As reported in The Lancet by Lorusso et al, the phase III ROSELLA trial has shown an improvement in overall survival with the addition of relacorilant to nab-paclitaxel in patients with platinum-resistant ovarian cancer. Relacorilant is a selective glucocorticoid receptor antagonist that acts to increase sensitivity of many cancer cell types to chemotherapy.
The primary analysis of the trial showed a significant progression-free survival benefit with the addition of relacorilant to nab-paclitaxel (hazard ratio [HR] = 0.70, P = .0076).
Study Details
In the international open-label trail, 381 patients who had received one to three prior lines of therapy and had platinum-resistant disease (progression < 6 months from last dose of platinum) were randomly assigned between January 2023 and April 2024 to receive relacorilant at 150 mg orally the day before, day of, and day after nab-paclitaxel infusion plus nab-paclitaxel at 80 mg/m² on days 1, 8, and 15 of each 28-day cycle (n = 188) or nab-paclitaxel monotherapy at 100 mg/m² on the same schedule. All patients had received bevacizumab, 44% had received three previous lines of therapy, and 61% had received a PARP inhibitor. The dual primary endpoints were progression-free survival, assessed by blinded independent central review, and, reported here, overall survival.
Key Findings
Subsequent systemic anticancer treatment was received by 68% of the relacorilant combination group and 72% of the control group.
At a median follow-up of 24.8 months (95% confidence interval [CI] = 23.6–25.7 months), the relacorilant combination group had significantly better overall survival vs the control group (hazard ratio [HR] = 0.65, 95% CI = 0.51–0.83, P = .0004); overall survival at 18 months was 46% vs 27%, and median overall survival was 16.0 months (95% CI = 13.0–18.3 months) vs 11.9 months (95% CI = 10.0–13.8 months).
Adverse events of grade 3 or higher were reported in 75% of the relacorilant combination group vs 59% of the control group; the most common in both groups were neutropenia (44% vs 25%) and anemia (18% vs 9%). Serious adverse events occurred in 35% vs 24% of patients. One death considered related to treatment (nab-paclitaxel) was reported in the combination group (due to septic shock). No new safety signals were observed during follow-up since the primary analysis.
The investigators concluded: “The addition of relacorilant to nab-paclitaxel led to significantly longer overall survival in patients with platinum-resistant ovarian cancer, without the need for biomarker selection. The findings support relacorilant plus nab-paclitaxel as a potential new standard treatment option for patients with platinum-resistant ovarian cancer.”
Domenica Lorusso, MD, of Humanitas San Pio X Hospital, Milan, Italy, is the corresponding author for The Lancet article.
DISCLOSURE: The study was funded by Corcept Therapeutics. For full disclosures of the study authors, visit thelancet.com.
