resistant" disease. In the United States, approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year.2 There are few treatment options and median overall survival following recurrence of disease is 12 months or less with single-agent chemotherapy.3 No approved therapy has been shown to significantly extend overall survival in patients with recurrent, platinum-resistant ovarian cancer compared to standard chemotherapy.4
About Corcept’s Oncology Programs
There is substantial evidence that cortisol activity at the glucocorticoid receptor ("GR") reduces the efficacy of certain anti-cancer therapies and that modulating cortisol’s activity may help anti-cancer treatments achieve their intended effect.
Many types of solid tumors express the GR and are potential targets for cortisol modulation therapy. In some cancers, cortisol inhibits cellular apoptosis – the tumor-killing effect many treatments are meant to stimulate. In other cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response; activating – not suppressing – the immune system is beneficial in fighting certain cancers.
Corcept is conducting clinical trials of its proprietary selective cortisol modulators in combination with three different anti-cancer treatments in patients with ovarian, adrenal and prostate cancers. Corcept’s first controlled study in oncology – relacorilant plus nab-paclitaxel for the treatment of patients with ovarian cancer – has demonstrated statistically significant and clinically meaningful results.
About Relacorilant
Relacorilant is a non-steroidal, selective glucocorticoid receptor modulator that does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian and adrenal cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents, as well as orphan drug designation in the United States for the treatment of pancreatic cancer and both the United States and the European Union for the treatment of Cushing’s syndrome.