Relacorilant plus nab-paclitaxel prolongs survival in platinum-resistant ovarian cancer

The addition of relacorilant to nab-paclitaxel provides survival benefits in patients with platinum-resistant ovarian cancer (PROC) compared with weekly taxane, according to the results of the phase III ROSELLA study, presented at ESMO Gyn 2025.

This finding sets the relacorilant plus nab-paclitaxel regimen as a “new standard for patients with PROC, without the need for biomarker selection,” said lead author Dr Domenica Lorusso, Department of Biomedical Sciences, Humanitas University, Humanitas San Pio X Hospital, Milan, Italy.

Lorusso and colleagues conducted this randomized, controlled, open-label, global study to compare relacorilant plus nab-paclitaxel with nab-paclitaxel alone in patients with PROC. Participants were eligible if they had received one to three previous lines of anticancer therapy and prior bevacizumab.

A total of 381 women met the eligibility criteria. Between 5 January 2023 and 8 April 2024, participants were randomly allocated to receive either relacorilant 150 mg the day before, of, and after nab-paclitaxel plus nab-paclitaxel 80 mg/m² on days 1, 8, and 15 of each 26-day cycle (n=188) or nab-paclitaxel alone 100 mg/m² on the same schedule (n=193).

The primary endpoints were progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS). Other endpoints assessed were as follows: PFS by investigator, objective response rate, best overall response, duration of response, and safety. [ESMO Gyn 2025, abstract 70O]

Baseline characteristics of eligible participants were well balanced. Both primary endpoints were met. Treatment with relacorilant plus nab-paclitaxel led to significant improvements in PFS by BICR compared with nab-paclitaxel monotherapy (hazard ratio [HR], 0.70, 95 percent confidence interval [CI], 0.54‒0.91; median 6.5 vs 6.6 months; p=0.008). PFS by investigator was also consistent (HR, 0.71; p=0.003).

At the planned interim analysis, Lorusso and her team observed a clinically significant improvement in OS with the addition of relacorilant to nab-paclitaxel (HR, 0.69, 95 percent CI, 0.52‒0.92; median 16.0 vs 11.5 months; p=0.01).

Safety profile

Adverse events (AEs) reported did not significantly differ between treatment arms. Relacorilant plus nab-paclitaxel was well tolerated and showed no new safety signals. Anaemia (58 percent) was the most frequent AE reported, followed by neutropenia (56 percent) and nausea (39 percent).

Overall, combined treatment with relacorilant and nab-paclitaxel led to a prolonged PFS, while interim results showed an improvement in OS. These findings “position the combination of relacorilant and nab-paclitaxel as a potential new standard treatment for patients with PROC,” the researchers said. [Lancet 2025;405:2205-2216]

“Relacorilant is an investigational, selective glucocorticoid receptor antagonist that increases tumour sensitivity to chemotherapy-induced apoptosis,” Lorusso said.

“In a phase II study in patients with PROC, relacorilant plus nab-paclitaxel improved PFS with a trend toward improved OS and a comparable safety profile to nab-paclitaxel alone,” she added.

ROSELLA was conducted in 117 hospitals and community oncology treatment centres in 14 countries across Australia, Europe, Latin America, North America, and South Korea.