Clinical Summary: 

• Design/Context: The phase 3 ROSELLA trial compared relacorilant plus nab-paclitaxel versus nab-paclitaxel alone in patients with platinum-resistant ovarian cancer.
• Key Outcomes: The addition of relacorilant significantly improved overall survival and previously demonstrated progression-free survival benefit, with durable outcomes and minimal added toxicity.
• Clinical Relevance: This combination represents a new standard option for patients with platinum-resistant ovarian cancer, providing meaningful survival benefit without requiring biomarker selection.

Alexander Olawaiye, MD, University of Pittsburgh, Pittsburgh, Pennsylvania, discusses final overall survival (OS) results from the phase 3 ROSELLA trial evaluating relacorilant plus nab-paclitaxel among patients with platinum-resistant ovarian cancer.

Results demonstrated that this combination significantly improved survival compared with nab-paclitaxel alone, supporting its role as a new treatment option without the need for biomarker selection.

Dr Olawaiye presented these results at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in San Juan, Puerto Rico. 

Transcript: 

My name is Alexander Olawaiye, I’m a professor of obstetrics and gynecology and reproductive sciences at the University of Pittsburgh School of Medicine and also a professor of gynecologic oncology. I presented the final overall survival data from the ROSELLA trial at the recently concluded Society of Gynecologic Oncology (SGO) meeting in San Juan, Puerto Rico.

ROSELLA is a randomized phase 3 trial of relacorilant in combination with nab-paclitaxel weekly infusion versus nab-paclitaxel weekly infusion alone. The study had dual primary end points of progression-free survival, by blinded independent central review [BICR], and overall survival. The progression-free survival data were previously presented and were positive. The final overall survival data matured in March and this was the main data presented at the SGO meeting.

The results were positive, with a statistically significant, 35% reduction, in the risk of death in favor of the relacorilant arm. Patients who received relacorilant on the trial appeared to have a sustained benefit for a long period of time. By the time we were 18 months into the trial, half of the patients on the relacorilant arm were still alive compared to just 27% on the control arm. 

Another very important finding in this trial was how well tolerated the relacorilant regimen was. There were very minimal impactful side effects, and most of the side effects that we saw were those already well established with nab-paclitaxel– we did not see anything that we could ascribe to relacorilant. The side effects appeared slightly worse in the relacorilant arm, likely because those patients were doing better and therefore remained on nab-paclitaxel for a longer duration. We also were able to look at the subsequent therapies received after patients after exit of the trial and these were very similar between the 2 arms. The benefits that we saw in the relacorilant trial are therefore due to the intervention given on that trial as opposed to subsequent therapy impact. 

Many thanks to the FDA, this regimen is now available to our patients with platinum-resistant ovarian cancer and there is no need for biomarker selection. We are, of course, very grateful to all of the investigators who helped carry out this important landmark trial.

Source: 

Olawaiye A, Quesada S, Gilbert L, et al. Final overall survival (OS) results from the phase 3 ROSELLA trial: Relacorilant plus nab-paclitaxel vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (PROC) (GOG-3073, ENGOT-ov72, APGOT-Ov10, and LACOG-0223). Presented at SGO Annual Meeting on Women’s Cancer. April 10 - 13, 2026; San Juan, Puerto Rico. LBA1.