Dr Olawaiye on the Final OS Data From the Phase 3 ROSELLA Trial in Platinum-Resistant Ovarian Cancer

“What I presented [at the 2026 SGO Annual Meeting] is the mature final overall survival data, which is highly statistically significantly positive with a hazard ratio of 0.65.”

Alexander Olawaiye, MD, vice chair for DEI and professor in the Department of Obstetrics, Gynecology and Reproductive Sciences, and director of gynecologic cancer research at Magee-Women’s Hospital at the University of Pittsburgh Medical Center, discussed the final overall survival (OS) results from the phase 3 ROSELLA trial (NCT03776812) evaluating relacorilant (Lifyorli) in combination with nab-paclitaxel (Abraxane) vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (PROC).

Enthusiasm for the regimen initially stemmed from previously reported progression-free survival (PFS) data, which demonstrated a HR of 0.70, corresponding to a 30% reduction in the risk of disease progression or death vs chemotherapy alone, Olawaiye explained. At that earlier analysis, OS data were immature but already suggested a favorable trend, with an HR of 0.69, indicating a 31% reduction in the risk of death.

With longer follow-up, the now-mature OS results confirm and exceed those early signals, Olawaiye said. The final analysis shows a statistically significant and clinically meaningful improvement in survival, with an HR of 0.65 (95% CI, 0.51-0.83; 2-sided stratified log-rank P = .0004), translating to a 35% reduction in the risk of death compared with chemotherapy alone. These findings surpassed initial expectations and reinforce the robustness of the treatment effect with relacorilant.

OS remains the gold standard end point in clinical trials, particularly in the platinum-resistant setting, where therapeutic advances have historically been limited and outcomes remain poor. The magnitude of benefit observed with relacorilant plus nab-paclitaxel is therefore notable and represents a meaningful step forward for this patient population. Overall, the ROSELLA trial provides compelling evidence supporting the addition of relacorilant to nab-paclitaxel as a new standard of care in platinum-resistant ovarian cancer following its FDA approval in March 2026.