Dr Lorusso on Relacorilant Plus Nab-Paclitaxel in Recurrent, Platinum-Resistant Ovarian Cancer

Domenica Lorusso, MD, PhD, director, Gynaecological Oncology Unit, Humanitas Hospital San Pio X, Milan; full professor, Obstetrics and Gynaecology, Humanitas University, discusses findings from a phase 2 trial (NCT03776812)evaluating the selective glucocorticoid receptor modulator relacorilant (CORT125134) in combination with nab-paclitaxel (Abraxane) in patients with recurrent, platinum-resistant ovarian cancer.

Relacorilant has demonstrated the ability to restore chemosensitivity and improve the efficacy of nab-paclitaxel in patients with recurrent, platinum-resistant, high-grade serous ovarian cancer, Lorusso begins. These patients are characterized by elevated endogenous cortisol levels, which are associated with tumor progression, she says. A phase 1 trial (NCT02762981) showed early signs of efficacy with relacorilant plus nab-paclitaxel in this patient population, leading to the initiation of a randomized phase 2 trial investigating the combination in this setting. This phase 2 trial included a standard control arm with nab-paclitaxel alone and 2 experimental arms, where relacorilant was administered either intermittently or continuously, Lorusso reports. The data from the intermittent-dosing arm revealed significant improvements in progression-free survival (PFS), overall survival, overall response rate, and duration of response (DOR) with the combination vs nab-paclitaxel monotherapy, as well as a favorable toxicity profile, she explains.

These results provided the foundation for the ongoing, randomized, phase 3 ROSELLA trial (EudraCT 2022-000662-18), she continues, noting that although recruitment for ROSELLA has been completed, the trial is still ongoing, and final results are awaited. This phase 3 trial, which has the potential to be registrational, is comparing nab-paclitaxel alone with nab-paclitaxel combined with intermittent relacorilant in patients with platinum-resistant ovarian cancer. Eligible patients have received no more than 3 prior lines of therapy and have already been treated with bevacizumab (Avastin), Lorusso says. Notably, the phase 2 exploratory analysis indicated that this specific population experienced the greatest benefit from the combination therapy, further justifying the focus of the phase 3 trial, she adds. The final outcomes of ROSELLA will determine whether this combination can be a new therapeutic option for these patients, Lorusso concludes.