SPOTLIGHT: Relacorilant Plus Nab-Paclitaxel Improves Outcomes in Platinum-Resistant Ovarian Cancer

Relacorilant combined with nab-paclitaxel (Abraxane; Bristol Myers Squibb) significantly improved progression-free survival and prolonged overall survival in patients with platinum-resistant ovarian cancer compared with nab-paclitaxel alone, according to results from the phase 3 ROSELLA trial (NCT05257408) presented during a late-breaking oral presentation at the 2025 American Society of Clinical Oncology Annual Meeting.

Brian Slomovitz, MD | Image: Mt. Sinai

In an interview with The American Journal of Managed Care (AJMC), Brian Slomovitz, MD, one of the trial’s investigators, provided background on the new data, describing relacorilant’s mechanism of action and findings from the phase 2 ROSELLA trial (NCT03776812). He also outlined the objectives and results of the phase 3 trial.

Slomovitz is director of gynecologic oncology and cochair of the clinical research committee at Mount Sinai Medical Center in Miami Beach, Florida. He also is the clinical trial lead for uterine cancer for GOG Partners.

AJMC: Can you summarize the key findings from the phase 3 trial? Were there any that stood out to you?

Slomovitz: The primary end point of the study was progression-free survival, and it really met its primary end point. Adding relacorilant extended the progression-free survival by blinded independent review, so there were no biases; [it’s a] blind, independent radiological review.

It decreased the risk of recurrence by 30%. The medians were 6.5 versus 5.5 months, which was statistically significant. Again, these are in patients with platinum-resistant, heavily pretreated ovarian cancer, so it really highlights the advantage there.

In addition—and this is where we were a little bit pleasantly surprised—there was an overall survival benefit in this interim analysis. The addition of the relacorilant to the nab-paclitaxel had a meaningful improvement in overall survival, with a 31% decreased risk of death in those patients treated with relacorilant.

AJMC: Please describe the mechanism of action of relacorilant.

Slomovitz: One of the nice things about this agent, as we treat people in later lines of therapy...is quality of life and making sure the adverse effect profile is tolerable.

Relacorilant is an oral therapy. It’s what we call a selective glucocorticoid receptor or a GR antagonist. It works by modulating cortisol activity. It binds to glucocorticoid receptors, and most of these are found on the tumor, not throughout the rest of the body. By inhibiting those, relacorilant helps to prohibit cellular growth and proliferation.

AJMC: Building on that, please summarize the phase 2 ROSELLA
trial results.

Slomovitz: What we did in the phase 2 trial was look for activity. We were not surprised, but we were very pleased that, in that setting, we found an improvement in progression-free survival and even a trend toward overall survival in those patients who are treated with relacorilant. That really stimulated us and encouraged us to proceed with a regulatory approval-designed phase 3 trial.

AJMC: Based on these findings, what was the objective of the phase 3 ROSELLA trial?

Slomovitz: We took a pretty traditional approach. We had the activity data that we saw from the phase 2 trial, and we wanted to compare it with the standard of care to see if it could replace the standard of care.

The standard-of-care arm that we chose in this trial was nab-paclitaxel. It’s a very active agent. It’s part of the taxane group, which we know is FDA-approved. The taxanes are FDA-approved for ovarian cancer. That was the control arm.

The treatment arm was adding the relacorilant to the nab-paclitaxel to see which was better. It was a superiority design to see if the experimental arm could beat out the control arm.

This transcript was lightly edited.

Reference
Olawaiye A, Gladieff L, Gilbert L, et al. ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). J Clin Oncol. 2025;43(suppl 17):LBA5507. doi:10.1200/JCO.2025.43.17_suppl.LBA5507