Can patients with platinum-resistant ovarian cancer treated with taxane therapy benefit from receiving relacorilant after a taxane? A new subgroup analysis from the phase III ROSELLA trial1 suggests the answer may be yes. The analysis, presented at the 2026 ASCO Annual Meeting, focused on prior taxane use because previous exposure may influence outcomes with subsequent taxane-based regimens; nearly all patients in ROSELLA had previously received a taxane.
Lucy Gilbert, MD, MSc, FRCOG
“The overall survival benefit of relacorilant was seen across all subgroups,” said Lucy Gilbert, MD, MSc, FRCOG, of the Gerald Bronfman Department of Oncology at McGill University, and the McGill University Health Centre (MUHC) and the Research Institute of the MUHC. Prior taxane use, the taxane-free interval, and taxane use in the most recent regimen did not appear to diminish the benefit of adding relacorilant, she reported.
ROSELLA Background
ROSELLA was an open-label phase III trial in patients with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer.2 Patients had an 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 exposure to bevacizumab.
A total of 381 patients were randomly assigned 1:1 to receive relacorilant plus nab-paclitaxel or nab-paclitaxel monotherapy. In the combination arm, patients received nab-paclitaxel at 80 mg/m2 intravenously on days 1, 8, and 15 of each 28-day cycle, with relacorilant at 150 mg orally administered the day before, the day of, and the day after each nab-paclitaxel dose. Patients in the control arm received nab-paclitaxel at 100 mg/m2 on the same schedule.
Dr. Gilbert noted that nab-paclitaxel was selected as the chemotherapy backbone because taxanes are among the most active agents in platinum-resistant ovarian cancer and nab-paclitaxel does not require steroid premedication. This was important because relacorilant is a selective glucocorticoid receptor antagonist.
ROSELLA previously met its dual primary endpoints of progression-free survival and overall survival. At the primary analysis, median progression-free survival was 6.5 months with relacorilant plus nab-paclitaxel vs 5.5 months (hazard ratio [HR] = 0.70).
At the final overall survival analysis, after 288 deaths and a median follow-up of 24.8 months, median overall survival was 16.0 months with the relacorilant combination vs 11.9 months (HR = 0.65), corresponding to a 35% reduction in the risk of death.
Prior Taxane Subgroups
Prior taxane use was nearly universal in ROSELLA, reported in 379 of 381 patients. However, prior taxane exposure did not appear to diminish the overall survival benefit with relacorilant plus nab-paclitaxel.
Among patients with a taxane-free interval of 6 months or less, median overall survival was 16.7 months with relacorilant plus nab-paclitaxel vs 11.0 months with nab-paclitaxel alone (HR = 0.60; 95% confidence interval [CI] = 0.31–1.15). Among those with a taxane-free interval longer than 6 months, median overall survival was 15.7 vs 12.1 months, respectively (HR = 0.66; 95% CI = 0.51–0.86).
KEY POINTS
- A new subgroup analysis from the phase III ROSELLA trial showed overall survival favoring relacorilant plus nab-paclitaxel across prior taxane-use subgroups.
- Overall survival favored the relacorilant combination among patients with taxane-free intervals of 6 months or less and longer than 6 months, as well as among those whose most recent regimen did or did not include a taxane.
- At the final overall survival analysis, the safety profile remained consistent with previous analyses, with no new safety signals identified with longer follow-up.
Overall survival also favored the relacorilant arm regardless of whether a taxane had been used in the most recent regimen. Among patients whose most recent regimen included a taxane, the hazard ratio for overall survival was 0.67 (95% CI = 0.38–1.19). Among those whose most recent regimen did not include a taxane, the hazard ratio was 0.63 (95% CI = 0.48–0.82).
“Whether taxanes were used before, whether it was less than 6 months or more than 6 months, did not reduce the benefit of adding relacorilant,” Dr. Gilbert said.
Safety Profile Remained Consistent
Dr. Gilbert emphasized that benefit must come without significant added toxicity. “It is important that we do not add life with significant toxicity,” she said.
At the final overall survival analysis, the safety profile of relacorilant plus nab-paclitaxel remained consistent with previous analyses, with no new safety signals identified with longer follow-up.
Grade 3 or higher adverse events occurred in 74.5% of patients in the relacorilant arm and 59.5% of those in the nab-paclitaxel arm. Serious adverse events occurred in 35.1% and 23.7%, respectively.
Adverse events leading to discontinuation of nab-paclitaxel were infrequent and similar between the treatment arms (9.6% vs 7.9%). Adverse events leading to discontinuation of relacorilant occurred in 10.1% of patients in the combination arm. No relacorilant-related fatal adverse events occurred, and there were no cases of adrenal insufficiency.
Patients in the relacorilant arm remained on nab-paclitaxel longer. When adjusted for duration of exposure, the incidence rates of neutropenia and anemia were similar between the treatment arms.
Expert Perspective
Discussing the study, Katherine Fuh, MD, PhD, of the University of California, San Francisco, said the ROSELLA subgroup analysis addressed an increasingly relevant question in platinum-resistant ovarian cancer: whether patients can benefit from “taxane after taxane.”
Katherine Fuh, MD, PhD
She noted that the analysis may help clinicians think about taxane sequencing by considering both the taxane-free interval and whether a taxane was used in the most recent regimen.
“When we talk about efficacy, we really need to also focus on side-effect profiles,” Dr. Fuh said. She highlighted that hematologic toxicity was similar between the treatment arms when adjusted for duration of exposure and that peripheral neuropathy occurred at a similar frequency in both arms. She said that more detail on patients whose most recent regimen included a taxane could further clarify how clinicians should sequence treatment.
DISCLOSURE: Dr. Gilbert reported honoraria from AbbVie, GlaxoSmithKline, Merck, and Repare Therapeutics; consulting/advisory roles with Corcept Therapeutics, Eisai, GlaxoSmithKline, ImmunoGen, Kora Healthcare, and Merck; institutional research funding from Alkermes, Ascendis Pharma, AstraZeneca, Bayer, CanariaBio, Corcept Therapeutics, Daiichi Sankyo/AstraZeneca, Eisai, Esperas Pharma, Gilead Sciences, GlaxoSmithKline, GOG Foundation, ImmunoGen, IMV, K-Group Beta, Karyopharm Therapeutics, Merck/MacroGenics, Mersana, Novocure, OncoQuest, Pfizer, Repare Therapeutics, Roche, Seagen, Shattuck Labs, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Sutro BioPharma Inc, and Tesaro; and travel, accommodations, or expenses from Corcept Therapeutics, Eisai, Endomera, GlaxoSmithKline, GOG Foundation, Merck, and Zentalis. Dr. Fuh reported honoraria from AbbVie, AstraZeneca, Corcept Therapeutics, GlaxoSmithKline, Incyclix Bio, Merck, and Natera, as well as patents, royalties, or other intellectual property related to AVB-S6-500.
REFERENCES
1. Gilbert L, You B, et al: Overall survival subgroup analyses for prior taxane use in the phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer. 2026 ASCO Annual Meeting. Abstract 5503. Presented May 29, 2026.
2. Olawaiye AB, Gladieff L, et al: Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA). Lancet 405:2205-2216, 2025.
