Clinical Trials

Corcept Therapeutics’ oral ovarian cancer drug relacorilant has improved progression-free survival in the ROSELLA trial.

The international study of 381 patients with platinum-resistant ovarian cancer (PROC) involved relacorilant plus nab-paclitaxel chemotherapy, with those on the combination seeing a 30% reduction in their risk of disease progression compared to nab-paclitaxel alone.

There also appeared to be overall survival (OS) benefits from the combination. An interim evaluation of the data found relacorilant plus nab-paclitaxel had a significant improvement in OS, with a median OS of 16 months, compared to 11.5 months for patients on nab-paclitaxel.

Corcept’s chief development officer Bill Guyer said: “The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standardof-care treatment for patients with PROC.

“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. We expect to submit our NDA in the third quarter and our MAA shortly thereafter.”

Relacorilant is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not other hormone receptors. In addition to studying ovarian cancer, Corcept is researching relacorilant’s use against other cancers including prostate cancer.

Often difficult to detect in its early stages, 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 considered to have platinum-resistant disease (PROC). There are currently only a limited number of treatments available for these women.

Alexander Olawaiye, director of gynaecological cancer research at Magee-Women’s Hospital of the University of Pittsburgh, US and principal investigator in the ROSELLA trial, said: “Patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies.

“The ROSELLA results represent an important advancement in the development of a treatment for patients with PROC.”