Dr Olawaiye on Relacorilant Plus Nab-Paclitaxel in Platinum-Resistant Ovarian Cancer

“We are excited because the use of relacorilant plus nab-paclitaxel does not require biomarker selection; 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, eligible patients are those who have been treated for ovarian cancer and have [platinum-resistant disease].”

Alexander B. Olawaiye, MD, a professor in the Department of Obstetrics & Reproductive Sciences at the University of Pittsburgh, and the director of gynecologic cancer research at Magee-Women’s Hospital of the University of Pittsburgh Medical Center, discussed the clinical implications of data from the phase 3 ROSELLA trial (NCT05257408).

ROSELLA examined the novel, selective glucocorticoid receptor antagonist relacorilant in combination with nab-paclitaxel (Abraxane) in patients with platinum-resistant ovarian cancer. Patients were required to have an ECOG performance status of 0 or 1, have received 1 to 3 prior lines of therapy, including bevacizumab (Avastin), and have evidence of disease progression less than 6 months after the final dose of platinum-based chemotherapy.

The dual primary end points were progression-free survival per RECIST 1.1 criteria by blinded independent central review and overall survival (OS). Secondary end points included investigator-assessed PFS, overall response rate, duration of response, and safety, among others.

Data from an interim analysis of ROSELLA presented during the 2025 ASCO Annual Meeting showed that patients who received the combination (n = 188) achieved a median OS of 15.97 months (95% CI, 13.47-not reached) compared with 11.50 months (95% CI, 10.02-13.57) among those treated with nab-paclitaxel alone (n = 193; HR, 0.69; 95% CI, 0.52-0.92; log-rank P = .0121). Even though the OS data are not yet mature, the curves have distinctly separated, Olawaiye said. The 12-month OS rates in the combination and control arms were 60% and 49%, he added. Notably, the addition of relacorilant to nab-paclitaxel led to an OS benefit across all the prespecified subgroups presented during the meeting.

Relacorilant plus nab-paclitaxel does not require biomarker testing to be administered, Olawaiye explained. Most pretreated patients with platinum-resistant disease would be eligible to receive the regimen, he added. Relacorilant can also be easily taken by patients since the drug is given orally, Olawaiye said.