Relacorilant/Nab-Paclitaxel Reduces Risk of Death by 35% in Platinum-Resistant Ovarian Cancer

Treatment with relacorilant (Lifyorli) plus nab-paclitaxel (Abraxane) led to a 35% reduction in the risk of death compared with nab-paclitaxel monotherapy in platinum-resistant ovarian cancer. These statistically significant overall survival (OS) results from the phase 3 ROSELLA study (NCT05257408) were shared at the 2026 Society of Gynecologic Oncology Annual Meeting on Women’s Health (SGO).¹

The median OS with relacorilant plus nab-paclitaxel (n = 188) was 16.0 months (95% CI, 13.0-18.3) vs 11.9 months (95% CI, 10.0-13.8) with nab-paclitaxel monotherapy (n = 193; HR, 0.65; 95% CI, 0.51-0.83; 2-sided stratified log-rank P = .0004). The 12-month OS rates in the respective arms were 60% and 50%, and the 18-month OS rates were 46% and 27%, respectively.

Moreover, OS data favored the relacorilant combination across all prespecified subgroups, including prior lines of therapy (2: HR, 0.68; 95% CI, 0.48-0.96; 3: HR, 0.60; 95% CI, 0.41-0.86), prior PARP exposure (yes: HR, 0.70; 95% CI, 0.51-0.95; no: HR, 0.67; 95% CI, 0.46-0.98), and primary platinum-free interval length (≤ 6 months: HR, 0.61; 95% CI, 0.39-0.96; > 6 months: HR, 0.68; 95% CI, 0.51-0.91).

“We are very delighted to present this regimen now as an option for treatment of patients with platinum-resistant ovarian cancer,” Alexander B. Olawaiye, MD, said in a presentation of the data. “It is now listed as a preferred option in the NCCN guidelines.” Olawaiye is the vice chair for DEI and a professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences, as well as a director of gynecologic cancer research at Magee-Women’s Hospital of the University of Pittsburgh Medical Center in Pennsylvania.

What was the study schema of ROSELLA?

The study enrolled patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer who had an ECOG performance status of 0 or 1, and experienced disease progression in under 6 months after the last dose of platinum therapy. Patients had prior exposure to bevacizumab (Avastin) and previously received 1 to 3 lines of therapy.

After undergoing screening (n = 381), patients were randomized 1:1 to receive relacorilant at 150 mg plus nab-paclitaxel at 80 mg/m² or nab-paclitaxel alone at 100 mg/m². Treatment continued until progressive disease or unacceptable toxicity. Key stratification factors were prior lines of therapy (1 vs >1) and region (North America vs Europe vs Korea, Australia, and Latin America).

The trial’s dual primary end points were progression-free survival (PFS) by RECIST 1.1 and blinded independent central review and OS. Secondary end points comprised PFS by RECIST 1.1 and investigator assessment; objective response rate, duration of response, and clinical benefit rate by RECIST 1.1; response per CA-125 Gynecologic Cancer Intergroup (GCIG) criteria; combined response by RECIST and CA-125 GCIG criteria; and safety.

What were the baseline characteristics of the patients enrolled to ROSELLA?

The median patient age was 61 years (range, 26-85) in the relacorilant arm vs 62 years (range, 33-86) in the nab-paclitaxel arm. Most patients across the arms were White (72.3%; 69.9%) and from Europe (56.9%; 56.5%). About one-third of patients had an ECOG performance status of 1 or 2 (28.2%; 32.6%) and about 12% had BRCA1/2 mutations (12.2%; 12.4%).

In the relacorilant arm, 8.0% of patients received 1 prior line of therapy, 48.9% received 2 prior lines, and 43.1% received 3 prior lines; in the nab-paclitaxel–alone arm, these respective rates were 9.3%, 46.1%, and 44.6%. Almost 7% of patients were primary platinum refractory (6.9%; 6.7%). Moreover, 35.6% of patients in the relacorilant arm received 1 or more prior lines of therapy in the platinum-resistant setting, vs 42.5% of those in the nab-paclitaxel monotherapy arm. Additionally, 4.3% of patients in the relacorilant arm and 3.6% of patients in the nab-paclitaxel–alone arm received a prior taxane in the platinum-resistant setting. Prior therapies beyond bevacizumab in the respective arms included taxanes (99.5%; 99.5%), pegylated liposomal doxorubicin (64.4%; 64.8%), and PARP inhibitor (60.6%; 62.2%).

What ROSELLA data have been previously reported?

Findings from the primary analysis of the study, which had a data cutoff date of February 24, 2025, showed that the median PFS was 6.5 months (95% CI, 5.6-7.4) in the relacorilant/nab-paclitaxel arm vs 5.5 months (95% CI, 3.9-5.9) in the nab-paclitaxel monotherapy arm (HR, 0.70; 95% CI, 0.54-0.91; P = .0076).² The 6-month PFS rates in the respective arms were 52% and 42%; the PFS rates at 12 months were 25% and 13%.¹

The data supported the March 2026 FDA approval of relacorilant plus nab-paclitaxel in 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.³ Olawaiye noted at the beginning of the presentation that it may include data that are not included in the approved Prescribing Information for relacorilant.¹

What was learned about subsequent therapies?

“We dug into subsequent therapies received by the patients after leaving the trial and they were very balanced across the two arms,” Olawaiye said.

Specifically, 67.6% of patients in the relacorilant arm received subsequent systemic anticancer therapies vs 72.0% of those in the nab-paclitaxel monotherapy arm. Subsequent therapies included gemcitabine (35.1%; 32.1%), pegylated liposomal doxorubicin (23.4%; 20.7%), investigational antineoplastic drugs (14.4%; 15.0%), carboplatin (14.9%; 13.0%), cyclophosphamide (13.8%; 11.9%), topotecan (9.6%; 13.0%), paclitaxel (9.6%; 10.9%), bevacizumab (9.0%; 6.2%), cisplatin (8.0%; 4.1%), and mirvetuximab soravtansine-gynx (Elahere; 6.4%; 5.7%).

What was revealed about the safety profile of relacorilant plus paclitaxel?

All patients in the relacorilant/nab-paclitaxel arm (n = 188) experienced adverse effects (AEs) vs 99.5% of those in the nab-paclitaxel arm (n = 190); these effects were grade 3 or higher in 74.5% and 59.5% of patients, respectively. Serious AEs occurred in 35.1% of those in the relacorilant arm vs 23.7% of those in the nab-paclitaxel monotherapy arm. In the relacorilant arm, 10.1% of patients experienced AEs that led to discontinuation of relacorilant and 9.6% had AEs that led to nab-paclitaxel discontinuation; in the nab-paclitaxel monotherapy arm, 7.9% of patients experienced AEs that led to discontinuation (HR, 1.00; 95% CI, 0.50-2.00; P = .998).

Olawaiye noted that there were no fatal AEs associated with relacorilant, and no cases of adrenal insufficiency were reported. “At the final OS analysis, the safety profile was consistent with that at the time of the primary analysis,” he added. No new signals were reported with extended follow-up.

The most common grade 3 or higher AEs reported in the combination and monotherapy arms were neutropenia (44% vs 25%), anemia (18% vs 9%), nausea (4% vs 3%), diarrhea (4% vs 2%), constipation (1% vs 0%), abdominal pain (2% vs 1%), vomiting (3% vs 2%), decreased appetite (2% vs 1%), fatigue (9% vs 2%), and alopecia (1% vs 0%).

“When adjusted for duration of exposure, the incidence rates of neutropenia and anemia were similar between study arms,” Olawaiye concluded. “Peripheral neuropathy occurred with similar frequency in both arms, [at 19.1% and 17.4%].” There were five serious cases of febrile neutropenia (2.1% vs 0.5%), and five serious cases of sepsis (1.6% vs 1.1%).

Disclosures: Dr Olawaiye disclosed financial relationships with the following ACCME defined ineligible companies: AstraZeneca, Foundation Medicine, GSK, Merck, Daiichi Sankyo, Eisai, Corcept, and Eli Lilly.

References

1. Olawaiye AB, Quesada S, Gilbert L, et al. Final overall survival results from the phase 3 ROSELLA trial: relacorilant plus nab-paclitaxel vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer. Presented at: 2026 SGO Annual Meeting; April 10-13, 2026; San Juan, Puerto Rico.
2. Olawaiye A, Gladieff L, Gilbert L, et al. ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). J Clin Oncol. 2025;43(suppl 17):LBA5507. doi:10.1200/JCO.2025.43.17_suppl.LBA5507
3. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. FDA. March 25, 2026. Accessed April 10, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or