Company: CORT
Filing Date: 2025-07-31
Form Type: 10-Q
Source: 0001628280-25-037005
Chunk: 23

Company: CORCEPT THERAPEUTICS INC
Filing Date: 2025-07-31
Form: 10-Q
Item: Part I, Item 1
Chunk 23
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 primary endpoints is considered positive if either endpoint is met.

In March 2025, we announced that ROSELLA had met its PFS endpoint. Patients treated with relacorilant in addition to nab-paclitaxel experienced a clinically and statistically significant 30 percent reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008). PFS as assessed by ROSELLA’s clinical investigators was also positive (hazard ratio: 0.71; p-value: 0.0030). Although final data with respect to OS are not yet available, an interim analysis of survival data as of the date of the PFS analysis showed that patients who received relacorilant in addition to nab-paclitaxel had exhibited a meaningful 31 percent reduction in risk of death (hazard ratio: 0.69; p-value: 

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0.012), with a median OS of 16.0 months, compared to 11.5 months in patients receiving nab-paclitaxel alone. Both PFS and OS benefits were seen in all clinically relevant subgroups, including those with poor prognoses. 

Importantly, relacorilant did not increase the safety burden of patients who took it. Relacorilant was well-tolerated and, when adjusted for duration of treatment, the rate, type and severity of adverse events in patients who received it were similar to those experienced by patients who received nab-paclitaxel alone.

The results from ROSELLA were published in The Lancet (Olawaiye et al., June 2025).

ROSELLA’s results have been consistent with the positive results of our Phase 2 trial, a 178-patient, controlled, multi-center, trial of relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer. Phase 2 study participants were randomized to one of three treatment arms: 60 women received 150 mg of relacorilant intermittently (the day before, the day of and the day after their weekly nab-paclitaxel infusion) and 58 women received a daily relacorilant dose of 100 mg per day in addition to nab-paclitaxel. Sixty women received nab-paclitaxel alone. The trial’s primary endpoint was PFS.

Patients in both of the relacor