A marketing authorization application (MAA) for the use of relacorilant in patients with platinum-resistant ovarian cancer has been submitted to the European Medicines Agency, according to an announcement from Corcept Therapeutics Incorporated.1
The submission was supported by findings from the phase 3 ROSELLA study (GOG-3073/ENGOT ov72/APGOT-Ov10/LACOG-0223/ANZGOG-2221/2023; NCT05257408) and phase 2 studies, which showed that when the selective glucocorticoid receptor antagonist was paired with nab-paclitaxel (Abraxane), it improved progression-free survival (PFS) and overall survival (OS) vs nab-paclitaxel alone. Relacorilant was also found to have favorable tolerability, in line with its known toxicity profile.
“Our MAA submission brings us a step closer to our goal of delivering relacorilant to patients with platinum-resistant ovarian cancer,” Joseph Belanoff, MD, chief executive officer of Corcept Therapeutics, stated in a news release. “Better treatment options are urgently needed. Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated.”
Status of Relacorilant in Platinum-Resistant Ovarian Cancer: Top Takeaways
- Corcept Therapeutics has submitted a marketing authorization application to the EMA for relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer, following positive phase 3 ROSELLA and other phase 2 data.
- In ROSELLA, the combination improved median PFS to 6.54 months vs 5.52 months and OS to 15.97 months vs 11.50 months.
- Relacorilant showed a manageable safety profile, requires no biomarker testing, and is an oral agent that could be easily integrated into current treatment practice.
- A new drug application for relacorilant in this patient population is also under FDA review.
What Was the ROSELLA Study Schema?
The phase 3 trial enrolled patients (n = 381) with epithelial ovarian, primary peritoneal or fallopian tube cancer who experienced progression within 6 months after their last dose of platinum therapy.2 Patients had an ECOG performance status of 0 or 1, had previously received 1 to 3 lines of therapy, and had prior exposure to bevacizumab (Avastin).
Participants were randomized 1:1 to receive 150 mg of relacorilant plus 80 mg/m2 of nab-paclitaxel or 100 mg/m2 (n = 188) of nab-paclitaxel alone (n = 193). Treatment continued until disease progression or intolerable toxicity. Stratification factors included prior lines of therapy (1 vs >1) and region (North America vs Europe vs Korea, Australia, and Latin America).
The dual primary end points of the study were PFS by blinded independent central review and RECIST 1.1 criteria and OS. Secondary end points included investigator-assessed PFS, objective response rate (ORR), duration of response, clinical benefit rate (CBR), response by CA-125 Gynecologic Cancer Intergroup (GCIG) criteria, combined response by GCIG and RECIST criteria, and safety.
The median patient age was 61 years (range, 26-85) in the relacorilant arm and 62 years (range, 33-86) in the nab-paclitaxel–alone arm. Most patients were White (72.3% vs 69.9%), and slightly more than half were from Europe (56.9% vs 56.5%). About one-third had an ECOG performance status of 1 or 2 (28.2% vs 32.6%), and around 12% had BRCA1/2 mutations (12.2% vs 12.4%). In the experimental arm, 8.0%, 48.9%, and 43.1% of patients received 1, 2, or 3 prior lines of therapy, respectively; in the control arm, these respective rates were 9.3%, 46.1%, and 44.6%. In the experimental arm, 6.9% of patients were primary platinum refractory, 35.6% had received at least 1 prior line of therapy in the platinum-resistant setting, and 4.3% had prior taxane exposure in the platinum-resistant setting; in the control arm, these rates were 6.7%, 42.5%, and 3.6%. Prior therapies received in the combination and monotherapy arms were bevacizumab (100%; 100%), taxanes (99.5%; 99.5%), pegylated liposomal doxorubicin (64.4%; 64.8%), and PARP inhibition (60.6%; 62.2%).
