Relacorilant Plus Nab-Paclitaxel and Bevacizumab Yields Clinically Meaningful in Platinum-Resistant Ovarian Cancer

Relacorilant (Lifyorli) given in combination with nab-paclitaxel (Abraxane) and bevacizumab (Avastin) generated clinically meaningful activity n patients with recurrent, platinum-resistant ovarian cancer, according to topline results from Part A of the phase 2 BELLA trial (NCT06906341).¹

Findings announced by Corcept Therapeutics showed that evaluable patients (n = 95) experienced a median investigator-assessed progression-free survival (PFS) of 7.2 months and an objective response rate (ORR) of 59%. Median overall survival (OS) had not been reached at the time of the primary analysis, and 88% of patients were alive at 6 months. Approximately half of the 95 patients enrolled in Part A had not previously received bevacizumab, and responses were more pronounced in this bevacizumab-naive subgroup (66%), which experienced a median PFS of 8.1 months and a 6-month OS rate of 91%.

Corcept Therapeutics placed these findings alongside data from the phase 3 ROSELLA trial (NCT05257408), in which relacorilant plus nab-paclitaxel and nab-paclitaxel alone yielded median PFS of 5.4 months and 3.9 months, ORRs of 37% and 30%, and 6-month OS rates of 82% and 77%, respectively. Data from ROSELLA supported the March 2026 FDA approval of relacorilant plus nab-paclitaxel for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 systemic treatment regimens, at least 1 of which included bevacizumab.²

Safety findings from BELLA were consistent with the known profiles of each agent in the combination, with no new safety signals identified.¹ The most common adverse effects occurring in at least 25% of patients comprised neutropenia, anemia, nausea, asthenia, nail disorder, peripheral neuropathy, fatigue, and leukopenia.

Complete results from BELLA Part A will be presented at a medical conference in 2027.

"Following ROSELLA's outstanding results, these BELLA data provide valuable insight into adding bevacizumab to the Lifyorli/nab-paclitaxel treatment backbone," Domenica Lorusso, MD, PhD, director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X in Milan, Italy, and full professor of obstetrics and gynaecology at Humanitas University in Rozzano, stated in a news release. "These findings help advance our understanding of both the efficacy and safety profile of this triplet combination as we work to expand treatment options for patients."

Beyond its current FDA approval, in September 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of relacorilant plus nab-paclitaxel for adult patients with platinum-resistant ovarian cancer, based on data from ROSELLA and an earlier phase 2 trial (NCT03776812).³

How was the BELLA trial designed?

The ongoing BELLA trial is an open-label, global, multi-arm, phase 2 study evaluating relacorilant in combination with other treatments in patients with gynecologic cancers, with independent, parallel arms and an overall target enrollment of 270 patients.⁴ Part A was a single-arm cohort that enrolled 95 women with recurrent, platinum-resistant ovarian cancer at approximately 45 sites in North America, Europe, and the Asia-Pacific region.^1,4

Patients in the platinum-resistant cohort were required to have histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma; 1 to 3 prior lines of systemic anticancer therapy; an ECOG performance status of 0 or 1; a life expectancy of at least 3 months; and adequate organ function.⁴

Key exclusion criteria included progression during weekly paclitaxel or nab-paclitaxel, conditions requiring chronic or frequent corticosteroid treatment, peripheral neuropathy greater than grade 1, and bowel obstruction within 12 weeks of study entry.

Patients received oral relacorilant at 150 mg once daily with food on the day before, the day of, and the day after each nab-paclitaxel infusion. Nab-paclitaxel was given at 80 mg/m² intravenously on days 1, 8, and 15, and bevacizumab was administered at 10 mg/kg intravenously on days 1 and 15 of each 28-day cycle.

The primary end point is investigator-assessed PFS per RECIST 1.1 criteria. Secondary end points include ORR, best overall response, duration of response, clinical benefit rate at week 24, OS probability at 6, 12, and 18 months, and safety.

References

1. Corcept reports positive results from phase 2 BELLA trial of Lifyorli combined with nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics. October 26, 2026. Accessed October 28, 2026. https://ir.corcept.com/news-releases/news-release-details/corcept-reports-positive-results-phase-2-bella-trial-lifyorlir
2. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. FDA. March 25, 2026. Accessed March 25, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
3. Corcept announces CHMP opinion recommending EU marketing authorization for Lifyorli (relacorilant). News release. Corcept Therapeutics. September 18, 2026. Accessed October 28, 2026. https://ir.corcept.com/news-releases/news-release-details/corcept-announces-chmp-opinion-recommending-eu-marketing
4. Relacorilant in combination with different treatment regimens in patients with gynecological cancers. ClinicalTrials.gov. Updated July 16, 2026. Accessed October 28, 2026. https://clinicaltrials.gov/study/NCT06906341