On September 17, 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 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) (Free ESMO Whitepaper) Congress 2021 (Press release, Corcept Therapeutics, SEP 17, 2021, https://ir.corcept.com/news-releases/news-release-details/positive-results-presented-esmo-2021-randomized-controlled-phase [SID1234587878]).

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"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 (Free ESMO Whitepaper) 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 63% mature at the time of the database cut-off (March 2021), the women in the Intermittent arm exhibited a median OS of 12.9 months versus 10.4 months in the Comparator arm (see Table 1).

Intermittent Comparator Intermittent vs Comparator
Median PFS
(95% CI) 5.6 months 3.8 months Hazard Ratio: 0.66 (0.44, 0.98)

p-value: <0.05
Median DoR
(95% CI) 5.6 months 3.7 months Hazard Ratio: 0.36 (0.16, 0.77)

p-value: 0.006
Median OS
(63% maturity) 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 (Free ESMO Whitepaper) 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.