Multinational phase 3 trial of relacorilant plus nab-paclitaxel for platinum-resistant ovarian cancer: overall survival results from ROSELLA

Relacorilant is a selective glucocorticoid receptor antagonist that increases the sensitivity of many cancer cell types to chemotherapy. The phase 3 ROSELLA trial, at 117 centers in 14 countries, showed that the combination of relacorilant and nab-paclitaxel significantly improved progression-free surival compared with nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (PROC). Final overall survival results have now been published. Adult patients with one to three previous lines of therapy were randomized to relacorilant plus nab-paclitaxel (combination group, n=188) or nab-paclitaxel monotherapy (monotherapy group; n=193). At a median follow-up of 24.8 months, the median overall survival was 16.0 months in the combination group versus 11.9 months in the monotherapy group (HR 0.65; p=0.0004). Subsequent anticancer treatments were similar across study groups. Adverse events were similar in both groups when adjusted for duration of study treatment. No new safety signals were observed with additional follow-up since the primary analysis. The authors conclude that addition of relacorilant to nab-paclitaxel led to significantly longer overall survival in patients with PROC.