Company: CORT
Filing Date: 2025-07-31
Form Type: 10-Q
Source: 0001628280-25-037005
Chunk: 51

Company: CORCEPT THERAPEUTICS INC
Filing Date: 2025-07-31
Form: 10-Q
Item: Part I, Item 8
Chunk 51
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 2 trials. Patients in these trials exhibited clinically meaningful improvements in progression free survival (“PFS”) and overall survival (“OS”). Relacorilant was well-tolerated and did not increase the safety burden of patients who took it.

ROSELLA enrolled three hundred eighty-one women with recurrent, platinum-resistant ovarian cancer who were randomized 1:1 to receive either 150 mg of relacorilant intermittently in addition to the chemotherapeutic agent nab-paclitaxel or nab-paclitaxel monotherapy. Patients enrolled in ROSELLA received prior bevacizumab therapy, which is the approved standard of care for patients with platinum-resistant ovarian cancer. Women who have received more than three prior lines of therapy were excluded. ROSELLA has dual primary endpoints – PFS as assessed by blinded independent central review and OS. A study with dual 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