ROSELLA/GOG-3073/ENGOT-ov72: trial | Bending the Curve: Trial by Trial

ROSELLA/GOG-3073/ENGOT-ov72

Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial

Phase 3N = 381NCT05257408

Population

Platinum-resistant epithelial ovarian, primary peritoneal or fallopian-tube cancer, one to three previous lines of therapy; all had received bevacizumab; 61% had received a PARP inhibitor (2026 report)

Design

Randomised, open-label phase 3 trial at 117 sites in 14 countries. Patients with platinum-resistant epithelial (high-grade serous, endometrioid or carcinosarcoma with at least 30% epithelial component) ovarian, primary peritoneal or fallopian-tube cancer, up to three previous lines including bevacizumab, were randomised 1:1 to relacorilant 150 mg orally the day before, of and after nab-paclitaxel 80 mg/m2 on days 1, 8 and 15 of a 28-day cycle, or nab-paclitaxel monotherapy 100 mg/m2 on the same schedule. Dual primary end points: PFS by blinded independent central review and OS.

Primary endpoint

PFS, OS

Arms

Relacorilant plus nab-paclitaxel (experimental, n = 188): Relacorilant 150 mg orally the day before, day of and day after nab-paclitaxel 80 mg/m2 intravenously on days 1, 8, 15 of a 28-day cycle
Nab-paclitaxel (control, n = 193): Nab-paclitaxel 100 mg/m2 intravenously on days 1, 8, 15 of a 28-day cycle

People

Olawaiye AB

PFSHR 0.70 (95% CI 0.54–0.91)Δ median PFS+1.02 monthsOSHR 0.69 (95% CI 0.52–0.92)Δ median OS+4.47 monthsOSHR 0.65 (95% CI 0.51–0.83)Δ median OS+4.1 months

Show the numbers

Results reported for ROSELLA/GOG-3073/ENGOT-ov72
Endpoint	Analysis	Relacorilant plus nab-paclitaxel	Nab-paclitaxel	Effect
PFS	primaryOlawaiye 2025	median 6.54 months (5.55–7.43)	median 5.52 months (3.94–5.88)	HR 0.70 (95% CI 0.54–0.91)P=0.0076Blinded independent central review; stratified log-rank p.
OS	interimOlawaiye 2025	median 15.97 months	median 11.5 months (10.02–13.57)	HR 0.69 (95% CI 0.52–0.92)P=0.0121Planned interim analysis. The 95% CI for the relacorilant median is 13.47 to not reached.
OS	finalmedian follow-up 24.8 monthsLorusso 2026	median 16 months (13.0–18.3)	median 11.9 months (10.0–13.8)	HR 0.65 (95% CI 0.51–0.83)P=0.0004Final OS analysis. The median OS in the combination group was 4.1 months longer.

Results reported for ROSELLA/GOG-3073/ENGOT-ov72
Endpoint	Analysis	Relacorilant plus nab-paclitaxel	Nab-paclitaxel	Effect
PFS	primaryOlawaiye 2025	median 6.54 months (5.55–7.43)	median 5.52 months (3.94–5.88)	HR 0.70 (95% CI 0.54–0.91)P=0.0076Blinded independent central review; stratified log-rank p.
OS	interimOlawaiye 2025	median 15.97 months	median 11.5 months (10.02–13.57)	HR 0.69 (95% CI 0.52–0.92)P=0.0121Planned interim analysis. The 95% CI for the relacorilant median is 13.47 to not reached.
OS	finalmedian follow-up 24.8 monthsLorusso 2026	median 16 months (13.0–18.3)	median 11.9 months (10.0–13.8)	HR 0.65 (95% CI 0.51–0.83)P=0.0004Final OS analysis. The median OS in the combination group was 4.1 months longer.

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
PFS	0.7	0.54–0.91
OS	0.69	0.52–0.92
OS	0.65	0.51–0.83

Illustrative — modelled from reported values, not trial data. PFS, primary.

Show curves

Relacorilant plus nab-paclitaxel (experimental)
Nab-paclitaxel (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Relacorilant plus nab-paclitaxel	Nab-paclitaxel
0	100.0%	100.0%
4	65.4%	60.5%
8	42.8%	36.6%
12	28.0%	22.2%
16	18.3%	13.4%

Illustrative — modelled from reported values, not trial data. OS, interim.

Show curves

Relacorilant plus nab-paclitaxel (experimental)
Nab-paclitaxel (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Relacorilant plus nab-paclitaxel	Nab-paclitaxel
0	100.0%	100.0%
10	64.8%	54.7%
20	42.0%	30.0%
30	27.2%	16.4%
40	17.6%	9.0%

Appears in

2025 Relacorilant plus nab-paclitaxel, platinum-resistant: ROSELLA

Sources

Olawaiye AB, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Salutari V, et al. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. Lancet. 2025;405(10496):2205-2216.
PubMed DOI
Lorusso D, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Fagotti A, et al. Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial. Lancet. 2026;407(10538):1513-1524.
PubMed DOI