Ovarian cancer drug reduces risk of death by 35%
Corcept Therapeutics has announced that ROSELLA, the company’s Phase III trial of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, met its overall survival primary endpoint.
In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 35% reduction in the risk of death compared to patients treated with nab-paclitaxel alone.
The median OS for patients receiving relacorilant was 16 months, compared to 11.9 months for patients receiving nab-paclitaxel alone, a difference of 4.1 months.
Relacorilant in combination with nab-paclitaxel was well-tolerated, consistent with its known safety profile.
Corcept previously announced that ROSELLA also met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR). Patients who received relacorilant in addition to nab-paclitaxel experienced a 30% reduction in the risk of disease progression
“Importantly, the Phase III trial results are not limited to patients with any particular biomarker requirement,” said Alexander Olawaiye, Director of Gynecological Cancer Research at Magee-Women’s Hospital of the University of Pittsburgh and Principal Investigator in the trial. “ROSELLA’s findings compel us to evaluate relacorilant as a treatment for earlier stages of ovarian cancer and for other tumours that express the glucocorticoid receptor (GR), such as endometrial and cervical cancer.”
Relacorilant is a selective GR antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors.
Corcept is currently studying relacorilant in other solid tumours, including platinum-sensitive ovarian, endometrial, cervical, pancreatic and prostate cancers.
Domenica Lorusso, Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X in Milan, and Full Professor of Obstetrics and Gynaecology at Humanitas University, Rozzano and an investigator in the trial, added: “These tumours eventually become resistant to chemotherapy and providing oncologists with relacorilant plus nab-paclitaxel could greatly benefit patients.”