Positive Results Presented at ESMO 2021 From Randomized, Controlled, Phase 2 Trial of Relacorilant in Patients with Recurrent Platinum-Resistant Ovarian Cancer
Corcept Therapeutics (NASDAQ: CORT) announced encouraging results from a Phase 2 trial involving 178 patients with recurrent platinum-resistant ovarian cancer. The trial, featured at ESMO 2021, showed that women treated with nab-paclitaxel and relacorilant experienced significant improvement in progression-free survival (PFS). The Intermittent arm demonstrated a median PFS of 5.6 months compared to 3.8 months in the Comparator arm. Corcept plans to initiate a pivotal Phase 3 trial in early 2022 to confirm these findings.
- Statistically significant improvement in median progression-free survival (PFS): 5.6 months vs. 3.8 months (hazard ratio: 0.66; p-value: <0.05).
- Significant improvement in duration of response (DoR): 5.6 months vs. 3.7 months (hazard ratio: 0.36; p-value: 0.006).
- Safety profile of relacorilant comparable to nab-paclitaxel alone.
- Overall survival (OS) data only 63% mature at database cut-off, indicating potential uncertainties.
- Data from Corcept’s 178-patient, randomized, controlled, Phase 2 trial featured in a proffered paper oral presentation at ESMO 2021
- Results show statistically significant and clinically relevant benefit experienced by women with recurrent platinum-resistant ovarian cancer who were treated with nab-paclitaxel plus Corcept’s proprietary selective cortisol modulator, relacorilant
MENLO PARK, Calif., Sept. 17, 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 that results from its 178-patient, randomized, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer were featured in a proffered paper oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021.
“Women with recurrent platinum-resistant ovarian cancer have few therapeutic options,” said William Guyer, PharmD, Corcept’s Chief Development Officer. “The results presented at ESMO today clearly demonstrate the benefit experienced by the women who received relacorilant – delayed disease progression without increased side effect burden. We and our investigators are excited to begin a pivotal Phase 3 trial in the first quarter of next year to confirm these results.”
Women who entered the trial were randomized 1:1:1 to receive either (i) nab-paclitaxel plus 150 mg of relacorilant given the day before, the day of, and the day after each weekly nab-paclitaxel infusion (“Intermittent” arm) (ii) nab-paclitaxel plus 100 mg relacorilant given daily (“Continuous” arm), or (iii) nab-paclitaxel alone (“Comparator” arm). While women in both relacorilant treatment arms experienced an improvement in progression free survival relative to the Comparator arm, the improvement in the Intermittent arm was statistically significant. Safety and tolerability of relacorilant plus nab-paclitaxel was comparable to nab-paclitaxel monotherapy.
Intermittent Arm versus Comparator Arm:
Women who received the higher dose of relacorilant intermittently exhibited a statistically significant improvement in median progression free survival (PFS) compared to those who received nab-paclitaxel alone (median PFS: 5.6 months versus 3.8 months, hazard ratio: 0.66; p-value: <0.05). The women in the Intermittent arm also experienced a statistically significant improvement in the duration of response (DoR) relative to those in the Comparator arm (median DoR: 5.6 months versus 3.7 months, hazard ratio: 0.36; p-value: 0.006). While the overall survival (OS) data was only
| Intermittent | Comparator | Intermittent vs Comparator | |
| Median PFS ( | 5.6 months | 3.8 months | Hazard Ratio: 0.66 (0.44, 0.98) p-value: <0.05 |
| Median DoR ( | 5.6 months | 3.7 months | Hazard Ratio: 0.36 (0.16, 0.77) p-value: 0.006 |
| Median OS ( | 12.9 months | 10.4 months | Hazard Ratio: 0.63 (0.35, 1.14) p-value: 0.12 |
| Table 1: Summary of results of Intermittent and Comparator arms. PFS: progression free survival; ORR: objective response rate; DoR: duration of response; OS: overall survival. | |||
The presentation at ESMO is available at www.corcept.com/research-pipeline/publications. 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, adrenal 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.
About Corcept Therapeutics
Corcept is 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 the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing’s syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.
Forward Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties concern, but are not limited to, the design and results of our clinical trials; our ability to achieve our goals during the COVID-19 pandemic; the development of relacorilant as a treatment for ovarian cancer, including its clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. In this press release, forward-looking statements, include those concerning the clinical attributes of relacorilant and its potential benefits in patients with ovarian cancer, results of our Phase 2 trial and our planning for a Phase 3 pivotal trial. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website. We disclaim any intention or duty to update forward-looking statements made in this press release.
CONTACT:
Corcept Therapeutics
Investor Relations
ir@corcept.com
www.corcept.com
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