Corcept Completes Enrollment in Pivotal Phase 3 Rosella Trial of Relacorilant in Patients With Platinum-Resistant Ovarian Cancer
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Insights
The completion of enrollment in the ROSELLA Phase 3 trial by Corcept Therapeutics represents a significant milestone in the development of relacorilant for the treatment of platinum-resistant ovarian cancer. The data from this study is particularly relevant as it addresses an area with a high unmet medical need. The previous Phase 2 study results, which showed improved outcomes for patients without increasing side effects, suggest that relacorilant could indeed offer a new therapeutic option for patients.
From a clinical research perspective, the trial's design mirrors the successful Phase 2 study, which could increase confidence in the potential for positive outcomes. However, the real test will come with the progression-free survival data expected later this year. If the data is favorable, it could lead to a new standard of care in this patient population.
For investors, the focus should be on the forthcoming data release, as it will likely have a significant impact on Corcept's valuation. Positive results could lead to an increase in stock value, while any setbacks might have the opposite effect. It is also worth noting that the international scope of the trial could facilitate global regulatory submissions and commercialization, potentially expanding the market reach of relacorilant.
Ovarian cancer treatments represent a market with significant growth potential, especially in the segment of platinum-resistant cases where treatment options are limited. Corcept's strategic focus on this niche is a savvy move, potentially allowing them to command a premium price for relacorilant if approved. The market dynamics in oncology favor innovative treatments that can demonstrate clear benefits in terms of survival or quality of life.
Looking at the broader implications, the successful development of relacorilant could also enhance Corcept's reputation as a leader in modulating cortisol effects, potentially opening doors to other indications and collaborations. Investors should monitor Corcept's commercial strategy closely, including partnerships for distribution or co-marketing, which could significantly affect the speed and extent of market penetration.
Finally, it's important to consider the competitive landscape. Any emerging treatments from competitors that could potentially overshadow relacorilant's benefits would be a risk factor. Keeping an eye on the development pipeline of other companies in this space is essential for a comprehensive market analysis.
MENLO PARK, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in ROSELLA, a pivotal Phase 3 trial of its proprietary selective cortisol modulator relacorilant combined with nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer.
“Fully enrolling ROSELLA takes us a big step closer to addressing the unmet medical need of women with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Relacorilant has the potential to become the standard of care for patients with this devastating disease. We expect progression-free survival data, ROSELLA’s primary endpoint, by the end of this year.”
The ROSELLA trial has the same design as Corcept's positive Phase 2 study, in which patients who received relacorilant intermittently – the day before, the day of and the day after they received nab-paclitaxel – exhibited improvements in progression-free survival, duration of response and overall survival compared to patients who received nab-paclitaxel alone, without an increased side effect burden. These results were published in the Journal of Clinical Oncology in June 2023.
The ROSELLA trial enrolled 381 women at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Patients were randomized 1:1 to receive either relacorilant dosed intermittently with nab-paclitaxel or nab-paclitaxel monotherapy. ROSELLA’s primary endpoint is progression-free survival. Overall survival is a key secondary endpoint.
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 have “platinum-resistant” disease. There are few treatment options and median overall survival following recurrence is 12 months or less with single-agent chemotherapy.1 In the United States, approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year.
About Relacorilant
Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor (GR), but 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, method of use and other patents.
About Corcept’s Oncology Programs
Cortisol activity allows solid tumors that express the GR to resist treatment. 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, weakening the body’s ability to fight certain cancers. Modulating cortisol’s activity may reduce these adverse effects and help anti-cancer treatments achieve their intended effect.
Corcept is conducting clinical trials of its proprietary compound, relacorilant, in combination with three different anti-cancer treatments in patients with ovarian, adrenal and prostate cancers.
About Corcept Therapeutics
For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients across a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept’s advanced clinical trials are being conducted in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS) and liver disease (NASH). In February 2012, the company introduced Korlym, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing’s syndrome. Corcept is headquartered in Menlo Park, California. For more information, visit Corcept.com.
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; risks related to the study and development of Korlym as well as relacorilant, miricorilant, dazucorilant and our 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 conduct, pace and outcome of our Phase 3 ROSELLA trial in patients with ovarian cancer, as well as the development of relacorilant as a treatment for other solid tumors, Cushing’s syndrome and other indications, including relacorilant’s 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 or to otherwise meet their unmet medical needs. We disclaim any intention or duty to update forward-looking statements made in this press release.
1 Therapeutic Advances in Medical Oncology (Luvero et al. 2014)
CONTACT
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FAQ
What is the purpose of the ROSELLA trial conducted by Corcept Therapeutics (CORT)?
What were the key findings from Corcept's positive Phase 2 study that influenced the design of the ROSELLA trial?
How many women were enrolled in the ROSELLA trial, and where were the sites located?
What are the primary and key secondary endpoints of the ROSELLA trial?
