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

"We can now share that the progression-free survival end point was met. The study showed a hazard ratio of 0.7, which is [a] 30% reduction in the risk of [disease] progression or death, which was highly statistically significant."

Alexander Olawaiye, MD, professor of gynecologic oncology at the University of Pittsburgh School of Medicine, discussed data from the phase 3 ROSELLA trial (NCT03776812), which evaluated relacorilant—a selective glucocorticoid receptor antagonist—in combination with nab-paclitaxel (Abraxane) vs nab-paclitaxel alone in patients with platinum-resistance epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Data presented by Olawaiye at the 2025 ASCO Annual Meeting showed that the combination of relacorilant and nab-paclitaxel produced a statistically significant improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 30% vs nab-paclitaxel alone (HR, 0.70; 95% CI, 0.54-0.91; log-rank P = .0076). The median PFS was 6.54 months (95% CI, 5.55-7.43) for relacorilant plus nab-paclitaxel (n = 188) vs 5.52 months (95% CI, 3.94-5.88) for nab-paclitaxel alone (n = 193).

Olawaiye explained that the PFS curves started to separate at the first scan following the start of treatment. At 12 months, the PFS rates were 25% and 13% for the experimental and control arms, respectively.

Tolerability of the relacorilant-based regimen was favorable, he continued. The safety profile remained consistent with known toxicities associated with nab-paclitaxel, including manageable rates of neuropathy and hematologic adverse effects (AEs). Importantly, treatment discontinuations due to AEs occurred at rates of 9.0% for the relacorilant arm vs 7.9% for the control arm.