Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat serious endocrinologic, oncologic, metabolic and neurologic diseases by modulating the effects of the hormone cortisol, today announced that ROSELLA, the company's pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, has met its primary endpoint of improved progression-free survival as determined by a blinded, independent pivotal review (PFS-BICR).
In the ROSELLA study, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy showed a 30 percent reduced risk of disease progression compared to patients receiving nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008). Their median PFS-BICR was 6.5 months compared to 5.5 months in patients receiving nab-paclitaxel alone. In an interim assessment of overall survival (OS), patients treated with relacorilant plus nab-paclitaxel showed a significant improvement in OS with a median OS of 16.0 months compared to 11.5 months in patients receiving nab-paclitaxel alone (hazard ratio: 0.69; p-value: 0.012). Relacorilant was well tolerated and no new safety signals were observed. As in the company's Phase 2 study, safety and tolerability were comparable in both groups.
