Corcept Therapeutics announced that its investigational drug relacorilant, when combined with chemotherapy, significantly improved overall survival in patients with platinum-resistant ovarian cancer during a Phase III clinical trial. The study, known as ROSELLA, showed that patients receiving relacorilant plus nab-paclitaxel experienced a 35% reduction in the risk of death from all causes compared to those who received chemotherapy alone. Median overall survival for the combination group was 16 months, while it was 11.9 months for the control group.
Analysts at Truist Securities described the survival benefit as “robust.” They stated: “These findings… look competitive with the 32% OS benefit reported for AbbVie’s folate receptor antagonist Elahere, and with the 24% for Merck’s blockbuster PD-1 inhibitor Keytruda. Relacorilant’s reduction in death risk… represents a ‘meaningful advance in [platinum-resistant ovarian cancer] where chemotherapy historically delivers only modest survival gains.’” Truist also noted: “This tolerability advantage materially improves the regimen’s real-world competitiveness.”
Corcept's stock price rose by 6.5% to $43.98 following the announcement.
Interim data released last year indicated that relacorilant improved progression-free survival by 30% compared to nab-paclitaxel alone—a statistically significant result.
Safety data released alongside efficacy results showed that toxicities were similar between those treated with relacorilant and those on chemotherapy alone. Truist found this aspect of safety encouraging, particularly because there was “no added toxicity even in a heavily pre-treated population.”
Relacorilant is an oral selective glucocorticoid receptor blocker designed to modulate cortisol activity. This mechanism may make it suitable for other conditions related to cortisol dysregulation.
The FDA accepted Corcept’s new drug application for relacorilant in platinum-resistant ovarian cancer last September, with a decision expected by July 11.
In December 2024, Corcept also sought approval of relacorilant for hypercortisolism but received a rejection from the FDA last month due to insufficient evidence supporting its risk-benefit profile.
