Corcept Therapeutics announced that its pivotal Phase 3 ROSELLA trial, evaluating relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, met its primary endpoint of improved progression-free survival (PFS-BICR). Patients treated with the combination therapy experienced a 30 percent reduction in the risk of disease progression compared to those receiving nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008).
The trial also demonstrated a significant improvement in overall survival (OS) at an interim evaluation, with patients receiving relacorilant plus nab-paclitaxel achieving a median OS of 16.0 months, compared to 11.5 months for patients on nab-paclitaxel alone (hazard ratio: 0.69; p-value: 0.012). These results indicate a meaningful clinical benefit for patients with this challenging cancer.
Relacorilant was well-tolerated in the study, with no new safety signals observed, and safety and tolerability were comparable between the treatment groups. Corcept plans to submit a New Drug Application (NDA) for relacorilant in platinum-resistant ovarian cancer in the third quarter of this year, opening a major new therapeutic area for the company.
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