Company: CORT
Filing Date: 2025-05-05
Form Type: 10-Q
Source: 0001628280-25-022173
Chunk: 21

Company: CORCEPT THERAPEUTICS INC
Filing Date: 2025-05-05
Form: 10-Q
Item: Part I, Item 1
Chunk 21
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el. Sixty women received nab-paclitaxel alone. The trial’s primary endpoint was PFS.

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Patients in both of the relacorilant plus nab-paclitaxel treatment arms of the Phase 2 trial experienced longer PFS than did the patients who received nab-paclitaxel alone. Patients who received a higher dose of relacorilant intermittently exhibited a statistically significant improvement in median PFS (5.6 months versus 3.8 months, hazard ratio: 0.66; p-value: 0.038). Patients who received a lower dose of relacorilant daily exhibited a median PFS that was 1.5 months longer than did the patients who received nab-paclitaxel alone (5.3 months versus 3.8 months, hazard ratio: 0.83; p-value: not significant). Patients who received relacorilant intermittently also had a longer median duration of response (“DoR”) (5.6 months versus 3.7 months, hazard ratio: 0.36; p-value: 0.006) compared to those who received nab-paclitaxel alone. Patients who received relacorilant intermittently also lived longer (median OS: 13.9 months versus 12.2 months, hazard ratio: 0.67; p-value: 0.066) compared to those who received nab-paclitaxel alone.

Notably, the addition of relacorilant to treatment with nab-paclitaxel did not create an additional adverse event burden for patients. Safety and tolerability of relacorilant and nab-paclitaxel combination treatment were comparable to the safety and tolerability of nab-paclitaxel monotherapy.

The final analysis from our Phase 2 trial was published in the Journal of Clinical Oncology (Colombo et al., 2023), the premiere journal of the American Society of Clinical Oncology (ASCO).

In April 2025, we initiated a Phase 2 trial (“BELLA”) of relacorilant plus nab-paclitaxel and bevacizumab evaluating efficacy and safety in patients with platinum-resistant ovarian cancer. BELLA is a single-arm, open-label trial with a planned enrollment of 90 patients.

The EC has designated relacorilant as an orphan drug for the treatment of ovarian cancer.

Relacorilant in Patients with Ad