- Relacorilant plus nab-paclitaxel improved progression-free survival (PFS), duration of response (DoR) and overall survival (OS), without increasing side effects, compared to nab-paclitaxel monotherapy
- Confirmatory Phase 3 ROSELLA trial underway, with planned enrollment of 360 patients in the United States, Europe, Canada, Israel, Asia and South America
MENLO PARK, Calif., June 27, 2023 (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 publication of the final analysis from its Phase 2 trial evaluating its proprietary cortisol modulator, relacorilant, in women with platinum-resistant ovarian cancer in the Journal of Clinical Oncology (JCO), the premiere journal of the American Society of Clinical Oncology (ASCO).
The publication is titled Relacorilant + Nab-Paclitaxel in Patients with Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study and can be accessed at the following link: https://ascopubs.org/doi/full/10.1200/JCO.22.02624
In the trial, patients who received relacorilant orally the day before, the day of and the day after their nab-paclitaxel infusion (“intermittent dosing”) experienced a 34 percent reduction in risk of disease progression (median PFS=5.6 vs. 3.8 months, HR 0.66, P=0.038), responded to treatment longer (median DoR=5.6 vs. 3.7 months, HR 0.36, P=0.006) and had a 33 percent reduction in risk of death (median OS=13.9 vs. 12.2 months, HR 0.67, P=0.066) compared to patients who received nab-paclitaxel alone. Adverse events were comparable across the study arms.
PFS and OS benefits were exhibited across multiple subgroups of patients. Patients who would have met the eligibility requirements for Corcept’s confirmatory Phase 3 ROSELLA trial did especially well. A post-hoc analysis showed that patients who had received prior bevacizumab, did not have primary platinum-refractory disease and who had received no more than three prior lines of therapy experienced a 62 percent reduction in risk of death (median OS=17.9 vs. 12.6 months, HR 0.38, P=0.011) compared to similar patients who received nab-paclitaxel alone.
“Outcomes for patients with platinum-resistant ovarian cancer are poor and treatment options are limited,” said first author of the publication Nicoletta Colombo, MD, PhD, Associate Professor, Obstetrics and Gynecology, University of Milan-Bicocca, Director, Ovarian Cancer Center, and Chair, Program of Gynecology, European Institute of Oncology, IRCCS, Milan Italy. “The benefits experienced by patients in the intermittent dosing group are meaningful especially given the simple, oral dosing and favorable safety profile of relacorilant. We are on the cusp of developing an entirely new way to treat this serious disease.”
“We are excited by the data from our Phase 2 trial and enthusiastic the results have been published in the Journal of Clinical Oncology. Our single goal is to replicate the great results seen in our phase 2 trial,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We believe relacorilant has the potential to become a new standard of care for all patients with platinum-resistant ovarian cancer.”
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 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. There are few treatment options and median overall survival following recurrence of disease is typically 12 months or less with single-agent chemotherapy.
About Corcept’s Oncology Programs
There is substantial evidence that cortisol activity at the glucocorticoid receptor (“GR”) allows certain solid tumors to resist treatment 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.
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, adrenal and prostate 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.
About Corcept Therapeutics
Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol and owns extensive United States and foreign intellectual property covering both their composition and their use to treat a variety of serious disorders. Clinical trials are being conducted with the company’s leading selective cortisol modulators as potential treatments for patients with serious disorders – Cushing’s syndrome, ovarian, prostate and adrenal cancer, ALS, post-traumatic stress disorder and liver disease. Corcept’s drug Korlym® was the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing’s syndrome.
Forward Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business, conduct our clinical trials and achieve our other goals during the COVID-19 pandemic; risks related to the development of relacorilant and other product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website.
In this press release, forward-looking statements include those concerning the development of relacorilant as a treatment for ovarian cancer, including its clinical attributes, regulatory approvals, mandates, oversight, and other requirements; the potential for relacorilant plus nab-paclitaxel to become a standard of care for patients with recurrent platinum-resistant ovarian cancer; and our Phase 3 ROSELLA trial. We disclaim any intention or duty to update forward-looking statements made in this press release.
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