Relacorilant Plus Nab-Paclitaxel for Patients With Platinum-Resistant Ovarian Cancer

Clinical Summary:

• Design/Population: In the phase 3 ROSELLA trial, 400 patients with platinum-resistant ovarian cancer received either relacorilant plus nab-paclitaxel or nab-paclitaxel alone.
• Key Outcomes: The combination significantly improved progression-free survival and overall survival, supporting regulatory approval.
• Clinical Relevance: Relacorilant plus nab-paclitaxel represents a new chemotherapy-based option, addressing a major unmet need and expanding the treatment landscape with a well-tolerated, orally administered targeted combination strategy.

Brian Slomovitz, MD, Mount Sinai Medical Center, Miami, Florida, discusses results from the phase 3 ROSELA trial which compared relacorilant plus nab-paclitaxel and nab-paclitaxel alone in patients with platinum-resistant ovarian cancer. 

Based on these results from this open-label study, the FDA approved relacorilant plus nab-paclitaxel, establishing a new treatment option with demonstrated survival benefit for patients with platinum-resistant ovarian cancer.

Transcript:

Hi, my name is Dr Brian Slomovitz. I'm the director of gynecologic oncology here at Mount Sinai Medical Center in Miami Beach, Florida. I also serve as the co-chair of the cancer research committee here. I'll be talking about the ROSELA trial and it's FDA approval. We just received FDA approval on March 25th, so I'm excited about this. 

Let me go through the data a little bit to show you what impact it may have on our patients.

The ROSELA trial studied the drug called relacorilant, which is a glucocorticoid receptor antagonist, in combination with a drug called nab-paclitaxel for those patients with platinum-resistant ovarian cancer. Platinum-resistant, meaning they're no longer platinum-sensitive and they're not as responsive to chemotherapeutic or targeted therapies, and we need to come up with better treatment options– this is a tremendous unmet need.

Previously, we have shown and demonstrated, and published, in Lancet that the progression-free survival was significantly improved in those patients treated with relacorilant and nab-paclitaxel compared to the standard-of-care chemotherapies. Most recently, it was announced that there's an improvement with overall survival as well, which was statistically significant. 

Those 2 findings, the progression-free survival and the overall survival led to this FDA approval. I'll dive into the data in a second, but I really just want to highlight that relacorilant plus nab-paclitaxel really represents a new chemotherapy-based combination with a survival benefit in these patients– again, this is a tremendous unmet need.

In order to get the approval, what we did is the ROSELA trial, which is a multi-centered, open-label, randomized trial. We enrolled almost 400 patients and patients were randomized 1:1 between nab-paclitaxel and relacorilant versus nab-paclitaxel alone. The primary efficacy end points were progression-free survival and overall survival.

The median progression-free survival was 6.5 months compared to 5.5 months in the control arm, but the hazard ratio was 0.7, representing a 30% decreased risk of recurrence or deaths in those patients treated with the experimental arm. The confidence interval there did not cross 1, making it statistically significant. 

Regarding overall survival, the median overall survival was 16 months compared to 11.9 months. This in fact represented a 35% decreased risk of death in those patients treated with relacorilant. 

[This is]really something that is game-changing for what we do in the field of platinum-resistant ovarian cancer and coming up with better options. 

As far as dosing, it's relatively easy to give. The relacorilant is 150 milligrams orally once daily on the day before, the day of, and the day after the nab-paclitaxel infusion. We continued therapy until disease progression or unacceptable toxicity.

Overall, and a little bit of my opinion on this, I think it's a game-changer. We need to come up again with better treatment options. I in fact enrolled patients on this trial, I'm a coauthor of the study [and] I would say that the patients that I enrolled did very, very well and it was very tolerable. I'm just happy at this point that we have another treatment option. It's clinically significant for survival and progression-free survival, and it adds another weapon in the armamentarium that we have to fight this deadly disease ovarian cancer. 

Source:

US Food and Drug Administration. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Accessed March 25, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or