Relacorilant Plus Nab-Paclitaxel Provides PFS Benefit in Platinum-Resistant Ovarian Cancer

Alexander B. Olawaiye, MD

Promising initial efficacy and safety data from the phase 3 ROSELLA trial (GOG-3073/ENGOT ov72/APGOT-Ov10/LACOG-0223/ANZGOG-2221/2023; NCT05257408) confirm the benefit of adding relacorilant to nab-paclitaxel (Abraxane) for the management of platinum-resistant ovarian cancer (PROC), according to Alexander B. Olawaiye, MD. 

Data presented at the 2025 ASCO Annual Meeting showed that the median progression-free survival (PFS) via blinded independent central review was 6.54 months (95% CI, 5.55-7.43) with relacorilant plus nab-paclitaxel (n = 188) vs 5.52 months (95% CI, 3.94-5.88) with nab-paclitaxel alone (n = 193; HR, 0.70; 95% CI, 0.54-0.91; P = .0076).1 Furthermore, interim overall survival (OS) data demonstrated a median OS of 15.97 months (95% CI, 13.47-not reached) in the relacorilant arm vs 11.50 months (95% CI, 10.02-13.57) with nab-paclitaxel alone (HR, 0.69; 95% CI, 0.52-0.92; P = .0121).

“Relacorilant is a unique medication,” Olawaiye said in an interview with OncLive®. “It is a first-in-class medication that has never been studied before in cancer. Also unique about it is its mechanism of action because it blocks glucocorticoid signaling.”

In the interview, Olawaiye elaborated on the unique mechanism of action of relacorilant, key efficacy and safety findings from ROSELLA, and where the future is headed for studying this novel agent in patients with ovarian cancer.

Olawaiye is a professor and vice chair for DEI in the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Pittsburgh, and the director of gynecologic cancer research at Magee-Womens Hospital of the University of Pittsburgh Medical Center in Pennsylvania.

OncLive: What was the rationale for the ROSELLA trial?

Olawaiye: ROSELLA is a study of relacorilant. This pill is a selective glucocorticoid receptor antagonist that we have studied in 2 previous trials, phase 1 [NCT02762981] and phase 2 [NCT03776812], before ROSELLA. In the phase 2 study, we demonstrated that this medication, when it’s combined with nab-paclitaxel, extended PFS in patients with PROC. In the randomized phase 3 ROSELLA trial, we took that efficacy to confirmation. We studied relacorilant combined with nab-paclitaxel in the experimental arm and compared that with nab-paclitaxel single-agent therapy in the control arm.

How was ROSELLA designed?

In this ROSELLA study, we enrolled patients who had progressed after 1 month but before 6 months after their last platinum therapy. That’s important because some of those patients—the ones who had progression of disease before 3 months—would have been classified as platinum refractory in other studies. In the relacorilant arm, patients [received the relacorilant] pill the day before, the day of, and the day after the weekly nab-paclitaxel infusion. It was a heavily pretreated patient population. [Most patients] had received 2 or 3 previous lines of chemotherapy before they came to participate in the trial, and approximately 70% of the patients also had prior exposure to PARP inhibitor therapy. All these factors made the patients a high-risk group of patients.

What key efficacy findings were seen in this trial?

The study has 2 primary end points. One is PFS, and [the second is] is OS. The PFS end point was met. The study showed a PFS hazard ratio of 0.70, which is a 30% reduction in the risk of progression or death and was highly statistically significant. The Kaplan-Meier curves that resulted from PFS began to separate as of the first scan, and by approximately 12 months into the study, approximately double the number of patients on the relacorilant arm were without progression compared with those on the nab-paclitaxel alone arm.

What safety data are important to note?

The safety data were also good. The relacorilant combination with nab-paclitaxel was well tolerated. Most of the adverse effects [AEs] that were seen on the trial were AEs that are known to be associated with nab-paclitaxel. The number of AEs that led to discontinuation of therapy was infrequent and balanced between the 2 arms of the study. [Relacorilant plus nab-paclitaxel] was a well-tolerated regimen.

What are the potential clinical implications of the ROSELLA findings?

We’re excited because first of all, the use of relacorilant combined with nab-paclitaxel does not require biomarker selection, which means there is no special testing that needs to be done for a patient to be eligible to benefit from this combination when it becomes available. Simply, the patients who are eligible are those who have been treated for ovarian cancer and who have PROC. [Relacorilant is] also dose convenient because it’s a pill. Patients can use the pill in the comfort of their own homes and only come into the hospital for the infusion. We are also excited because even though the OS data have not matured, the [OS] curves have nicely separated, showing a clinically meaningful extension of OS in the relacorilant arm. At the time of data cutoff in the relacorilant arm, 60% of the patients were alive compared with 49% of those in the control arm.

What are the next steps for investigating relacorilant in patients with ovarian cancer?

It’s a large dataset. We’re going to continue to look at the data as they mature. We are going to conduct subgroup analyses. We’re going to investigate which groups benefited the most and compare [outcomes] across the groups in the study. We’re excited about the secondary studies that we’re going to be doing with these data.

We’re also already planning the next step in studying this exciting drug. We have launched the BELLA trial [NCT06906341], which is a phase 2 trial combining relacorilant with nab-paclitaxel and bevacizumab [(Avastin) in patients with advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer].2 That is going to be an exciting trial to see the results of.

References

1. 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
2. Relacorilant in combination with nab-paclitaxel and bevacizumab in advanced, epithelial ovarian, primary peritoneal, or fallopian-tube cancer. ClinicalTrials.gov. Updated June 24, 2025. Accessed July 11, 2025. https://clinicaltrials.gov/study/NCT06906341?term=bella&rank=5