Final Overall Survival Data From a Randomized, Open-Label, Phase 2 Study of Relacorilant, a Selective Glucocorticoid Receptor Modulator, in Combination With Nab-Paclitaxel in Patients With Recurrent Platinum-Resistant Ovarian Cancer
Summary & Conclusions
- There is a high unmet need for novel therapies for patients with advanced, platinum-resistant ovarian cancer
- The selective glucocorticoid receptor modulator (SGRM) relacorilant has shown potential in restoring chemosensitivity and enhancing chemotherapy efficacy
- With an additional ~16 months of follow-up, the findings from the primary OS analysis of this randomized, open-label, phase 2 study were confirmed
- After a median follow-up of 38 months, intermittent relacorilant + nab-paclitaxel had improved OS compared to nab‑paclitaxel monotherapy (HR: 0.69 [95% CI: 0.46—1.02])
- In the overall population, the chance of survival at 24 months was doubled for patients receiving relacorilant + nab-paclitaxel vs nab-paclitaxel monotherapy, and the frequency and nature of AEs were similar across study arms
- This trend continued at 36 months
- In the subgroup of patients with 1—3 prior therapies, including prior bevacizumab, without primary platinum-refractory disease, median OS was prolonged by 5 months in the intermittent relacorilant + nab-paclitaxel arm (17.9 months) vs nab-paclitaxel monotherapy (12.6 months)
- These promising results have paved the way for the currently enrolling phase 3 ROSELLA trial