Corcept Presents Pivotal Clinical Data in ASCO Late-Breaker with Simultaneous Publication in The Lancet: Relacorilant Improves Progression-Free and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer
- Relacorilant plus nab-paclitaxel improves progression-free and overall survival in patients with platinum-resistant ovarian cancer, with no need for biomarker selection
- Addition of relacorilant did not increase side-effects, compared to nab-paclitaxel monotherapy
- Results presented in late-breaking podium presentation at ASCO 2025 with simultaneous publication in The Lancet
The presentation abstract can be found here and the presentation slides here. The data have been simultaneously published in The Lancet, titled “Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial.”
ROSELLA met its primary endpoint of improved progression-free survival as assessed by blinded independent central review (PFS-BICR). Patients who received relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients who received nab-paclitaxel monotherapy (hazard ratio: 0.70; p-value: 0.0076). Median PFS-BICR was extended to 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone. In addition, PFS assessed by investigators was consistent with PFS-BICR, with a hazard ratio of 0.71 (p-value: 0.0030). An interim analysis of overall survival (OS), showed that the addition of relacorilant reduced the risk of death by 31 percent, substantially lengthening patients’ lives. Median OS for patients who received relacorilant was 16.0 months, compared to 11.5 months for patients who received nab-paclitaxel alone (hazard ratio: 0.69; p-value: 0.0121). These benefits were seen in all clinically relevant subgroups, including those with poor prognoses.
Relacorilant plus nab-paclitaxel was well-tolerated, with a comparable safety profile between treatment arms. The addition of relacorilant did not increase patients’ safety burden. In addition, patients treated with relacorilant plus nab-paclitaxel had a lower incidence of ascites (5.3 percent), than did patients who received nab-paclitaxel alone (10.5 percent). The occurrence of abdominal paracenteses during treatment was also lower for patients treated with relacorilant plus nab-paclitaxel (7.4 percent), compared to nab-paclitaxel alone (13.2 percent).
“For many patients with advanced, recurrent ovarian cancer, the tumor eventually becomes resistant to chemotherapy, and oncologists have few good treatment options. Relacorilant plus nab-paclitaxel may provide a powerful tool for improving progression-free and overall survival in patients with this disease,” said Alexander B. Olawaiye, M.D., Director of gynecological cancer research at Magee-Women’s Hospital of the University of
“These data show that treatment with relacorilant can help patients with platinum-resistant ovarian cancer live longer, without adding to their safety burden. We plan to bring this treatment option to patients as quickly as possible and are working on our regulatory applications in the
ROSELLA enrolled 381 patients with platinum-resistant ovarian cancer at sites in
The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG), and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).
About Relacorilant
Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of 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 have “platinum-resistant” disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in
About Cortisol’s Role in Oncology
Cortisol plays a role in tumor growth through several mechanisms: It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.
About Corcept Therapeutics
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the
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 and 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 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 statements concerning: the results of our ROSELLA and BELLA trials; relacorilant’s efficacy, safety and other clinical attributes and its potential to receive regulatory approval and become a standard-of-care treatment for patients with platinum-resistant ovarian cancer; regulatory oversight of relacorilant and the scope, pace and outcome of potential NDA and MAA submissions; relacorilant’s acceptance and use by physicians and patients and its commercial prospects; the likelihood of Corcept undertaking or completing other clinical trials and their outcomes; and the scope and protective power of relacorilant’s orphan drug designation and our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
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