On May 6, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported positive results from its 178-patient, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, MAY 6, 2021, https://ir.corcept.com/news-releases/news-release-details/addition-relacorilant-nab-paclitaxel-improves-progression-free [SID1234579334]).

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Women with platinum resistant ovarian cancer (n=60) who received 150 mg of relacorilant the day before, the day of and the day after their weekly nab-paclitaxel infusion exhibited a statistically significant improvement in progression free survival (hazard ratio 0.66, p-value 0.038) compared to women (n=60) who received nab-paclitaxel monotherapy; their median progression free survival was 1.8 months longer (5.6 vs 3.8 months). Safety data and tolerability data for the two groups were comparable. (See Figure 1)

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A third cohort of patients (n=58) received a daily dose of relacorilant (100 mg per day, with titration to 150 mg per day at the investigator’s discretion) in addition to nab-paclitaxel. These patients’ median progression-free survival increased 1.5 months compared to the control arm, to 5.3 months, but this improvement did not reach statistical significance (hazard ratio 0.83).

"It’s impressive how this therapy extends the benefits of taxanes," said Professor Pamela Munster, MD, Director of the University of California San Francisco’s Early Phase Clinical Trials Unit and Co-leader of its Center for BRCA Research. "Patients with platinum-resistant ovarian cancer have few good treatment options. A therapy that significantly extends time to tumor progression without additional side effect burden would be an important advance."

Corcept has begun planning a pivotal Phase 3 trial.

About the Trial

This controlled, multi-center, Phase 2 trial enrolled 178 patients with platinum-resistant ovarian cancer in one of three study arms. Sixty patients received 150 mg relacorilant the day before, the day of and the day after their infusion of nab-paclitaxel. Fifty-eight patients received 100 mg relacorilant every day, with titration up to 150 mg permitted at the investigator’s discretion. The sixty patients in the control arm received nab-paclitaxel alone. All patients received nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle. Patients in the control arm received 100 mg/m2 of nab-paclitaxel. Because relacorilant increases nab-paclitaxel plasma levels, the nab-paclitaxel dose in patients receiving relacorilant was 80 mg/m2. The trial’s primary endpoint was progression free survival. Secondary endpoints include overall survival, objective response rate and duration of response. The trial is being conducted at 28 sites in the United States and Europe. Additional information about the study (NCT03776812) can be obtained at www.ClinicalTrials.gov.

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, pancreatic and castration-resistant prostate cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It has received orphan drug designation in the United States for the treatment of Cushing’s syndrome and pancreatic cancer.