Relacorilant Shows Benefit in Platinum-Resistant Ovarian Cancer Post-PARP Inhibitor: Corcept ESMO 2025 Late-Breaker

10/19/2025 – 05:15 AM

• New data from pivotal Phase 3 ROSELLA trial reinforce relacorilant plus nab-paclitaxel improves progression-free and overall survival in patients with platinum-resistant ovarian cancer, with no need for biomarker selection – including in people who progressed while on or after taking a PARP inhibitor, a patient population with particularly poor prognosis

• Corcept expands BELLA trial to three study arms: (i) platinum-resistant ovarian cancer, (ii) platinum-sensitive ovarian cancer and (iii) endometrial cancer

REDWOOD CITY, Calif. – Corcept Therapeutics (CORT), a biopharmaceutical firm focusing on cortisol modulation to address severe endocrinologic, oncologic, metabolic, and neurologic conditions, presented compelling new findings from its Phase 3 ROSELLA trial at the European Society for Medical Oncology (ESMO) 2025 Annual Meeting. The ROSELLA trial assessed the efficacy of relacorilant in combination with nab-paclitaxel in patients with platinum-resistant ovarian cancer.

The data revealed a significant progression-free survival (PFS) advantage for patients who had previously progressed on or following PARP inhibitor (PARPi) therapy. This patient subgroup typically faces a grim prognosis. The trial results indicate potential for relacorilant to overcome chemotherapy resistance in PARPi subgroups. Specifically, relacorilant plus nab-paclitaxel demonstrated a PFS benefit in patients with prior PARPi treatment (hazard ratio: 0.60; p-value: 0.0035) and those whose disease progressed while on a PARPi (hazard ratio: 0.56; p-value: 0.0046), with a median PFS of 7.36 months for both subgroups.

Importantly, the combination therapy exhibited a favorable safety profile. The adverse events observed in the relacorilant plus nab-paclitaxel arm were comparable to those in the nab-paclitaxel monotherapy arm, suggesting that relacorilant did not exacerbate the safety burden for patients.

“These new ROSELLA data substantiate the significant benefit of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer, an extremely difficult-to-treat cancer,” commented Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and Full Professor of Obstetrics and Gynaecology, Humanitas University, Rozzano, European Network of Gynaecological Oncological Trial groups Principal Investigator in the ROSELLA trial and ESMO presenter.

In addition to the ROSELLA data, Corcept announced an expansion of its Phase 2 BELLA trial. The BELLA trial will now encompass three study arms evaluating the safety and efficacy of: (i) relacorilant plus nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer; (ii) relacorilant plus nab-paclitaxel and bevacizumab in patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARPi; and (iii) relacorilant plus nab-paclitaxel in patients with endometrial cancer who have received one or two prior lines of therapy. Initial results are anticipated in late 2026.

“The ROSELLA data give us confidence to expand the BELLA trial to include patients with ovarian cancer whose disease is platinum sensitive (an earlier stage of tumor progression), as well as patients with endometrial cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “With the FDA’s recent acceptance of our New Drug Application for relacorilant in platinum-resistant ovarian cancer and the expansion of our BELLA trial, we are closer than ever to bringing new and vital treatment to patients in need. We are grateful to all the patients and investigators for participating in our ongoing trials.”

The ROSELLA trial’s success in meeting its primary endpoint of improved PFS without the need for biomarker selection underscores the potential broad applicability of relacorilant in this patient population. An interim analysis of overall survival (OS) further bolstered this outlook, demonstrating a 31 percent reduction in the risk of death with the addition of relacorilant (hazard ratio: 0.69; p-value: 0.0121), signaling a potentially significant impact on patient longevity.

Relacorilant, an oral selective glucocorticoid receptor (GR) antagonist, functions by modulating cortisol activity without affecting other hormone receptors. Corcept is actively investigating relacorilant’s potential in treating various serious disorders, including endogenous hypercortisolism, ovarian cancer, and prostate cancer. The FDA has granted relacorilant a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025, for hypercortisolism, and a PDUFA date of July 11, 2026, for platinum-resistant ovarian cancer.

From a strategic perspective, Corcept’s focus on cortisol modulation presents both opportunities and challenges. Cortisol’s role in tumor growth and resistance to chemotherapy is increasingly recognized, positioning relacorilant as a potentially valuable addition to existing treatment paradigms. The competitive landscape, however, is evolving, with other companies exploring alternative approaches to target the tumor microenvironment and enhance chemotherapy efficacy. Corcept’s ability to demonstrate a clear clinical benefit and differentiate relacorilant from other emerging therapies will be crucial for its long-term success.

The impact of these results could extend beyond ovarian cancer, potentially influencing treatment strategies for other solid tumors where cortisol plays a significant role. Corcept’s ongoing clinical trials will further illuminate the full potential of relacorilant and its contribution to improved patient outcomes in oncology and beyond.

Source: Corcept Therapeutics Incorporated