Patients with platinum-resistant ovarian cancer generally have a poor prognosis. The patients included in this study had previously been treated with bevacizumab and a taxane. The majority had received at least one prior treatment line in the platinum-resistant setting as well as a previous PARP inhibitor.
In this study, patients were randomized (1:1) to receive nab-paclitaxel alone or in combination with relacorilant. Nab-paclitaxel was administered in monthly cycles consisting of three administrations followed by one week of rest. Relacorilant was administered the day before, the day of, and the day after chemotherapy.
Nab-paclitaxel was selected because it is an albumin-bound formulation of paclitaxel. This formulation reduces the risk of allergic reactions and eliminates the need for corticosteroid premedication. Since relacorilant is a glucocorticoid receptor antagonist, avoiding corticosteroid administration is essential to prevent pharmacological interference.
The interim analysis demonstrated an improvement in progression-free survival (5.52 versus 6.54 months) and overall survival (11.50 versus 15.97 months). These findings confirm the results of a previous phase II study, which had already shown an improvement in progression-free survival from 3.8 to 5.6 months.
The most frequently observed adverse events with the combination of nab-paclitaxel and relacorilant were neutropenia, anemia, fatigue, and nausea. The safety profile of the combination was comparable to that of nab-paclitaxel monotherapy.
The combination of relacorilant and nab-paclitaxel improves progression-free survival in patients with platinum-resistant ovarian cancer compared with weekly taxane monotherapy. The clinically significant improvement observed in both progression-free and overall survival highlights the potential importance of adding relacorilant to nab-paclitaxel therapy.