On June 6, 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, 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 (Press release, Corcept Therapeutics, JUN 6, 2022, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-start-phase-3-trial-relacorilant-plus-nab [SID1234615612]). 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) (Free ASCO Whitepaper) Annual Meeting today.

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"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.

In Corcept’s Phase 2 trial, women who met the entry criteria for ROSELLA and received relacorilant exhibited substantial benefit, without increasing the frequency or severity of adverse events. Results for patients who received relacorilant at the time they received nab-paclitaxel – the "intermittent" dosing regimen that will be used in ROSELLA – are set forth in Table 1.

Phase 2 Trial Results (ROSELLA Patient Population)
Relacorilant +
Nab-paclitaxel
n=25 Comparator
n=31 Hazard Ratio
(95% CI)
Progression-Free Survival
(median) 7.3 months 3.7 months 0.40 (0.21, 0.77); p = 0.005
Duration of Response
(median) 5.6 months 3.1 months 0.29 (0.09, 0.99); p = 0.016
Overall Survival
(median) 17.9 months 12.6 months 0.38 (0.17, 0.82); p = 0.011
Table 1: Results for women in the intermittent and comparator arms of the Phase 2 trial who met the ROSELLA entry criteria.

The Kaplan-Meyer curve showing the survival benefit experienced by women in the Phase 2 trial’s intermittent arm and who met the ROSELLA entry criteria is set forth in Figure 1.

Figure 1

ASCO Oral Presentation

Results from the company’s Phase 2 study in patients with recurrent, platinum-resistant ovarian cancer will be featured in an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting today. Presentation slides are available at www.corcept.com/research-pipeline/publications.

Presentation Title: "Overall survival data from a 3-arm, randomized, open-label, phase 2 study of relacorilant, a selective glucocorticoid receptor modulator, combined with nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer."

Speaker: Dr. Nicoletta Colombo; University of Milan-Bicocca and European Institute of Oncology, IRCCS

Presentation Time / Location: Monday, June 6, 2022, 9:00 AM – 9:12 AM CDT / E450

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.