ROSELLA – GOG-3073 – ENGOT-OV72/MITO: A phase 3 study of relacorilant + nab-paclitaxel vs. nab-paclitaxel in advanced, platinum-resistant ovarian cancer (1241)

Platinum resistance occurs in virtually all patients with recurrent ovarian cancer. Single-agent chemotherapies are commonly used in this setting, but outcomes are generally poor, leaving a large unmet need for novel, targeted treatments. Cortisol, which acts by binding to the glucocorticoid receptor (GR), can reduce the efficacy of chemotherapies by suppressing the apoptotic pathways used by cytotoxic agents. The GR is abundantly expressed in ovarian tumors, and high GR expression is associated with poor outcomes. Preclinical and clinical data indicate that modulation of GR signaling with relacorilant, a selective GR modulator, can reverse the antiapoptotic effects of cortisol, thereby enhancing chemotherapy efficacy. In a phase II study in patients with recurrent, platinum-refractory or platinum-resistant ovarian cancer, intermittently dosed relacorilant + nab-paclitaxel showed clinically meaningful improvement in progression-free survival (PFS), duration of response, and a trend towards improved overall survival (OS) without increased side effect burden compared to nab-paclitaxel monotherapy. This phase III study aims to confirm the findings of the phase II study in a larger patient population.