Benzinga | Jun 22, 2021 08:32AM EDT

Corcept Therapeutics Stops Enrollment In RELIANT Trial; Says 'the apparent level of benefit does not justify its further study as a treatment for end-stage pancreatic cancer'

* Enrollment stopped in RELIANT trial

* Antitumor activity observed in heavily pretreated patients with metastatic pancreatic cancer, including those previously treated with nab-paclitaxel; addition of relacorilant to nab-paclitaxel therapy was well-tolerated

* Phase 3 pivotal trial in patients with platinum-resistant ovarian cancer upcoming

* Treatment of patients with earlier line pancreatic cancer as well as patients with other solid tumors will be evaluated

MENLO PARK, Calif., June 22, 2021 (GLOBE NEWSWIRE) -- 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, today announced preliminary results from its Phase 3 RELIANT trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer.

"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."