Approval sought of relacorilant for platinum-resistant ovarian cancer
Therapy would be used with standard chemotherapy agent
Corcept Therapeutics has asked the U.S. Food and Drug Administration (FDA) to approve relacorilant, to be used in combination with the standard chemotherapy agent nab-paclitaxel, for treating platinum-resistant ovarian cancer.
The application is supported by positive data from the pivotal Phase 3 ROSELLA clinical trial (NCT05257408) and other Phase 2 studies, where relacorilant on top of nab-paclitaxel led to slower disease progression and prolonged survival relative to chemotherapy alone. Relacorilant is also being reviewed for endogenous Cushing’s syndrome, a condition where levels of the stress hormone cortisol are too high.
“This submission is an important milestone for Corcept,” Joseph K. Belanoff, MD, Corcept’s CEO, said in a company press release. “Better treatment options are needed for the many patients living with these diseases.” Belanoff said the company is “already working to make sure relacorilant is available immediately following regulatory approval.”
Meanwhile, an open-label Phase 2 trial called BELLA (NCT06906341) is recruiting around 90 adults with recurrent, platinum-resistant ovarian cancer in the U.S., Belgium, France, Italy, Poland, and Korea. The study is testing the efficacy of relacorilant when combined with nab-paclitaxel and the antibody-based therapy bevacizumab, which blocks new blood vessels from forming that tumors need to grow and survive.
Treating ovarian cancer
First-line ovarian cancer treatment often involves a combination of surgery and platinum-based chemotherapy drugs. Sometimes, this form of gynecological cancer becomes resistant to these medications, however, which limits treatment options.
One way cancer cells resist chemotherapy is through signaling of cortisol at glucocorticoid receptor proteins on their surface. Cortisol helps prevent cancer cell death and suppress the immune responses needed to fight cancer. It can sometimes activate cancer-promoting genes. An oral therapy, relacorilant is designed to block glucocorticoid receptors and reduce cortisol signaling. This should increase cancer cells’ sensitivity to chemotherapy and make treatment more effective.
Published results from ROSELLA showed it met its main goal, with relacorilant with nab-paclitaxel significantly prolonging the time spent alive without cancer growth, or progression free survival, relative to nab-paclitaxel alone among adults with platinum-resistant ovarian cancer. The difference amounted to a 30% lower risk of disease progression with relacorilant. The combination was also associated with prolonged overall survival in interim analyses.
Relacorilant was effective across key patient subgroups, including when separated by age, previous therapies, and other prognostic markers. This means the drug has the potential to be broadly used without the need for a biomarker-based selection of eligible patients, according to Corcept. Relacorilant was also well tolerated and didn’t lead to any additional safety burden over chemotherapy alone.
In BELLA, all the participants will receive a combination of relacorilant, nab-paclitaxel, and bevacizumab until they experience disease progression, unmanageable toxicity, or meet other discontinuation criteria. The main goal is to evaluate progression-free survival for up to 1.5 years. Treatment response rates, overall survival, and safety will also be assessed.
Corcept is also evaluating relacorilant as a possible treatment for prostate cancer.
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