Relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer

Results from the ROSELLA phase 3 trial, recently published on The Lancet, shows that adding relacorilant to nab-paclitaxel improved overall survival versus nab-paclitaxel alone in patients with platinum-resistant ovarian cancer, without the need for biomarker selection.

In the multicenter ROSELLA phase 3 trial, a total of 381 patients with ovarian carcinoma exposed to one to three lines of previous anticancer therapy and platinum-resistant disease were randomized to receive relacorilant plus nab-paclitaxel or nab-paclitaxel monotherapy; all patients had received bevacizumab, 61% had received a PARP inhibitor. At a median follow-up of 24.8 months, the addition of relacorilant to nab-paclitaxel resulted in a statistically and clinically significant improvement in overall survival compared with nab-paclitaxel monotherapy; 18-month overall survival was 46% and 27%, respectively. The median overall survival in the relacorilant combination group was extended to 16 months, whereas it was 11.9 months in the nab-paclitaxel monotherapy group. Adverse events were similar in both groups  and no new safety signals were observed. As authors point out, «This study is the first positive clinical trial conducted with registrational intent for a selective glucocorticoid receptor antagonist in patients with cancer. The data supports the ongoing evaluation of relacorilant in other solid tumour indications and in combination with other classes of anticancer agents. These outcomes, namely a 35% reduction of the risk of death from any cause and a median overall survival improvement of 4.1 months, position relacorilant plus nab-paclitaxel as a new standard treatment option for patients with platinum-resistant ovarian cancer, without the need for biomarker selection», they conclude.