Corcept Begins Trial of Relacorilant Combo in Resistant Ovarian Cancer
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage biopharmaceutical company focused on the discovery and development of innovative therapies that modulate the effects of the stress hormone cortisol to treat serious diseases, today announced the initiation of BELLA, a Phase 2 clinical trial investigating the efficacy and safety of its proprietary drug relacorilant in combination with nab-paclitaxel (Abraxane®) and bevacizumab (Avastin®) in patients with platinum-resistant ovarian cancer. This new trial represents a critical step forward in Corcept’s efforts to address urgent unmet needs in the treatment of recurrent, hard-to-treat ovarian malignancies.
BELLA is a multicenter, single-arm, open-label clinical trial that aims to enroll approximately 90 women diagnosed with recurrent platinum-resistant ovarian cancer (PROC) across 50 clinical sites spanning North America, Europe, and the Asia-Pacific region. Participants in the study will receive a combination therapy of relacorilant, nab-paclitaxel, and bevacizumab. The trial’s primary endpoints will assess progression-free survival (PFS), while secondary endpoints will evaluate overall survival (OS), objective response rate (ORR), and the tolerability and safety of the three-drug regimen.
Advancing a New Cortisol-Modulating Treatment Paradigm
Relacorilant is a selective glucocorticoid receptor (GR) antagonist developed by Corcept to counteract the harmful effects of excessive cortisol signaling in various disease states, including certain cancers. Research has shown that cortisol can impair the effectiveness of chemotherapy and promote tumor progression by enhancing tumor cell survival and suppressing anti-tumor immune responses. By blocking cortisol’s activity at the GR, relacorilant has the potential to enhance the efficacy of cytotoxic and anti-angiogenic therapies without adding toxicity.
Previous clinical investigations, including the ROSELLA Phase 3 trial, have already demonstrated the clinical utility of relacorilant in platinum-resistant ovarian cancer when administered with nab-paclitaxel. The results from ROSELLA revealed that patients receiving the relacorilant and nab-paclitaxel combination achieved statistically significant improvements in both progression-free survival and overall survival, compared to historical controls, while maintaining a manageable safety profile.
The addition of bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor A (VEGF-A), into the BELLA treatment regimen is intended to further suppress tumor angiogenesis – a hallmark of ovarian cancer progression. Bevacizumab is already an established component of treatment for certain subsets of PROC, but combining it with relacorilant and nab-paclitaxel may offer synergistic benefits. BELLA is designed to evaluate whether this triplet therapy may deliver a more durable clinical response, especially in a patient population that typically experiences limited treatment success and high recurrence rates.
Addressing a Critical Unmet Need in Ovarian Cancer
Ovarian cancer remains one of the most lethal gynecologic malignancies, with the majority of cases diagnosed at an advanced stage. Despite initial responses to platinum-based chemotherapy, up to 80% of patients eventually relapse, and many become resistant to platinum treatment over time. Once the disease becomes platinum-resistant, treatment options are limited, and the prognosis is often poor, with median survival typically under one year.
Platinum-resistant ovarian cancer is defined as a recurrence that occurs within six months of completing platinum-based chemotherapy. In this setting, therapeutic strategies focus on prolonging survival, delaying disease progression, and preserving quality of life, all while minimizing treatment-related toxicities. Traditional cytotoxic chemotherapies offer limited benefit in this population, prompting a critical need for novel therapeutic approaches.
The BELLA trial represents Corcept’s growing commitment to addressing this clinical challenge by exploring innovative, cortisol-modulating combination therapies that may provide meaningful clinical benefit to women facing this aggressive and refractory form of cancer.
Corcept’s Broader Oncology Pipeline and Cortisol Biology Platform
The initiation of the BELLA trial further solidifies Corcept Therapeutics’ position as a leader in cortisol receptor modulation – a novel and scientifically validated approach to treating a range of diseases characterized by cortisol dysregulation. While relacorilant is currently the most advanced candidate in the company’s oncology pipeline, Corcept is also pursuing investigational programs targeting other cancers such as pancreatic, adrenal, and castration-resistant prostate cancer, in combination with both traditional chemotherapies and novel targeted agents.
Corcept’s proprietary pipeline is built upon more than two decades of clinical and translational research into the role of the glucocorticoid receptor in health and disease. By selectively inhibiting the GR without affecting other steroid hormone receptors, relacorilant avoids the side effects associated with general corticosteroid blockade. This high degree of selectivity and safety enables its use in combination with existing cancer therapies – potentially enhancing their efficacy while reducing toxicity.
Corcept is also advancing relacorilant and other GR antagonists for indications beyond oncology, including Cushing’s syndrome, metabolic disorders, and neurological conditions, reflecting the broad therapeutic utility of its platform.
Trial Execution and Future Milestones
With patient enrollment for the BELLA study now underway, Corcept anticipates initiating trial sites globally throughout the second and third quarters of 2025. Interim analyses are expected in late 2026, with top-line data potentially available by 2027, depending on recruitment and event rates.
The company also continues to engage with global regulatory agencies, clinical experts, and patient advocacy organizations to ensure the trial’s design and execution reflect current standards of care and patient priorities.
