Treatment with relacorilant plus standard chemotherapy was shown in a clinical trial to significantly improve survival compared with chemo alone for people with hard-to-treat ovarian cancer.
That’s according to new data announced by relacorilant’s developer Corcept Therapeutics, which showed that adding the experimental therapy to chemotherapy helped extend survival for patients with platinum-resistant ovarian cancer. The therapy combo is being tested in a large Phase 3 clinical trial, dubbed ROSELLA (NCT05257408), that involves individuals who have already received at least one line of treatment.
These new findings, when combined with earlier trial results, suggest that relacorilant’s use as an add-on therapy can extend both overall and progression-free survival for people with this type of gynecological cancer, Corcept stated in a company press release.
“The addition of relacorilant to nab-paclitaxel, a trusted and effective chemotherapy, is positioned to become a new standard-of-care treatment for patients with platinum-resistant ovarian cancer, due to its overall survival benefit, well tolerated side effect profile and oral administration,” said Alexander B. Olawaiye, MD, chief investigator of the Phase 3 study at the University of Pittsburgh in Pennsylvania.
The trial enrolled 381 people with ovarian cancer that was resistant to standard platinum-based chemotherapies. To be eligible, participants had to have previously received one to three lines of treatment, including at least one line of platinum chemotherapy and one round of treatment with the approved therapy bevacizumab (sold as Avastin, among others). Olawaiye noted that the study was “not limited to patients with any particular biomarker requirement.”
All participants in the ROSELLA study received nab-paclitaxel, a standard chemotherapy regimen. Half of the patients were also given relacorilant, while the other half got chemotherapy alone. The study’s main goals were to see if the addition of relacorilant delayed disease progression and prolonged survival.
Relacorilant already shown to reduce risk of disease progression
Corcept previously announced that the study had met its first goal: The risk of disease progression was reduced by about 30% in patients who received relacorilant.
Now, the company announced that the trial also met its second goal. Specifically, median survival time was significantly longer in patients given relacorilant (16 vs. 11.9 months), resulting in a 35% reduction in the risk of death.
“These data clearly demonstrate the potential of relacorilant plus nab-paclitaxel to extend overall and progression-free survival in patients with advanced, recurrent ovarian cancer,” said Domenica Lorusso, MD, PhD, of Humanitas Hospital San Pio X and Humanitas University in Italy, who’s also an investigator in the ROSELLA trial.
“These tumors eventually become resistant to chemotherapy and providing oncologists with relacorilant plus nab-paclitaxel could greatly benefit patients,” Lorusso said.
These data clearly demonstrate the potential of relacorilant plus [a standard chemotherapy regimen] to extend overall and progression-free survival in patients with advanced, recurrent ovarian cancer.
Among cancer patients, signaling by the stress hormone cortisol can promote resistance to chemotherapy in cancer cells, contributing to poorer clinical outcomes. Ovarian cancer cells express glucocorticoid receptors — proteins that mediate the effects of cortisol — on their surface.
Relacorilant is an oral medication designed to block glucocorticoid receptors, with the aim of reducing cancer growth and also making chemotherapy more effective.
Regulatory decision on therapy’s use in US expected this summer
Applications seeking approval of relacorilant for platinum-resistant ovarian cancer are currently under review by authorities in the U.S. as well as the European Union.
Bill Guyer, Corcept’s chief development officer, said the company is working with regulatory authorities on both continents “to bring this much-needed new treatment to patients as soon as possible.” In the U.S., the Prescription Drug User Fee Act target action date is coming up on July 11.
Corcept is also exploring relacorilant’s potential in other diseases, including earlier stages of ovarian cancer and other types of gynecological cancers, Olawaiye noted.
“ROSELLA’s findings compel us to evaluate relacorilant as a treatment for earlier stages of ovarian cancer and for other tumors that express the glucocorticoid receptor, such as endometrial and cervical cancer,” Olawaiye said.
Corcept previously applied for U.S. approval of relacorilant to treat high blood pressure associated with elevated cortisol levels. But a few weeks ago, the U.S. Food and Drug Administration rejected the application, saying available data do not prove that the therapy’s benefits outweigh its risks in that indication.
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