Final overall survival results from the phase III ROSELLA trial showed a statistically and clinically significant survival benefit with the selective glucocorticoid receptor antagonist relacorilant plus nab-paclitaxel vs nab-paclitaxel alone in patients with platinum-resistant ovarian cancer. Median overall survival was 16.0 months with the combination compared with 11.9 months with nab-paclitaxel monotherapy, yielding a hazard ratio (HR) of 0.65 and a 35% reduction in the risk of death.

Alexander B. Olawaiye, MD

ROSELLA built on earlier phase I/II and randomized phase II studies of relacorilant plus nab-paclitaxel that supported further development of the regimen. Referring to those earlier data, Alexander B. Olawaiye, MD, of the University of Pittsburgh School of Medicine, said they “gave birth to ROSELLA” and “call for celebration on behalf of our patients” because the regimen is now a U.S. Food and Drug Administration (FDA)-approved option for platinum-resistant ovarian cancer.

Dr. Olawaiye presented the findings at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, which were also recently published in The Lancet.^1,2

During his presentation, he noted that “platinum-resistant ovarian cancer is very difficult to treat, with a short median overall survival,” and emphasized the need for new options. He explained that because the glucocorticoid receptor—associated with poor prognosis and potential chemotherapy resistance—is expressed in ovarian cancer, relacorilant may help restore sensitivity to cytotoxic therapy. This made it a rational partner for nab-paclitaxel, one of the more active agents in platinum-resistant ovarian cancer and one that does not require steroid pretreatment.

Study Design

ROSELLA randomly assigned 381 patients in a 1:1 ratio to relacorilant plus nab-paclitaxel or nab-paclitaxel alone. Patients in the experimental arm received 150 mg of oral relacorilant on the day before, the day of, and the day after treatment with 80 mg/m² of nab-paclitaxel, which was administered on days 1, 8, and 15 of each 28-day cycle. The control arm was treated with 100 mg/m² of nab-paclitaxel on the same schedule. Treatment continued until disease progression or unmanageable toxicity.

Eligible patients had epithelial ovarian, primary peritoneal, or fallopian tube cancer; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; disease progression within 6 months of the last platinum dose; one to three prior lines of therapy; and prior bevacizumab exposure. The dual primary endpoints were progression-free survival by blinded independent central review and overall survival.

Baseline characteristics appeared to be well balanced between treatment arms. Median age was 61 to 62 years; nearly all patients had prior bevacizumab and taxane exposure, about 60% had received a PARP inhibitor, and roughly 43% of each arm had undergone three prior lines of therapy. Most tumors were high-grade serous carcinomas.

Survival Outcomes Improved

The trial previously met its progression-free survival endpoint.³ At the primary analysis, median progression-free survival was 6.5 months with relacorilant plus nab-paclitaxel vs 5.5 months with nab-paclitaxel alone (HR = 0.70; P = .0076). The 6-month progression-free survival rates were 52% and 42%, respectively. Dr. Olawaiye noted that the percentage of patients without disease progression at 12 months was nearly double in the relacorilant arm compared with the control arm, at 25% vs 13%.

At the final overall survival analysis, conducted at a median follow-up of 24.8 months and 76% maturity, 129 deaths had occurred in the relacorilant arm and 159 in the control arm. Median overall survival was 16.0 months with relacorilant plus nab-paclitaxel vs 11.9 months with nab-paclitaxel alone (HR = 0.65; P = .0004).

Dr. Olawaiye said the overall survival curves separated early and continued to widen. He also reported that the proportion of patients alive at 18 months was nearly double with the combination compared with nab-paclitaxel alone.

Benefit Seen Across Subgroups

Overall survival was found to favor the relacorilant arm across key prespecified subgroups. HRs remained below 1.0 across those defined by age, region, ECOG performance status, number of prior lines of therapy, prior PARP inhibitor use, primary platinum-free interval, BRCA status, and largest target lesion size.

Dr. Olawaiye emphasized that benefit was also seen in subgroups with high unmet need, including patients who were more heavily pretreated, had prior PARP inhibitor exposure, or had shorter platinum intervals.

To address whether poststudy treatment differences might account for the survival advantage, the investigators examined subsequent therapies and found them to be well balanced between the arms. About two-thirds to just over 70% of patients in each arm received subsequent systemic anticancer therapy, and the types of therapies received appeared generally similar.

Safety and Tolerability

The regimen seemed to be well tolerated, with a favorable and consistent safety profile. In the safety population, which included patients who received at least one dose of study drug, any-grade adverse events were reported in nearly all patients. Grade 3 or higher adverse events were documented in 74.5% of the relacorilant arm and 59.5% of the control arm; serious adverse events occurred in 35.1% and 23.7%, respectively.

Adverse events leading to nab-paclitaxel discontinuation were infrequent and appeared to occur at similar rates between the arms. There were no relacorilant-related fatal adverse events and no cases of adrenal insufficiency. No new safety signals were reported with longer follow-up.

The most common adverse events were neutropenia, anemia, fatigue, nausea, and peripheral neuropathy. When adjusted for duration of exposure, the rates of neutropenia and anemia were similar between the study arms; peripheral neuropathy occurred at comparable frequency.

Putting the Findings in Context

In her discussion of the session, Roisin E. O’Cearbhaill, MD, of Memorial Sloan Kettering Cancer Center, described ROSELLA as a biologically rational study, noting that glucocorticoid receptor antagonism offers a plausible strategy to overcome taxane resistance in platinum-resistant ovarian cancer. She also placed the trial in a broader context, arguing that although new approvals such as relacorilant plus nab-paclitaxel represent real progress, unmet need remains high, and treatment sequencing is becoming more complicated as more active options move into the clinic.

Roisin E. O’Cearbhaill, MD

More broadly, Dr. O’Cearbhaill characterized the survival gains seen with platinum-resistant ovarian cancer combinations as incremental and emphasized that clinicians will need to pay close attention to magnitude of benefit, toxicity, and patient selection as the treatment landscape continues to expand.

A New Option in Platinum-Resistant Disease

ROSELLA met both dual primary endpoints of progression-free and overall survival. The investigators stated that the 4.1-month median overall survival improvement with relacorilant plus nab-paclitaxel vs nab-paclitaxel alone positions the combination as a new treatment option for patients with platinum-resistant ovarian cancer without the need for biomarker selection.

Dr. Olawaiye said that in addition to receiving FDA approval, relacorilant plus nab-paclitaxel is now listed as a preferred option in the National Comprehensive Cancer Network (NCCN) Guidelines. 

DISCLOSURE: Dr. Olawaiye reported financial relationships with AstraZeneca, Foundation Medicine, GSK, Merck, Daiichi Sankyo, Eisai, Corcept, and Eli Lilly. Dr. O’Cearbhaill has held advisory roles with AstraZeneca, AbbVie, Cardinal Health, Corcept, GSK, Genmab/Pfizer, Loxo, Regeneron, Takeda, and Tubulis.

REFERENCES

1. Olawaiye A, et al: Relacorilant plus nab-paclitaxel vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (PROC) (GOG-3073, ENGOT-ov72, APGOT-Ov10, and LACOG-0223). 2026 SGO Annual Meeting. Abstract LBA01. Presented April 10, 2026.

2. Lorusso D, et al: Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA). Lancet 407:1513-1524, 2026.

3. Olawaiye AB, et al: Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA). Lancet 405:2205-2216, 2025.