KEY TAKEAWAYS
- The phase III trial aimed to validate the efficacy of relacorilant in combination with nab-paclitaxel in a larger patient population with platinum-resistant OC.
- The primary endpoint is PFS. Secondary endpoints were OS and PFS.
- The study showed enhanced PFSl and OS in platinum-resistant OC pts treated with relacorilant plus nab-paclitaxel compared to nab-paclitaxel alone.
Ovarian cancer(OC) patients(pts) with platinum resistance often have poor outcomes with single-agent chemotherapy. Relacorilant, a selective glucocorticoid receptor modulator, has shown promise in improving chemotherapy efficacy in these pts.
Researchers aimed to validate the efficacy of relacorilant in combination with nab-paclitaxel in a larger patient population with platinum-resistant OC.
The study included women with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer, having undergone 1–3 lines of prior systemic anticancer therapy (including bevacizumab) and at least 1 line of platinum-based therapy.
Patients with primary platinum-refractory disease are excluded. Approximately 360 pts are randomized 1:1 to receive relacorilant (150 mg the day before, of, and after nab-paclitaxel infusion) + nab-paclitaxel (80 mg/m2) or nab-paclitaxel monotherapy (100 mg/m2). Nab-paclitaxel is administered on days 1, 8, and 15 of each 28-day cycle. Stratification factors include prior lines of therapy (1 vs >1) and region of the world (North America vs. Europe vs. rest of world).
The study showed enhanced PFSl and OS in platinum-resistant OC pts treated with relacorilant plus nab-paclitaxel compared to nab-paclitaxel alone.
Source: https://www.emma.events/site/programme/?sessiondetail=4534566&trackid=0&a=esgo2023#!
Clinical Trial: https://clinicaltrials.gov/study/NCT05257408
Lorusso D, Bagameri A, Bishop E, Chudecka-Glaz A, Devaux A, Gladieff L, Gordinier ME, Kim JW, Korach J, McCollum ME, Mileshkin L, Monk BJ, Nicum S, Nogueira-Rodrigues A, Oaknin A, O’Malley D, Orlando M, Dreiling L, Tudor IC, Olawaiye AB; ROSELLA Study Group. ROSELLA (GOG-3073, ENGOT-Ov72/MITO): A Phase 3 Study Of Relacorilant + Nab-Paclitaxel Vs. Nab-Paclitaxel In Advanced, Platinum-Resistant Ovarian Cancer.
