## Corcept's Relacorilant Combination Therapy Advances to Phase 3 in Ovarian Cancer Treatment

### Promising Phase 2 Data Supports Move Toward Pivotal Trial Registration

Corcept Therapeutics has announced a significant milestone in its oncology development pipeline: the company will initiate a pivotal Phase 3 trial of relacorilant combined with nab-paclitaxel targeting patients diagnosed with recurrent platinum-resistant ovarian cancer. The decision follows comprehensive consultations with the U.S. Food and Drug Administration and builds on encouraging results from earlier-stage investigations.

The upcoming trial, designated ROSELLA, marks a critical step toward potential regulatory approval and commercialization of this therapeutic approach. According to Corcept's Chief Development Officer, the design has been carefully calibrated to replicate the positive signals observed in the preceding Phase 2 study while incorporating feedback from FDA leadership and leading academic oncologists specializing in gynecological malignancies.

### Phase 2 Evidence Demonstrates Clinical Benefit

Data from Corcept's Phase 2 investigation, which enrolled 178 patients in a randomized controlled design, revealed substantial clinical advantages for the combination regimen. Among the subset of patients who would be eligible for ROSELLA enrollment and received relacorilant using the intermittent dosing schedule planned for the larger trial, results showed meaningful improvements across multiple efficacy measures.

Median progression-free survival extended to 7.3 months in the relacorilant combination arm compared to 3.7 months in the control group—representing a hazard ratio of 0.40 (95% confidence interval: 0.21-0.77; p=0.005). Duration of response similarly showed improvement, with a median of 5.6 months versus 3.1 months in comparators (hazard ratio 0.29; p=0.016).

Most notably, median overall survival reached 17.9 months with the investigational combination versus 12.6 months for nab-paclitaxel monotherapy (hazard ratio 0.38; p=0.011). The improvements occurred without increasing the frequency or severity of adverse events, suggesting a favorable safety profile.

### ROSELLA Trial Framework and Patient Population

The Phase 3 investigation will randomize approximately 360 women in a 1:1 allocation to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. Progression-free survival has been designated as the primary efficacy endpoint, with overall survival tracked as a key secondary outcome.

Importantly, all enrolled patients must have previously received bevacizumab therapy, reflecting current standard-of-care treatment algorithms in the United States for this patient population. The study will exclude women with primary platinum-refractory disease or those who have received more than three prior treatment lines—both markers associated with particularly unfavorable prognoses.

### Mechanism of Action and Therapeutic Rationale

Relacorilant functions as a selective, non-steroidal glucocorticoid receptor modulator that does not interact with other hormone receptor systems. The mechanistic rationale underlying this approach centers on the hypothesis that cortisol activity can diminish the effectiveness of certain anticancer therapies. In numerous malignancies, glucocorticoid signaling can suppress apoptotic pathways that chemotherapy seeks to activate, while simultaneously dampening immune surveillance—a disadvantage in malignancies where immune activation is beneficial.

By selectively modulating cortisol effects at the glucocorticoid receptor without systemic hormonal disruption, relacorilant may enhance chemotherapy efficacy and immune function, thereby improving clinical outcomes.

### Disease Context and Medical Need

Platinum-resistant ovarian cancer represents a particularly challenging clinical scenario. Defined as disease recurring within six months of platinum-based chemotherapy completion, this condition affects approximately 20,000 women annually in the United States who become candidates for new therapeutic interventions. Current treatment landscape offers limited options; single-agent chemotherapy yields median overall survival of 12 months or less following recurrence.

To date, no approved therapeutic agent has demonstrated substantial overall survival benefit compared to standard chemotherapy in this patient population, underscoring the significant unmet medical need and the potential importance of novel approaches like the relacorilant combination.

### Development Timeline and Next Steps

Corcept indicated plans to commence ROSELLA enrollment by month-end. The trial design closely mirrors the Phase 2 investigation while incorporating modifications developed through collaborative discussions with regulatory authorities and leading gynecological oncology specialists. This alignment is expected to strengthen the likelihood that positive ROSELLA outcomes will support a comprehensive new drug application submission.

The company continues developing relacorilant across multiple oncologic indications and patient populations, with additional clinical programs underway in adrenal cancer and prostate cancer. Earlier approvals, including Korlym for Cushing's syndrome, have established the company's expertise in glucocorticoid receptor modulation as a therapeutic strategy across diverse endocrine and neoplastic disorders.