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Relacorilant plus nab-paclitaxel (Abraxane) produced a progression-free survival (PFS) benefit vs nab-paclitaxel alone in a subgroup of patients with platinum-resistant ovarian cancer (PROC) who had received prior PARP inhibitor treatment, including those who had progressed during PARP inhibitor treatment, according to findings from a pre-planned subgroup analysis of the phase 3 ROSELLA trial (NCT05257408), which were presented at the 2025 ESMO Congress.¹

In the subgroup of patients who had prior exposure to a PARP inhibitor, relacorilant plus nab-paclitaxel (n = 114) elicited a median blinded independent central review (BICR)–assessed PFS of 7.36 months (95% CI, 5.59-8.18) vs 4.63 months (95% CI, 3.55-5.72) with nab-paclitaxel alone (n = 120; HR, 0.60; 95% CI, 0.42-0.85; nominal P = .0035). The investigator-assessed overall response rates (ORRs) in these respective groups were 39.5% and 30.8%.

Furthermore, in the subgroup of patients who had progressed on a prior PARP inhibitor, the BICR-assessed median PFS with relacorilant plus nab-paclitaxel (n = 86) was 7.36 months (95% CI, 5.39-8.44) vs 3.94 months (95% CI, 3.32-5.72) with nab-paclitaxel alone (n = 97; HR, 0.56; 95% CI, 0.37-0.84; nominal P = .0046). The investigator-assessed ORRs in these respective groups were 34.9% and 26.8%.

“Consistent benefit was reported in this subgroup analysis in PARP [inhibitor]–pretreated patients [with] relacorilant plus nab-paclitaxel,” presenting author Domenica Lorusso, MD, PhD, said.

Lorusso is director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, as well as a full professor of obstetrics and gynecology at Humanitas University, Rozzano, in Milan, Italy.

What Were the Rationale and Design of the ROSELLA Trial?

Ovarian cancers harbor glucocorticoid receptor expression, which is a marker of poor prognosis. Relacorilant is a novel, selective glucocorticoid receptor antagonist that restores cancer sensitivity to cytotoxic chemotherapy.

ROSELLA enrolled patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer who had an ECOG performance status of 0 or 1, had progressed less than 6 months after their last dose of platinum therapy, and had received 1 to 3 prior lines of therapy, including prior bevacizumab. Patients were randomly assigned 1:1 to receive nab-paclitaxel at 80 mg/m² on days 1, 8, 15 of each 28-day cycle, in combination with relacorilant at 150 mg on the day before, the day of, and the day after nab-paclitaxel infusion; or nab-paclitaxel monotherapy at 100 mg/m² on the same nab-paclitaxel dosing schedule.

PFS by BICR and overall survival (OS) served as the dual primary end points. Secondary end points included investigator-assessed PFS, ORR, duration of response, clinical benefit rate, and safety.

What Data Have Been Previously Reported From ROSELLA?

Previously, data presented at the 2025 ASCO Annual Meeting showed that the addition of relacorilant to nab-paclitaxel extended median PFS by BICR compared with nab-paclitaxel alone across the entire population of patients with PROC (HR, 0.70; 95% CI, 0.54-0.91; log-rank P = .0076).^1,2 Furthermore, data from the interim OS analysis showed that the addition of relacorilant generated a clinically meaningful median OS improvement across the full analysis set, at 16.0 months vs 11.5 months (HR, 0.69; 95% CI, 0.52-0.92; nominal log-rank P = .0121).

What Additional Efficacy Data Were Seen in the Analysis of Prior PARP Inhibitor–Exposed Patients in ROSELLA?

The addition of relacorilant to nab-paclitaxel also showed a trend toward improved OS among patients who had received a prior PARP inhibitor, although these data were only at 50% maturity at the time of this interim analysis.¹ The median OS was 15.61 months (95% CI, 12.02-not reached) with relacorilant plus nab-paclitaxel vs 12.58 months (95% CI, 10.09-15.18) with nab-paclitaxel alone (HR, 0.77; 95% CI, 0.53-1.13; nominal P = .1834).

What Was the Safety Profile of Relacorilant Plus Nab-Paclitaxel in Patients in ROSELLA Who Had Received Prior PARP Inhibition?

Lorusso noted that relacorilant plus nab-paclitaxel continued to be well tolerated in the prior PARP inhibitor subgroup. Any treatment-emergent adverse effects (TEAEs) were observed in all patients in this subgroup. Among safety-evaluable patients with prior PARP inhibitor exposure who received relacorilant plus nab-paclitaxel, grade 3 or higher TEAEs were seen in 71.1%, and serious AEs were reported in 31.6%. TEAE-related dose reductions of relacorilant (7.0%), dose reductions of nab-paclitaxel (46.5%), treatment interruptions (72.8%), and treatment discontinuations (8.8%) were also observed.

Among safety-evaluable patients with prior PARP inhibitor exposure who received nab-paclitaxel alone (n = 117), grade 3 or higher TEAEs were seen in 64.1%, and serious AEs were reported in 21.4%. TEAE-related dose reductions of nab-paclitaxel (29.1%), treatment interruptions (58.1%), and treatment discontinuations (6.8%) were also observed.

“The safety profile in the trial subgroup was very similar to that [seen in] the overall population,” Lorusso concluded.

Disclosures: Lorusso reported receiving grants from or having contracts with AstraZeneca, Clovis, Genmab, GSK, Immunogen, Incyte, MSD, Novartis, PharmaMar, Seagen, and Roche; receiving consulting fees from AstraZeneca, Clovis Oncology, Genmab, GSK, Immunogen, MSD, PharmaMar, Seagen, and Novartis; receiving payment or honoraria from AstraZeneca, Clovis, Corcept, Genmab, GSK, Immunogen, MSD, Oncoinvest, PharmaMar, Seagen, and Sutro; receiving support for attending meetings and/or travel from GSK, AstraZeneca, Clovis, and MSD; and participating on Data Safety Monitoring or Advisory Boards for AstraZeneca, Clovis, Corcept, Genmab, GSK, Immunogen, MSD, Oncoinvest, PharmaMar, Seagen, and Sutro.

References

1. Lorusso D, Quesada S, Chan JK, et al. ROSELLA (GOG3073, ENGOTov72, APGOT-OV10): relacorilant + nab-paclitaxel in the subgroup of patients with platinum-resistant ovarian cancer (PROC) previously exposed to a PARP inhibitor. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA45.
2. Olawaiye A, Gladieff L, Gilbert L, et al. ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). J Clin Oncol. 2025;43(suppl 17):LBA5507. doi:10.1200/JCO.2025.43.17_suppl.LBA5507