On June 22, 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 preliminary results from its Phase 3 RELIANT trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer (Press release, Corcept Therapeutics, JUN 22, 2021, https://ir.corcept.com/news-releases/news-release-details/preliminary-results-reliant-trial-relacorilant-plus-nab [SID1234584221]).
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"RELIANT evaluated relacorilant plus nab-paclitaxel in pancreatic cancer patients who had relapsed following at least two prior lines of therapy, including treatment with nab-paclitaxel in almost all cases," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Two of 31 evaluable patients exhibited tumor shrinkage designated as a partial response, a response rate of six percent, while 15 patients achieved stable disease for at least 12 weeks. The combination was well-tolerated. These data are similar to those of our Phase 1 study.
"Metastatic pancreatic cancer is a dire disease and patients who have relapsed following multiple lines of therapy have no effective treatment options. While our interim analysis suggests that the combination of relacorilant and nab-paclitaxel is active in these patients, the apparent level of benefit does not justify its further study as a treatment for end-stage pancreatic cancer."
"All of the cancers we are studying are aggressively lethal and we will not pursue an approval unless we believe our candidate therapy offers a substantial benefit," added Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Our development program in solid tumors continues to advance. Based on the positive results of our controlled Phase 2 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, we are very excited to initiate a pivotal trial for that indication in the first quarter of 2022. Our trials of relacorilant plus pembrolizumab in patients with adrenal cancer and of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer continue to enroll. Based on the promising clinical trial results we have observed across our oncology programs, we are evaluating relacorilant as a potential treatment for patients with earlier stages of pancreatic cancer and with other glucocorticoid receptor-expressing tumors."
Trial Design and Preliminary Results
RELIANT is a single-arm, multicenter, open-label, Phase 3 trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer, with a planned enrollment of 80 patients and a planned interim analysis of outcomes in the first 40 patients. Patients received 100 mg of relacorilant every day and 80 mg/m2 nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle. RELIANT’s primary endpoint is objective response rate.
At the planned interim analysis, the study had enrolled 43 patients with metastatic pancreatic cancer who had received 2-4 prior lines of therapy (median prior lines of therapy: three), including 40 patients who were previously treated with nab-paclitaxel. As of the database cutoff date of April 15, 2021, there were 31 efficacy-evaluable patients. Two of these patients (six percent) had a partial response (best response based on RECIST v1.1); and 15 patients (48 percent) had stable disease, with two patients (six percent) with stable disease greater than 18 weeks. Safety was consistent with known profiles for relacorilant and nab-paclitaxel.
About Relacorilant
Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, pancreatic and castration-resistant prostate cancer, as well as 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.