Relacorilant Plus Nab-Paclitaxel Significantly Improves Survival in PROC

Full results from the phase 3 ROSELLA trial (NCT05257408) were shared at the 27th European Congress on Gynaecological Oncology (ESGO).¹ As previously reported, relacorilant plus nab-paclitaxel (Abraxane) significantly improved overall survival (OS) and progression-free survival (PFS) vs nab-paclitaxel alone in patients with platinum-resistant ovarian cancer.

In the analysis of the dual primary end points, the addition of relacorilant to nab-paclitaxel resulted in a 31% reduction in the risk of death compared to nab-paclitaxel monotherapy, with a median OS of 15.97 months (95% CI, 13.47-not reached [NR]) compared with 11.50 months (95% CI, 10.02-13.57), respectively (HR, 0.69; 95% CI, 0.52-0.92; P = .0121). At the time of this report, OS was 50% mature. The trial also met the primary end point of PFS as assessed by blinded independent central review, showing a median PFS of 6.54 months (95% CI, 5.55-7.43) for the combination arm vs 5.52 months (95% CI, 3.94-5.88) for the control arm (HR, 0.70; 95% CI, 0.54-0.91; P = .0076).

Subgroup analyses further validated these results, particularly in patients who had previously progressed on a PARP inhibitor, where the combination yielded a median PFS of 7.36 months (95% CI, 5.39-8.44) compared with 3.94 months (95% CI, 3.32-5.72) for monotherapy (HR, 0.56; 95% CI, 0.37-0.84; P = .0046). In this specific subgroup, the investigator-assessed objective response rate (ORR) was 34.9% for the combination vs 26.8% for the monotherapy. Among patients 65 years or older, the median PFS was 7.39 months (95% CI, 5.82-11.76) with relacorilant plus nab-paclitaxel compared with 5.85 months (95% CI, 4.17-7.29) with nab-paclitaxel alone (HR, 0.61; 95% CI, 0.40-0.94; P = .0247).

The ROSELLA trial was a randomized, open-label, study that enrolled 381 patients across 117 international sites. Eligible patients were required to have epithelial ovarian, primary peritoneal, or fallopian tube cancer with disease progression occurring within 6 months of their last platinum therapy dose. Patients must have had 1 to 3 prior lines of therapy, prior bevacizumab (Avastin) exposure, and an ECOG performance status of 0 or 1.

In the experimental arm, patients received 150 mg of oral relacorilant in combination with 80 mg/m² of intravenous nab-paclitaxel on days 1, 8, and 15 of a 28-day cycle. The control arm received 100 mg/m² of nab-paclitaxel monotherapy on the same schedule.

The dual primary end points were PFS by RECIST v1.1 criteria per blinded independent central review and OS. Secondary end points included PFS by RECIST v1.1 criteria per investigator assessment, ORR, and safety.

The safety profile of the relacorilant combination was comparable to that of nab-paclitaxel monotherapy, with relacorilant adding no additional safety burden. Grade 3 or higher treatment-emergent adverse events occurred in 74.5% of the combination group vs 59.5% in the control group, while serious adverse events were reported in 35.1% and 23.7% of patients, respectively. Notably, the incidence of liver function test abnormalities was lower in the combination arm, with alanine aminotransferase or aspartate aminotransferase increases reported in 5% of patients compared with 9% in the monotherapy arm. There were no relacorilant-related fatal adverse events observed during the study.

The meeting of the OS end point was previously reported in a press release in January 2026.² Furthermore, the FDA accepted a new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer in September 2025.³

Prior regulatory decisions have underscored the clinical potential of the treatment, as relacorilant had received orphan drug designation from the European Commission for the treatment of ovarian cancer. The combination is currently under active review by global health authorities, with a new drug application currently before the FDA and a marketing authorization application under review by the European Medicines Agency. The FDA has assigned a Prescription Drug User Fee Act target action date of July 11, 2026.

References

1. Lorusso D, Quesada S, Chan JK, et al. ROSELLA: A phase 3 study of relacorilant + nab-paclitaxel in patients with platinum-resistant ovarian cancer. Presented at the ESGO 2026 Congress; February 26-28, 2026; Copenhagen, Denmark.
2. Overall survival primary endpoint met in Corcept’s pivotal phase 3 ROSELLA trial of relacorilant in patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics Inc. January 22, 2026. Accessed February 26, 2026. https://tinyurl.com/4vms3yvm
3. FDA files Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics Inc. September 10, 2025. Accessed February 26, 2026. https://tinyurl.com/5yx7cbsp