Dr Olawaiye on Phase 2 Data With Relacorilant and Nab-Paclitaxel in Ovarian Cancer

“In the phase 2 study, we demonstrated that [relacorilant] combined with nab-paclitaxel extended PFS [vs nab-paclitaxel monotherapy] in patients with platinum-resistant ovarian cancer.”

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 prior data with relacorilant plus nab-paclitaxel (Abraxane) in patients with platinum-resistant ovarian cancer that led to the initiation of thephase 3 ROSELLA trial (NCT05257408).

Relacorilant is an oral, selective glucocorticoid receptor antagonist, Olawaiye explained. Prior to the initiation of ROSELLA, the agent was evaluated in combination with nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer in a phase 2 study (NCT03776812), he added.

Data from the phase 2 study showed that intermittent relacorilant plus nab-paclitaxel extended progression-free survival (PFS) compared with nab-paclitaxel monotherapy (HR, 0.66; 95% CI, 0.44-0.98; P = .038), Olawaiye said. At a median follow-up of 11.1 months, the median PFS among evaluable patients in the combination (n = 60) and monotherapy (n = 60) arms was 6.5 months vs 3.8 months, respectively.

ROSELLA was the confirmatory trial of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer, Olawaiye said. Patients were randomly assigned 1:1 to receive relacorilant at 150 mg plus intravenous (IV) nab-paclitaxel at 80 mg/m2, or IV nab-paclitaxel at 100 mg/m2, he added. Eligible patients needed to have an ECOG performance status of 0 or 1, have received 1 to 3 prior lines of therapy—including bevacizumab (Avastin), and have experienced disease progression less than 6 months after the last dose of platinum therapy. The dual primary end points were PFS per RECIST 1.1 criteria by blinded independent central review and overall survival. Secondary end points included overall response rate, duration of response, and safety.

Interim results from ROSELLA presented during the 2025 ASCO Annual Meeting demonstrated that patients who received relacorilant plus nab-paclitaxel (n = 188) experienced a 31% reduction in the risk of death compared with those who received nab-paclitaxel alone (n = 193; HR, 0.69; 95% CI, 0.52-0.92; log-rank P = .0121).