Editor’s Note: In recent years, novel therapies targeting folate receptor alpha (FRα)—such as mirvetuximab soravtansine-gynx—have offered new hope for patients with FRα-high, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. However, for patients without this biomarker, treatment options remain limited.Now, results from the global, randomized, open-label, Phase III ROSELLA trial have drawn significant attention. The study evaluated relacorilant, a selective glucocorticoid receptor (GR) antagonist, in combination with nab-paclitaxel in patients with recurrent, platinum-resistant high-grade serous epithelial ovarian cancer who had received 1–3 prior lines of systemic therapy (including bevacizumab). Compared with nab-paclitaxel alone, the combination therapy significantly improved progression-free survival (PFS), with median PFS assessed by blinded independent central review (BICR) at 6.5 months vs. 5.5 months (hazard ratio [HR] = 0.70; P = 0.008).
Interim overall survival (OS) results also showed clinically meaningful improvement (HR = 0.69), with median OS of 16.0 months versus 11.5 months (P = 0.01). Adverse events (AEs) were similar between the two treatment arms, and the relacorilant + nab-paclitaxel regimen was well tolerated with no new safety signals observed. The most common AEs were consistent with known toxicities of nab-paclitaxel: anemia (58%), neutropenia (56%), and nausea (39%).
At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Dr. Alexander Olawaiye of the Gynecologic Oncology Group at Magee-Womens Hospital, University of Pittsburgh School of Medicine, will deliver a detailed oral presentation of the ROSELLA study (Abstract LBA5507). Ahead of the session, Oncology Frontier spoke with Dr. Olawaiye on-site to discuss the findings and their clinical significance.
Oncology Frontier: Based on the latest results from the ROSELLA study (LBA5507), how would you evaluate the efficacy and safety of relacorilant in combination with nab-paclitaxel for patients with platinum-resistant ovarian cancer?
Dr. Olawaiye: This trial had a dual primary endpoint. One, progression-free survival. Two, overall survival. What dual primary endpoints meant is if either endpoint was positive, the trial would be positive. So, the progression-free survival endpoint has already read out, and that is what we presented, there is a highly statistically significant difference in progression free survival between the two arms of the trial. The hazard ratio for progression free survival is 0.7 in favor of the relacorilant arm. This represents a 30% reduction in the hazard of progression of disease or death. The overall survival data is not yet mature, but we have already begun to see the curves separate. The hazard ratio for overall survival is 0.69, which again, is a 31% reduction in the hazard of death. These findings are very compelling, and they are very exciting.
Oncology Frontier: Given the challenges associated with timely FRα biomarker testing in tissue samples, the relacorilant-based regimen does not require biomarker selection. Do you think this feature offers particular advantages in resource-limited settings?
Dr. Olawaiye: Yes. Again, that is what is exciting about it. For biomarker selection, that is a good thing. The folate receptor-alpha (FRα) targeting drug is very good, however, only a percentage of patients’ cancer express high levels of FRα, so the uniqueness of this new medication, relacorilant, is that there is no necessity for biomarker selection. If the patient has platinum-resistant ovarian cancer, they are eligible to be treated with relacorilant combined with nab-paclitaxel when that combination is available. As you know, it is not yet FDA-approved, but we are hopeful.
Oncology Frontier: As a glucocorticoid receptor antagonist, does relacorilant therapy have any impact on the development of new-onset diabetes or hypertension?
Dr. Olawaiye: Glucocorticoid signaling is actually pro-diabetic, which means if somebody has too much glucocorticoid exposure, it disturbs the ability to metabolize sugar properly. For instance, if you give diabetic patients glucocorticoids, their diabetes becomes very difficult to control. Relacorilant functions in the opposite way. It blocks glucocorticoid signaling. Even though we did not study this as a treatment for diabetes, the biology of it is that diabetes or difficulty with diabetes control would not be a problem as a side effect of relacorilant. It may even help diabetes control.
Oncology Frontier: At ASCO 2025, a large number of studies on gynecologic cancers were presented. In your opinion, which of these studies are likely to have the most significant impact on clinical practice?
Dr. Olawaiye: ROSELLA is one of those studies that I think is going to be clinically impactful, because, remember that relacorilant is a first-in-class drug in ovarian cancer. We have never seen anything like it before. The other trials were that were presented, studied drugs that are already in use, either in ovarian cancer and now modified with another agent, or are already established in other cancers. This study and its previous two forerunners represent the first time relacorilant would be studied in any cancer. We are so excited about the findings, and we are hoping this is going to be a new standard in platinum-resistant ovarian cancer treatment.
Reference: 1.Olawaiye A, et al. ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). 2025 ASCO, LBA5507.
