Relacorilant Plus Nab-Paclitaxel and Bevacizumab Demonstrates 59% Response Rate in Platinum-Resistant Ovarian Cancer
Clinical Summary:
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Design/Population: Part A of the phase 2 BELLA trial evaluated relacorilant plus nab-paclitaxel and bevacizumab in patients with recurrent platinum-resistant ovarian cancer across approximately 45 international sites.
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Key Outcomes: The triplet demonstrated a median progression-free survival of 7.2 months and an objective response rate of 59%, with more pronounced outcomes among bevacizumab-naïve patients. Median overall survival was not reached, and no new safety signals were identified.
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Clinical Relevance: These findings support further investigation of relacorilant plus nab-paclitaxel and bevacizumab as a potential treatment option for platinum-resistant ovarian cancer, particularly among patients without prior bevacizumab exposure. The single-arm design limits conclusions about comparative efficacy.
Results from Part A of the phase 2 BELLA trial demonstrated encouraging progression-free survival (PFS) and objective response rates (ORR) with relacorilant plus nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer, with more pronounced activity among those without prior bevacizumab exposure.
In this single-arm, open-label trial, 95 patients with recurrent platinum-resistant ovarian cancer received relacorilant in combination with nab-paclitaxel and bevacizumab across approximately 45 clinical sites in North America, Europe, and the Asia-Pacific region.
The analysis evaluated the efficacy and safety of the triplet regimen, with outcomes compared descriptively against historical results from the phase 3 ROSELLA trial evaluating relacorilant plus nab-paclitaxel versus nab-paclitaxel alone.
At analysis, median investigator-assessed PFS was 7.2 months with relacorilant plus nab-paclitaxel and bevacizumab, compared with 5.4 months previously reported with relacorilant plus nab-paclitaxel and 3.9 months with nab-paclitaxel alone in ROSELLA.
The ORR was 59% with the triplet regimen, compared with 37% for relacorilant plus nab-paclitaxel and 30% for nab-paclitaxel monotherapy in ROSELLA.
Median overall survival (OS) had not been reached at the time of the primary analysis. At 6 months, the OS rate was 88% in BELLA, compared with 82% for relacorilant plus nab-paclitaxel and 77% for nab-paclitaxel alone in ROSELLA.
More pronounced activity was observed among patients without prior bevacizumab exposure, who represented approximately half of the BELLA population. In this subgroup, median PFS was 8.1 months, the ORR was 66%, and the 6-month OS rate was 91%.
The safety profile of the triplet regimen was consistent with the known profiles of the individual agents, with no new safety signals identified. The most frequently reported adverse events, occurring in at least 25% of patients, included neutropenia, anemia, nausea, asthenia, nail disorders, peripheral neuropathy, fatigue, and leukopenia.
“Following ROSELLA’s outstanding results, these BELLA data provide valuable insight into adding bevacizumab to the Lifyorli/nab-paclitaxel treatment backbone,” said Domenica Lorusso, MD, PhD, Humanitas Hospital San Pio X, Milan, Italy, and Humanitas University, Rozzano, Italy.
Relacorilant is a selective glucocorticoid receptor antagonist approved in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens, including at least 1 bevacizumab-containing regimen. However, relacorilant is not currently approved for use in combination with bevacizumab.
The investigators reported that the BELLA findings provide additional evidence supporting the clinical activity and manageable safety of relacorilant-based treatment in platinum-resistant ovarian cancer. Complete results from Part A are expected to be presented at a future medical conference.
Source:
Corcept Therapeutics. Corcept reports positive results from phase 2 BELLA trial of lifyorli® combined with nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer. Accessed on: October 30, 2026. https://ir.corcept.com/news-releases/news-release-details/corcept-reports-positive-results-phase-2-bella-trial-lifyorlir
