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, today announced 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).
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:
https://ascopubs.org/doi/full/10.1200/JCO.22.02624
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.
About Corcept’s Oncology
Programs
There is substantial evidence that cortisol
activity at the glucocorticoid receptor (“GR”) allows certain solid
tumors to resist treatment and that modulating cortisol’s activity
may help anti-cancer treatments achieve their intended effect.
Many types of solid tumors express the GR and
are potential targets for cortisol modulation therapy. In some
cancers, cortisol inhibits cellular apoptosis – the tumor-killing
effect many treatments are meant to stimulate. In other cancers,
cortisol activity promotes tumor growth. Cortisol also suppresses
the body’s immune response; activating – not suppressing – the
immune system is beneficial in fighting certain cancers.
Corcept is conducting clinical trials of its
proprietary selective cortisol modulators in combination with three
different anti-cancer treatments in patients with ovarian, adrenal
and prostate cancers.
About Relacorilant
Relacorilant is a non-steroidal, selective
glucocorticoid receptor modulator 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
prostate cancer and Cushing’s syndrome. Relacorilant is proprietary
to Corcept and is protected by composition of matter and method of
use patents, as well as orphan drug designation in the United
States for the treatment of pancreatic cancer and
both the United States and the European
Union for the treatment of Cushing’s syndrome.
About Corcept
Therapeutics
Corcept has discovered a large portfolio of
proprietary compounds that selectively modulate the effects of
cortisol and owns extensive United States and foreign intellectual
property covering both their composition and their use to treat a
variety of serious disorders. Clinical trials are being conducted
with the company’s leading selective cortisol modulators as
potential treatments for patients with serious disorders –
Cushing’s syndrome, ovarian, prostate and adrenal cancer, ALS,
post-traumatic stress disorder and liver disease. Corcept’s drug
Korlym® was the first medication approved by the U.S. Food and Drug
Administration for the treatment of patients with Cushing’s
syndrome.
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 include, but are not limited to, our ability to
operate our business, conduct our clinical trials and achieve our
other goals during the COVID-19 pandemic; risks related to the
development of relacorilant and other product candidates, including
their clinical attributes, regulatory approvals, mandates,
oversight and other requirements; and the scope and protective
power of our intellectual property. These and other risks are set
forth in our SEC filings, which are available at our
website and the SEC’s website.
In this press release, forward-looking
statements include those concerning the development of relacorilant
as a treatment for ovarian cancer, including its clinical
attributes, regulatory approvals, mandates, oversight, and other
requirements; the potential for relacorilant plus nab-paclitaxel to
become a standard of care for patients with recurrent
platinum-resistant ovarian cancer; and our Phase 3 ROSELLA trial.
We disclaim any intention or duty to update forward-looking
statements made in this press release.
CONTACT:Corcept TherapeuticsFor
Investor inquiries:ir@corcept.com For Media
inquiries:CorceptCommunications@corcept.com www.corcept.com
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