Corcept Therapeutics’ relacorilant, a selective glucocorticoid receptor antagonist (SGRA), is emerging as a novel therapeutic candidate in the treatment of ovarian cancer, an area challenged by limited treatment options due to eventual recurrence and resistance to the mainstay platinum-based chemotherapies. Primary data from the Phase III ROSELLA trial presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held from 30 May to 3 June 2025, suggests that relacorilant may enhance chemotherapy sensitivity and improve outcomes for patients with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer. Notably, relacorilant is the only late-stage SGRA in development for ovarian cancer, positioning it for potential first-to-market status in this therapeutic class.
Relacorilant blocks GR activation, a key pathway driving stress-induced chemoresistance in ovarian cancer cells. Endogenous cortisol activates GR, which triggers the upregulation of anti-apoptotic gene expression that counteracts the effects of cytotoxic chemotherapy. By inhibiting this cortisol-induced resistance mechanism, relacorilant restores the apoptotic potential of cancer cells, thereby enhancing chemotherapy sensitivity.
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In the Phase III ROSELLA trial, patients who received one to three prior lines of systemic therapy were randomised to receive either oral relacorilant with nab-paclitaxel or nab-paclitaxel monotherapy. The trial met both co-primary endpoints of progression-free survival (PFS) and median overall survival (mOS). According to blinded independent central review, PFS was 6.5 months with the relacorilant combination compared to 5.5 months with nab-paclitaxel alone, reflecting a 30% reduction in the risk of progression or death (hazard ratio [HR] 0.70; p=0.0076). A 31% improvement in mOS was also observed in the relacorilant arm of 16.0 months versus 11.5 months with nab-paclitaxel alone (HR 0.69; p=0.0121). Although the OS data is currently at 50% maturity, further follow-up is expected to strengthen the significance of this endpoint. Interestingly, the incidence of ascites, a common and debilitating symptom for patients with advanced-stage ovarian cancer, was lower in patients who received the relacorilant combination, with 5.3% versus 10.5% based on exposure-adjusted incidence rates. In terms of adverse events, the relacorilant and nab-paclitaxel combination was well-tolerated with no new safety signals. Reported adverse events were consistent with the known profile of nab-paclitaxel, and the most common adverse events of neutropenia and anaemia were observed with the combination. Dr Alexander B Olawaiye noted that patients in the relacorilant arm remained on platinum-based therapy 30% longer than those in the control arm. However, when adjusted for this longer exposure, the incidence rate remained comparable between arms.
Relacorilant is unique among investigational agents in ovarian cancer in that it operates with a biomarker-agnostic approach. It has demonstrated activity regardless of tumour GR expression, making it a viable treatment for a broad population, including patients who do not express currently targeted common ovarian cancer biomarkers such as folate receptor-alpha. In addition to its differentiated mechanism of action, relacorilant offers the advantage of oral administration, supporting ease of use in outpatient settings. Relacorilant has also demonstrated the ability to resensitise tumours to platinum-based chemotherapy, potentially extending the duration of benefit from standard-of-care (SOC) treatment. This will address a significant unmet need in patients who have developed resistance. A future trial strategy to expand upon this study includes a platinum rechallenge arm following relacorilant therapy that may offer valuable insight into its ability to extend platinum’s utility and improve long-term outcomes. According to leading data and analytics company GlobalData’s analyst consensus forecast, relacorilant’s total global sales are projected to reach $3.38bn by 2031, contingent on its successful integration into the SOC algorithm, particularly as a second-line or later treatment option. Further data maturity will also play a key role in defining its position within the treatment landscape.
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