Trial: Relacorilant aids survival in platinum-resistant ovarian cancer
Developer to seek therapy’s US, EU approval based on Phase 3 study results
Adding relacorilant to standard chemotherapy was shown to extend survival among people with platinum-resistant ovarian cancer, meeting the primary endpoint, or goal, of a Phase 3 clinical trial, according to top-line results.
Based on these new data, relacorilant’s developer Corcept Therapeutics is planning to apply for regulatory approval of the therapy in the U.S. and the European Union, the company said in a press release.
“The improvement in survival … without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, Corcept’s chief development officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look forward to presenting the trial’s full results in the coming months.”
Guyer said the application in the U.S. is expected in the third quarter of this year, or by the end of September, with a submission in the EUcoming “shortly thereafter.”
Risk of worsening disease reduced by 30% with relacorilant add-on
Platinum-based chemotherapy drugs are a standard first-line treatment for ovarian cancer. However, if the cancer is resistant to these drugs, then treatment options are limited. Surgery may not be possible if the cancer has spread extensively or the patient is not healthy enough for such a procedure.
Relacorilant is an oral therapy that works to block the activity of receptors for cortisol, a stress hormone that according to Corcept can help cancers resist chemotherapy.
The Phase 3 ROSELLA clinical trial (NCT05257408) enrolled 381 people with platinum-resistant ovarian cancer at 117 locations across the globe. Participants were randomly assigned to receive relacorilant in combination with a standard chemotherapy called nab-paclitaxel, or nab-paclitaxel alone.
The study’s main goals were to evaluate the effect of adding relacorilant treatment on overall survival as well as progression-free survival, meaning the amount of time patients stayed alive without their cancer growing.
According to Alexander B. Olawaiye, MD, the study’s principal investigator at Magee-Women’s Hospital of the University of Pittsburgh, “the ROSELLA results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer.” Olawaiye noted that “patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies.”
The trial results showed that adding relacorilant to nab-paclitaxel chemotherapy lowered the risk of disease worsening by 30% compared with chemotherapy alone.
The ROSELLA results demonstrate that relacorilant in combination with nab-paclitaxel has the potential to become a key strategy to help improve patient outcomes.
Specifically, median progression-free survival was longer in patients given relacorilant (6.5 vs. 5.5 months). Median overall survival time was also significantly longer with relacorilant plus nab-paclitaxel than with nab-paclitaxel alone (16 vs. 11.5 months).
The addition of relacorilant did not lead to any substantial safety issues; safety findings were similar in both treatment groups.
Domenica Lorusso, MD, PhD, a study investigator at Humanitas University in Italy, agreed that “platinum-resistant ovarian cancer poses a significant treatment challenge” for patients and their doctors.
“The ROSELLA results demonstrate that relacorilant in combination with nab-paclitaxel has the potential to become a key strategy to help improve patient outcomes,” Lorusso said.
Corcept is also developing relacorilant as a potential treatment for Cushing’s syndrome, a disease driven by excess cortisol levels.
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