Relacorilant/Nab-Paclitaxel Maintains OS Benefit Irrespective of Prior Taxane Use in Platinum-Resistant Ovarian Cancer

Final overall survival (OS) subgroup analyses from the phase 3 ROSELLA trial (NCT05257408) demonstrated a consistent survival benefit with relacorilant (Lifyorli) plus nab-paclitaxel (Abraxane) vs nab-paclitaxel monotherapy, regardless of prior taxane exposure or taxane-free interval, in patients with platinum-resistant ovarian cancer, according to data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.¹

At the final OS analysis, with a data cutoff of January 8, 2026, and a median follow-up of 24.8 months, the patients treated in the combination arm (n = 188) achieved a median OS of 16.0 months (95% CI, 13.0-18.3) vs 11.9 months (95% CI, 10.0-13.8) with monotherapy (n = 193; HR, 0.65; 95% CI, 0.51-0.83; P = .0004), representing a 35% reduction in the risk of death.

ROSELLA also met its co–primary end point of progression-free survival (PFS) at the primary analysis, with a median PFS of 6.5 months (95% CI, 5.6-7.4) vs 5.5 months (95% CI, 3.9-5.9) by blinded independent central review (HR, 0.70; 95% CI, 0.54-0.91; P = .0076). These results supported the March 2026 FDA approval of relacorilant plus nab-paclitaxel for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 systemic treatment regimens, at least 1 of which included bevacizumab (Avastin).²

How was the ROSELLA trial designed?

ROSELLA enrolled patients 18 years and older with epithelial ovarian, primary peritoneal, or fallopian tube cancer with an ECOG performance status of 0 or 1, progression within 6 months of the last dose of platinum therapy, and 1 to 3 prior lines of therapy; there was also a requirement for prior bevacizumab.¹ The trial randomly assigned patients 1:1 to relacorilant at 150 mg plus nab-paclitaxel at 80 mg/m² on days 1, 8, and 15 of each 28-day cycle, or nab-paclitaxel monotherapy at 100 mg/m² on the same schedule. Key stratification factors included prior lines of therapy (1 vs > 1) and region (North America vs Europe vs Korea, Australia, and Latin America).

Secondary end points included investigator-assessed PFS, objective response rate, duration of response, clinical benefit rate, response by CA-125 GCIG criteria, and safety.

Baseline characteristics were well balanced between arms. Approximately 60% of patients in each arm had received a prior PARP inhibitor (60.6% vs 62.2%). Nearly all patients (99.5% in each arm) had received a prior taxane; however, most patients had a taxane-free interval of greater than 6 months (87.8% in the combination arm vs 82.4% with monotherapy), and approximately 19% in each arm had received a taxane as their most recent regimen. Only 4.3% of patients in the experimental arm and 3.6% in the control arm had received prior taxane therapy in the platinum-resistant setting.

What did the prior taxane subgroup analyses reveal?

Forest plot analysis demonstrated that the OS HR favored relacorilant plus nab-paclitaxel across all prespecified subgroups.

Among patients with a taxane-free interval of 6 months or fewer, median OS was 16.7 months (95% CI, 7.9-18.7) for the relacorilant arm (n = 22) vs 11.0 months (95% CI, 7.6-13.3) for the control arm (n = 33; HR, 0.60; 95% CI, 0.31-1.15). In patients with a taxane-free interval greater than 6 months, median OS was 15.7 months (95% CI, 12.4-19.3) for the relacorilant group (n = 165) vs 12.1 months (95% CI, 9.8-14.3) for the nab-paclitaxel group (n = 159; HR, 0.66; 95% CI, 0.51-0.86).

OS was also improved with relacorilant plus nabpaclitaxel for patients who had received a taxane as their most recent prior regimen (HR, 0.67; 95% CI, 0.38-1.19), and among those who had not received a recent taxane (HR, 0.63; 95% CI, 0.48-0.82). Subsequent therapies were well balanced between arms, with similar rates of gemcitabine. An earlier analysis of ROSELLA previously demonstrated a PFS benefit in patients with prior PARP inhibitor exposure.³

What did the safety analysis show?

At the final OS data cutoff, the safety profile of relacorilant plus nab-paclitaxel was consistent with the profile observed at the primary analysis, and no new safety signals were identified. Grade 3 or higher adverse events (AEs) occurred in 74.5% of patients in the combination arm vs 59.5% with monotherapy. Serious AEs were reported in 35.1% vs 23.7%, and AEs leading to relacorilant discontinuation occurred in 10.1% of patients, whereas AEs leading to nab-paclitaxel discontinuation occurred in 9.6% of patients in the experimental arm vs 7.9% of patients in the control arm.

The most common AEs (> 20% in the combination arm) included neutropenia (64% all grades; 44% grade ≥ 3), anemia (61%; 18%, respectively), fatigue (54%; 9%), nausea (44%; 4%), and diarrhea (39%; 4%). When adjusted for duration of exposure, the incidence rates of neutropenia and anemia were similar across study arms. Peripheral neuropathy occurred at similar frequencies in both arms (19.1% vs 17.4%, respectively). There were no relacorilant-related fatal AEs and no cases of adrenal insufficiency.

References

1. Gilbert L, You B, Olawaiye AB, et al. Overall survival subgroup analyses for prior taxane use in the phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer. Presented at: 2026 ASCO Annual Meeting; May 29-June 2, 2026; Chicago, IL. Abstract 5503.
2. FDA approves relacorilant plus nab-paclitaxel for platinum-resistant ovarian cancer. OncLive. March 25, 2026. Accessed May 29, 2026. https://www.onclive.com/view/fda-approves-relacorilant-plus-nab-paclitaxel-for-platinum-resistant-ovarian-cancer
3. Relacorilant plus nab-paclitaxel yields PFS advantage in PARP inhibitor–exposed PROC. OncLive. October 19, 2025. Accessed May 29, 2026. https://www.onclive.com/view/relacorilant-plus-nab-paclitaxel-yields-pfs-advantage-in-parp-inhibitor-exposed-proc