On June 27, 2023 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported publication of the final analysis from its Phase 2 trial evaluating its proprietary cortisol modulator, relacorilant, in women with platinum-resistant ovarian cancer in the Journal of Clinical Oncology (JCO), the premiere journal of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Corcept Therapeutics, JUN 27, 2023, https://ir.corcept.com/news-releases/news-release-details/journal-clinical-oncology-publishes-results-corcepts-phase-2 [SID1234632930]).
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The publication is titled Relacorilant + Nab-Paclitaxel in Patients with Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study and can be accessed at the following link: View Source
In the trial, patients who received relacorilant orally the day before, the day of and the day after their nab-paclitaxel infusion ("intermittent dosing") experienced a 34 percent reduction in risk of disease progression (median PFS=5.6 vs. 3.8 months, HR 0.66, P=0.038), responded to treatment longer (median DoR=5.6 vs. 3.7 months, HR 0.36, P=0.006) and had a 33 percent reduction in risk of death (median OS=13.9 vs. 12.2 months, HR 0.67, P=0.066) compared to patients who received nab-paclitaxel alone. Adverse events were comparable across the study arms.
PFS and OS benefits were exhibited across multiple subgroups of patients. Patients who would have met the eligibility requirements for Corcept’s confirmatory Phase 3 ROSELLA trial did especially well. A post-hoc analysis showed that patients who had received prior bevacizumab, did not have primary platinum-refractory disease and who had received no more than three prior lines of therapy experienced a 62 percent reduction in risk of death (median OS=17.9 vs. 12.6 months, HR 0.38, P=0.011) compared to similar patients who received nab-paclitaxel alone.
"Outcomes for patients with platinum-resistant ovarian cancer are poor and treatment options are limited," said first author of the publication Nicoletta Colombo, MD, PhD, Associate Professor, Obstetrics and Gynecology, University of Milan-Bicocca, Director, Ovarian Cancer Center, and Chair, Program of Gynecology, European Institute of Oncology, IRCCS, Milan Italy. "The benefits experienced by patients in the intermittent dosing group are meaningful especially given the simple, oral dosing and favorable safety profile of relacorilant. We are on the cusp of developing an entirely new way to treat this serious disease."
"We are excited by the data from our Phase 2 trial and enthusiastic the results have been published in the Journal of Clinical Oncology. Our single goal is to replicate the great results seen in our phase 2 trial," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "We believe relacorilant has the potential to become a new standard of care for all patients with platinum-resistant ovarian cancer."
About Platinum-Resistant Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy are described as having "platinum-resistant" disease. In the United States, approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year. There are few treatment options and median overall survival following recurrence of disease is typically 12 months or less with single-agent chemotherapy.