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Relacorilant Plus Nab-Paclitaxel Significantly Extends Overall Survival in Platinum-Resistant Ovarian Cancer
Adding relacorilant to nab-paclitaxel reduced the risk of death by approximately 35% compared with nab-paclitaxel alone in patients with platinum-resistant ovarian cancer, extending median overall survival by 4.1 months (HR 0.65, 95% CI 0.51–0.83; p=0.0004). The effect was achieved without requiring biomarker-based patient selection, suggesting broad applicability across this difficult-to-treat population.
What Was Studied
This trial investigated whether adding relacorilant — a selective glucocorticoid receptor antagonist designed to restore or enhance chemotherapy sensitivity — to standard nab-paclitaxel chemotherapy could improve overall survival in patients with platinum-resistant ovarian cancer. The primary endpoint was overall survival, with the trial building on an earlier finding of significant progression-free survival benefit from the same regimen.
How It Was Studied
ROSELLA was an international, open-label, phase 3 randomised controlled trial enrolling 381 patients with platinum-resistant ovarian cancer, all of whom had previously received bevacizumab. Patients were allocated 1:1 to receive either relacorilant (150 mg orally on the day before, the day of, and the day after each nab-paclitaxel infusion) combined with nab-paclitaxel (80 mg/m²), or nab-paclitaxel monotherapy alone. The study population was heavily pretreated: 44% had received three prior lines of therapy, and 61% had previously received a PARP inhibitor. Final overall survival results were reported at a median follow-up of 24.8 months (95% CI 23.6–25.7).
What Was Observed
- Overall survival was meaningfully and statistically significantly improved with the relacorilant combination: median OS was 16.0 months (95% CI 13.0–18.3) versus 11.9 months (95% CI 10.0–13.8) with monotherapy, a difference of 4.1 months. This represents approximately 35% lower risk of death in the combination arm (HR 0.65, 95% CI 0.51–0.83; p=0.0004).
- The 18-month overall survival rate was substantially higher in the relacorilant group: 46% of patients in the combination arm were alive at 18 months compared with 27% in the monotherapy arm — a difference of 19 percentage points, suggesting a durable survival benefit that extended well beyond the median.
- Adverse events were comparable between groups when adjusted for the longer duration of treatment exposure in the combination arm. The most frequently reported adverse events in the relacorilant group were neutropenia (64%), anaemia (61%), fatigue (54%), and nausea (44%), consistent with the known toxicity profile of nab-paclitaxel. No new safety signals emerged with extended follow-up.
- Subsequent anticancer treatment use was similar across both arms, indicating that the survival advantage observed in the combination group was not attributable to differential access to post-study therapies.
Why This Matters
Platinum-resistant ovarian cancer represents a stage of disease where effective treatment options are limited and outcomes are poor. This trial demonstrates that pharmacological antagonism of the glucocorticoid receptor can translate into a clinically meaningful overall survival gain in this setting, without the need to pre-select patients based on a biomarker — a practical advantage that could simplify treatment eligibility. The authors conclude that relacorilant plus nab-paclitaxel has the potential to become a new standard-of-care option for this patient population.
How to Read This Result
This is a large, randomised phase 3 trial with a robust effect size and narrow confidence intervals, supporting high confidence in the direction of the finding; however, the open-label design introduces the possibility of performance or assessment bias, and this should be considered when interpreting outcome data.
Limitations
The abstract does not explicitly report study limitations.