Relacorilant Plus Nab-Paclitaxel Improves Outcomes in Platinum-Resistant Ovarian Cancer: Brian Slomovitz, MD

Relacorilant combined with nab-paclitaxel (Abraxane) 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) shared Monday in a late-breaking oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

In part 1 of an interview with The American Journal of Managed Care^®, Brian Slomovitz, MD, one of the trial's investigators, provides background on the new data, describing relacorilant's mechanism of action and findings from the phase 2 ROSELLA trial (NCT03776812). He also outlines 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 serves as the clinical trial lead for uterine cancer for GOG Partners.

This transcript was lightly edited; captions were auto-generated.

Transcript

To start, could you describe the mechanism of action of relacorilant?

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 side 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 the glucocorticoid receptor, and most of these are found on the tumor, not throughout the rest of the body. By inhibiting those, it helps to prohibit cellular growth and proliferation.

Building on that, can you summarize the phase 2 ROSELLA trial results?

What we did in the phase 2 trial was look for activity. We were not surprised but very pleased that, in that setting, we found an improvement in progression-free survival and even a trend towards overall survival in those patients who are treated with relacorilant, which really stimulated us and encouraged us to proceed with a regulatory approval-designed phase 3 trial, which we're excited about being presented here at the ASCO meeting.

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

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 the 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.

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

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's 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 cancers, 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.