Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial.

# Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial *The Lancet 2026* Articles Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial Domenica Lorusso, Laurence Gladieff, David M O’Malley, Jae-Weon Kim, Gabriel Garbaos, Anna Fagotti, Lucy Gilbert, Linda Mileshkin, Stanislas Quesada, Elizabeth Hopp, Yong Jae Lee, Ana Oaknin, Mariana Scaranti, Byoung-Gie Kim, Andrew Clamp, Christina Prillaman, Connie Diakos, Andrea Bagaméri, Aliza L Leiser, Vanda Salutari, Bradley J Monk, Philippe Follana, Emily McClung, Vittoria Carbone, Brian Slomovitz, Elena Giudice, Maria Chiara Cannizzaro, Laurène Gavoille, Alix Devaux, Paolo Scollo, Giuseppa Scandurra, Chiara Cassani, Grazia Artioli, Toon Van Gorp, Ana Santaballa, Lyndah K Dreiling, Amanda Kesner-Hays, Iulia Cristina Tudor, Adrian M Jubb, Nicoletta Colombo, Alexander B Olawaiye Summary Background Relacorilant is a selective glucocorticoid receptor antagonist that increases the sensitivity of many cancer Lancet 2026; 407: 1513–24 cell types to chemotherapy. The efficacy and safety of relacorilant plus nab-paclitaxel were assessed in the phase 3 Published Online ROSELLA (GOG-3073, ENGOT-ov72, APGOT-Ov10, and LACOG-0223) trial; the combination showed significant April 10, 2026 improvement in progression-free survival among patients with platinum-resistant ovarian cancer compared with nab- https://doi.org/10.1016/ S0140-6736(26)00462-9 paclitaxel monotherapy. Results of the final overall survival analysis are reported here. Department of Biomedical Science, Humanitas University, Methods In this open-label phase 3 trial, patients were randomly assigned 1:1 to receive relacorilant (150 mg orally the Pieve Emanuele, Italy day before, day of, and day after nab-paclitaxel infusion) plus nab-paclitaxel (80 mg/m² intravenously on days 1, 8, (Prof D Lorusso MD); Humanitas and 15 of each 28-day cycle) or nab-paclitaxel monotherapy (100 mg/m² intravenously on the aforementioned schedule). San Pio X Hospital, Milan, Italy (Prof D Lorusso); Oncopole Patients, aged 18 years or older, with one to three lines of previous anticancer therapy and platinum-resistant disease Claudius Regaud IUCT- (progression <6 months from their last dose of platinum) were eligible. The trial was conducted at 117 hospitals and Oncopole, Toulouse, France community oncology centres in 14 countries across Australia, Europe, Latin America, North America, and South Korea. (L Gladieff MD); GINECO, Paris, Progression-free survival, assessed by blinded independent central review, and overall survival (time from France (L Gladieff, S Quesada MD, P Follana MD); randomisation to death from any cause) were dual primary endpoints. Additional prespecified endpoints included James Comprehensive Cancer safety, second progression-free survival (time from randomisation to disease progression on subsequent anticancer Center, The Ohio State therapy or death due to any cause, whichever occurred first), and patient-reported outcomes. This trial is registered at University, Columbus, OH, USA ClinicalTrials.gov, NCT05257408, and is ongoing. (D M O’Malley MD); Department of Obstetrics and Gynecology, Seoul National University Findings Between Jan 5, 2023, and April 8, 2024, 381 patients were randomly assigned to the relacorilant combination College of Medicine, Seoul, group (n=188) or the nab-paclitaxel monotherapy group (n=193). All patients had received bevacizumab; 167 (44%) had South Korea (Prof J-W Kim MD); received three previous lines of therapy, and 234 (61%) had received a poly(ADP-ribose) polymerase inhibitor. At a Instituto Médico de la Fundación Estudios Clínicos, median follow-up of 24∙8 months (95% CI 23∙6–25∙7), the addition of relacorilant to nab-paclitaxel resulted in a Santa Fe, Argentina statistically and clinically significant improvement in overall survival compared with nab-paclitaxel monotherapy (G Garbaos MD); Gynecologic (hazard ratio for death 0∙65 [95% CI 0∙51–0∙83]; p=0∙0004); 18-month overall survival was 46% and 27%, respectively. Oncology Unit, Fondazione The median overall survival in the relacorilant combination group was extended by 4∙1 months compared with the Policlinico Universitario A Gemelli, IRCCS, Rome, Italy nab-paclitaxel monotherapy group (16∙0 [95% CI 13∙0–18∙3] vs 11∙9 months [10∙0–13∙8]). Subsequent anticancer (Prof A Fagotti MD); Division of treatments were similar across study groups. Adverse events were similar in both groups when adjusted for duration Gynecologic Oncology, of study treatment. Neutropenia (121 [64%]), anaemia (115 [61%]), fatigue (101 [54%]), and nausea (82 [44%]) were the Research Institute, McGill most common adverse events in the relacorilant combination group. No new safety signals were observed with University Health Centre, Gerald Bronfman Department additional follow-up since the primary analysis. of Oncology, McGill University, Montreal, QC, Canada Interpretation The addition of relacorilant to nab-paclitaxel led to significantly longer overall survival in patients with (L Gilbert MD); Department of Medical Oncology, Peter platinum-resistant ovarian cancer, without the need for biomarker selection. The findings support relacorilant plus MacCallum Cancer Centre, nab-paclitaxel as a potential new standard treatment option for patients with platinum-resistant ovarian cancer. Melbourne, VIC, Australia (L Mileshkin MBBS); Montpellier Funding Corcept Therapeutics. Cancer Institute, Montpellier, France (S Quesada); Department of Obstetrics and Copyright © 2026 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 Gynecology, Medical College of license. Wisconsin, Milwaukee, WI, USA (E Hopp MD); Yonsei University Introduction median overall survival estimates in clinical trials range College of Medicine, Seoul, South Korea (Prof Y J Lee MD); Platinum-resistant ovarian cancer is a leading cause of from 10 months to 17 months.3–5 Treatment options in this Medical Oncology Department, gynaecological cancer-related mortality worldwide;1,2 setting are limited to single-agent chemotherapy with or Hospital Universitario Puerta Articles de Hierro-Majadahonda, Madrid, Spain Research in context (Prof A Oaknin MD); Rede Américas Oncologia, Hospital 9 Evidence before this study statistical analysis plan, and is based on a complete dataset. In de Julho, São Paulo, Brazil In a search of PubMed for articles published up to Jan 27, 2026, addition, positive data for second progression-free survival (M Scaranti MD); Samsung using the search terms “selective” AND “glucocorticoid confirm that the treatment benefit of relacorilant provides Medical Center, Sungkyunkwan receptor” AND (“cancer” or “carcinoma”) with no language durable disease control beyond first progression. The study also University School of Medicine, Seoul, South Korea restrictions, we found that data have been published on provides patient-reported outcome data and updated safety (Prof B-G Kim MD); The Christie selective glucocorticoid receptor antagonism in ovarian cancer data to support a complete benefit–risk determination. NHS Foundation Trust, for only four clinical trials, three with the selective Manchester, UK Implications of all the available evidence glucocorticoid receptor antagonist relacorilant and one with (A Clamp BMBCh); University of Combined with the evidence from previous studies, these Manchester, Manchester, UK the less selective ORIC-101. The first trial (NCT02762981) was a positive overall survival data support relacorilant plus nab- (A Clamp); Virginia Oncology phase 1/2 study to determine the recommended phase 2 dose Associates, Norfolk, VA, USA of relacorilant plus nab-paclitaxel in patients with advanced paclitaxel as a potential new standard treatment option for (C Prillaman MD); Royal North patients with platinum-resistant ovarian cancer, without the solid tumours. The second and third trials (NCT03776812 and Shore Hospital, St Leonards, need for biomarker selection. This study is the first positive NSW, Australia NCT05257408) were a randomised phase 2 study, and the clinical trial conducted with registrational intent for a selective (C Diakos MBBS); Department primary results of the phase 3 study described herein, of Gynecology, Hungarian glucocorticoid receptor antagonist in patients with cancer. The evaluating the combination of relacorilant plus nab-paclitaxel National Institute of Oncology, data supports the ongoing evaluation of relacorilant in other in patients with platinum-resistant ovarian cancer. The fourth Budapest, Hungary solid tumour indications and in combination with other classes (A Bagaméri MD); Rutgers trial (NCT03928314) was a phase 1 dose escalation and of anticancer agents. In the AURELIA trial, the VEGF inhibitor Cancer Institute of New Jersey, expansion study to determine the recommended phase 2 dose New Brunswick, NJ, USA bevacizumab also extends progression-free survival in of ORIC-101 in combination with nab-paclitaxel in patients (A L Leiser MD); Department of combination with chemotherapy in this setting but has not with advanced solid tumours. Woman, Child, and Public shown a statistically significant overall survival benefit— Health, Fondazione Policlinico Added value of this study probably owing, in part, to crossover to the investigational Universitario Agostino Gemelli, Rome, Italy (V Salutari MD); The positive results for final overall survival, a dual primary group at progression—and is predominantly used in earlier lines Florida Cancer Specialists and endpoint of the ROSELLA (GOG-3073, ENGOT-ov72, APGOT- of therapy for patients with ovarian cancer. Furthermore, Research Institute, West Palm Ov10, and LACOG-0223) study, confirm the previously reported mirvetuximab soravtansine has shown an overall survival Beach, FL, USA data for the other dual primary endpoint, progression-free benefit in a third of patients with high-grade serous folate (Prof B J Monk MD); Centre Antoine Lacassagne, Nice, survival, and are consistent with the findings from the phase 2 receptor α–positive ovarian cancer. The addition of France (P Follana); Stanford study. In a patient population that is receiving single-agent pembrolizumab to weekly paclitaxel (with or without University, Palo Alto, CA, USA chemotherapy with a median life expectancy of 1 year, overall bevacizumab) has reported an overall survival benefit in a less (E McClung MD); Gynecologic survival results are the most impactful efficacy endpoint. This pre-treated population. Additional studies will be needed to Oncology Unit (V Carbone MD), Department of Women and study provides a robust analysis that is mature, has determine the appropriate sequencing of these agents. Children’s Health Sciences considerable follow-up, was conducted per the prespecified (M C Cannizzaro MD), Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; Mount Sinai without bevacizumab, mirvetuximab soravtansine for planned interim overall survival analysis at the time of Comprehensive Cancer Center, approximately 33% of high-grade serous cancers that are primary progression-free survival analysis (50% maturity; Miami Beach, FL, USA folate receptor α-positive,5 trastuzumab deruxtecan for median follow-up, 13∙9 months), patients in the relacorilant (B Slomovitz MD); Humanitas San Pio X Hospital, Milan, Italy approximately 5% of ovarian cancers that have a HER2 combination group showed a 31% reduction in the risk of (E Giudice MD); Gentilly immunohistochemistry score of 3 or greater,6,7 and clinical death (HR 0∙69 [95% CI 0∙52–0∙92]; p=0∙012; conducted Oncology Center, Interregional trials.8 at an α=0∙0001 significance level, constituting the Institute of Oncology, Nancy, Acting through the glucocorticoid receptor, cortisol α spending function) and a 4∙5 month improvement in France (L Gavoille MD); Oncology Department of Grand provides survival signals to cancer cells, increasing the median overall survival compared with those receiving nab- Hôpital de Charleroi, Charleroi, expression of anti-apoptotic proteins. Relacorilant is paclitaxel monotherapy.12 The combination of relacorilant Belgium (A Devaux MD); a first-in-class selective glucocorticoid receptor antagonist plus nab-paclitaxel was well tolerated, with a safety profile Belgium and Luxembourg that inhibits cortisol survival signals and increases the similar to nab-paclitaxel monotherapy when adjusted for Gynaecological Oncology Group, Leuven, Belgium sensitivity of tumours to several classes of cytotoxic the duration of study treatment. Here, we report the (A Devaux, Prof T Van Gorp MD); chemotherapy.9–11 protocol-specified final overall survival analysis, subsequent Department of Medicine and The international, randomised, controlled, open-label, treatments, second progression-free survival, and patient- Surgery (Prof P Scollo MD) and phase 3 ROSELLA trial assessed the efficacy and safety of reported outcomes. Dipartimento di Medicina, (Prof G Scandurra MD), Kore relacorilant plus nab-paclitaxel compared with nab- University of Enna, Enna, Italy; paclitaxel alone in patients with platinum-resistant ovarian Methods Medical Oncology Unit, cancer. At the primary analysis, the relacorilant combination Study design Cannizzaro Hospital, Catania, Italy (Prof G Scandurra); group showed superior progression-free survival to those Full details regarding the ROSELLA trial have been Department of Clinical, receiving nab-paclitaxel monotherapy (hazard ratio [HR] published previously12 and are provided in the trial protocol Surgical, Diagnostic, and for disease progression or death 0∙70; p=0∙0076).12 In the in the appendix. In this randomised, controlled, parallel 1514 Articles group, open-label, superiority, phase 3 trial, approximately nab-paclitaxel monotherapy. A permuted block Pediatric Sciences, University 360 patients were planned to be randomly assigned 1:1 to randomisation method with block size of four was used. of Pavia, Pavia, Italy receive relacorilant plus nab-paclitaxel or nab-paclitaxel The random allocation sequence was developed by an (C Cassani MD); Unit of Obstetrics and Gynecology, monotherapy. The trial was conducted at 117 sites (an independent contract research organisation. Rando- IRCCS San Matteo Foundation, additional 12 sites were considered but did not open) in misation was centrally assigned using the Interactive Pavia, Italy (C Cassani); Azienda 14 countries, including hospital outpatient clinics and Response Technology System (IRT). The sponsor study ULSS2 Marca Trevigiana, Treviso, Italy (G Artioli MD); community oncology treatment centres across Australia, team, investigators, and site staff did not have access to University Hospital Leuven, Europe, Latin America, North America, and South Korea. the live randomisation schedule in the IRT. Region Leuven Cancer Institute, Criteria for site selection included experience conducting (North America vs Europe vs South Korea, Australia, and Leuven, Belgium registrational phase 3 ovarian cancer trials, anticipated Latin America) and previous lines of therapy (one vs (Prof T Van Gorp); Department of Medical Oncology, La Fe volume of eligible patients, ability to comply with the more than one) were stratification factors. University Hospital, IIS La Fe, protocol, research staff resourcing, and likelihood of Valencia, Spain activation within the anticipated enrolment timeframe of Procedures (Prof A Santaballa MD); Corcept the study. The trial was conducted in accordance with the Patients in the relacorilant combination group received Therapeutics, Redwood City, CA, USA (L K Dreiling MD, principles of the Declaration of Helsinki, Good Clinical 150 mg of relacorilant administered orally the day before, A Kesner-Hays PhD, Practice guidelines as defined by the International day of, and day after nab-paclitaxel infusion, in I C Tudor PhD, Council for Harmonisation, applicable regulatory combination with 80 mg/m² nab-paclitaxel administered A M Jubb FRCPath); Gynecologic requirements, and the bioethics policy of the trial sponsor. intravenously on days 1, 8, and 15 of each 28-day cycle. Oncology Program, European Institute of Oncology, IRCCS, The trial was approved by the Institutional Review Board Patients in the control group received 100 mg/m² of nab- Milan, Italy (N Colombo MD); or Ethics Committee of all participating centres (appendix paclitaxel monotherapy administered intravenously on University of Pittsburgh School pp 2–10). An Independent Data Safety Monitoring the aforementioned schedule. In the combination group, of Medicine and UPMC Magee– Committee had access to unblinded data and evaluated the dose of nab-paclitaxel was reduced because Women’s Hospital, Gynecologic Oncology Group, Pittsburgh, safety data at regular intervals in all dosed patients. To relacorilant is an inhibitor of CYP3A4,13 which is a minor PA, USA (A B Olawaiye MD) ensure the integrity of the data and to minimise the pathway of elimination for nab-paclitaxel (the major Correspondence to: potential for bias, the sponsor was blinded to aggregate pathway of elimination is CYP2C8, which is not affected Dr Domenica Lorusso, efficacy and safety data by treatment group until the by relacorilant in humans). Pharmacokinetic data from Humanitas San Pio X Hospital, primary analysis of progression-free survival and was the relacorilant phase 2 trial showed that the lower dose 31 20159 Milan, Italy domenica.lorusso@ blinded to additional accumulated aggregate efficacy and of nab-paclitaxel in the relacorilant combination group hunimed.eu safety data until the final analysis of overall survival. provides a comparable exposure to the nab-paclitaxel See Online for appendix There was no patient or public involvement in the design monotherapy group,11 and exposure–response analyses or conduct of this trial. The sponsor continues to engage showed that higher nab-paclitaxel exposures were not with patients and patient advocacy groups on the analysis, associated with improved efficacy in the phase 2 study.14 interpretation, and dissemination of these trial results. Publication of complete exposure–response analyses for This trial was registered at ClinicalTrials.gov, nab-paclitaxel and relacorilant in the phase 2 study and NCT05257408, and is ongoing. ROSELLA are planned in a peer-reviewed journal. Participants Outcomes Adult (aged ≥18 years) women with platinum-resistant The dual primary endpoints in the trial were progression- (defined as progression <6 months after their last dose free survival (defined as the time from randomisation to of platinum), high-grade, epithelial ovarian, primary disease progression or death due to any cause, whichever peritoneal, or fallopian-tube cancer who had received occurred first) assessed by blinded independent central one to three lines of prior systemic anticancer therapy, review and overall survival (defined as the time from had previous treatment with bevacizumab, and had randomisation to death due to any cause). Safety was measurable disease were eligible. Patients were a secondary endpoint. Second progression-free survival excluded if they had not responded to their initial (time from randomisation to progression on subsequent platinum-containing regimen or had disease anticancer therapy or death due to any cause, whichever progression within 1 month of their last dose of first- occurred first) and patient-reported outcomes were line platinum therapy. Full eligibility criteria are prespecified exploratory endpoints. provided in the trial protocol in the appendix. Race and The intention-to-treat population included all ethnicity were self-reported by patients using Clinical randomised patients, analysed according to the Data Interchange Standards Consortium standards, randomised treatment group. This population was used where permissible by local laws and regulations. All for the analysis of the dual primary endpoints of patients provided written informed consent. progression-free survival assessed by blinded independent central review and overall survival, as well Randomisation and masking as the exploratory endpoint of second progression-free Patients were enrolled by trial sites and randomly survival (assessed by the investigator). Overall survival assigned (1:1) to receive relacorilant plus nab-paclitaxel or and disease status were evaluated every 8 weeks for the Articles first 40 weeks, then every 12 weeks. Patients who factors at randomisation as covariates. The second discontinued treatment for any reason were followed for progression-free survival analysis was also performed in survival and subsequent treatments until death, the the intention-to-treat population using similar methods patient was lost to follow-up, or other study exit criteria to those used for the primary endpoints; patients alive were met. Where permissible, public records for survival and for whom a second disease progression had not been status were consulted if the patient was lost to follow-up. reported were censored at the time they were last known All efforts to reach the patient, including at least to be alive without second disease progression. three documented attempts, had to be exhausted before Descriptive statistics are provided for safety endpoints; a patient was deemed lost to follow-up. Cross-over was statistical methods for exposure-adjusted incidence rates not permitted and could not occur outside of the trial as are provided in the appendix (pp 11–12). relacorilant was not commercially available. Adverse For EORTC QLQ-OV28 and EORTC QLQ-C30 data, events were graded using the National Cancer Institute descriptive statistics (mean, SD, 95% CI, median, and Common Terminology Criteria for Adverse Events, range) of the observed scores at each visit and change version 5.0 and assessed in the safety population (all from baseline were summarised at each timepoint by randomised patients who received at least one dose of treatment group, for each scale and overall. In the assigned treatment). a prespecified analysis, the number of patients achieving Patient-reported outcomes were assessed in the safety at least a 15-point absolute improvement at week 8 or population at the time of the primary analysis (data cutoff week 9 in the abdominal or gastrointestinal scale of the Feb 24, 2025), using the European Organisation for QLQ-OV28 questionnaire was summarised by treatment Research and Treatment of Cancer (EORTC) ovarian group along with the 95% CI (computed using an exact cancer–specific quality-of-life questionnaire 28 binomial method). Similarly, the number of patients (QLQ-OV28), and the EORTC non-specific cancer achieving at least a 10-point absolute improvement at quality-of-life questionnaire core 30 (QLQ-C30) on the week 8 or week 9 in the abdominal or gastrointestinal first day of each cycle.15,16 scale was summarised as a sensitivity analysis. A stratified Cochran–Mantel–Haenszel test was used to test Statistical analysis differences in 15-point and 10-point absolute A group sequential weighted Holm procedure was used improvements in the abdominal or gastrointestinal scale for the dual primary endpoints, progression-free and of the QLQ-OV28 between treatment groups. Mean overall survival, in the intention-to-treat population. change in linear transformed scores between the groups Progression-free survival was tested at a two-sided was assessed, using a linear mixed model for repeated α=0∙04 level of significance using a stratified log-rank measures analysis that included the scores at each test. The primary endpoint of overall survival was assessment point up to the cycle 6, day 1 assessment. allocated a two-sided α=0·01 level of significance for the Least-square means for change from baseline to cycle 6, stratified log-rank test. If the null hypothesis for day 1, within groups and between groups, are reported progression-free survival by blinded independent central based on this model. When a patient had missing review was rejected, then, per the Holm procedure, QLQ-OV28 or QLQ-C30 data from a scheduled overall survival would be tested at α=0·05, using assessment, it was imputed with data from an a stratified log-rank test. The interim overall survival unscheduled or end of treatment assessment if these analysis was conducted at an α=0∙0001 significance level assessments were completed within one month of the (the α spending function). The final analysis of overall scheduled assessment timepoint. Data from all other survival was conducted at an α=0∙0499 significance level unscheduled assessments were not included. using a two-sided stratified log-rank test because progression-free survival was significant. With 1:1 Role of the funding source randomisation, approximately 292 events provided The trial was designed by the principal investigators 80% power to detect a 50% increase in progression-free and the sponsor. The sponsor supported trial conduct, survival (HR 0·66) with a log-rank test at a two-sided patient enrolment, and drug supply. The first draft of α=0·01 significance level. Assuming an exponential the manuscript was written by the authors, with distribution of overall survival, this corresponds to an medical writing support funded by the sponsor. increase in median overall survival from 13 months (benchmarked to phase 2 data) to 19∙4 months.11 All other Results secondary efficacy endpoints were tested at a nominal From Jan 5, 2023, to April 8, 2024, a total of 381 patients two-sided α=0∙05 level of significance, with no additional underwent randomisation with 188 participants adjustment for multiplicity. The Kaplan–Meier method allocated to the relacorilant combination group and 193 was used for all time-to-event endpoints to generate the to the nab-paclitaxel monotherapy group (figure 1). All survival curves and to estimate the medians. The HRs patients in the relacorilant combination group and were estimated using a Cox regression model with 190 patients in the nab-paclitaxel monotherapy group treatment group as the main effect and stratification received at least one dose of the assigned treatment. As 1516 Articles reported previously, baseline demographic and disease regimen were chemotherapy (182 [48%]), investigational characteristics were well balanced among the trial therapy (40 [11%]), chemotherapy plus bevacizumab groups (appendix pp 15–16).12 Patients were heavily pre- (13 [3%]), and mirvetuximab soravtansine (13 [3%]; treated: all had received bevacizumab; 167 (44%) had figure 3). Among all subsequent systemic anticancer received three prior lines of therapy, 234 (61%) had regimens, gemcitabine (128 [34%]), pegylated liposomal received a poly(ADP-ribose) polymerase inhibitor. doxorubicin (84 [22%]), investigational therapies 47 (12%) of 381 patients had BRCA-mutant ovarian (56 [15%]), and carboplatin (53 [14%]) were administered cancer, which is consistent with other published global the most (appendix p 18). Investigator-assessed second phase 3 studies in patients with platinum-resistant progression-free survival demonstrated a statistically ovarian cancer.5,17 significant improvement for the combination group The protocol-specified final analysis of overall survival compared with the nab-paclitaxel monotherapy group: was conducted after 288 deaths had been reported HR 0∙73 (95% CI 0∙58–0∙90); two-sided stratified (76% maturity). At the data cutoff (Jan 8, 2026), log-rank nominal p=0∙0037 (appendix p 14). 129 (69%) patients in the relacorilant combination Patient-reported outcomes baseline questionnaire group and 159 (82%) patients in the nab-paclitaxel data and completion rates are summarised in the monotherapy group had died. The addition of appendix (pp 19–20). The least-squares mean of the relacorilant to nab-paclitaxel resulted in a statistically difference between treatment groups for the QLQ-C30 significant improvement in overall survival (HR 0∙65 and the QLQ-OV28 scales was less than five (ie, less [95% CI 0∙51–0∙83]; two-sided stratified log-rank than the minimally important difference) for 20 of p=0∙0004; figure 2A, appendix p 17). With a median 22 questionnaire scales and symptom measures. Only follow-up of 24∙8 months (95% CI 23∙6–25∙7), median overall survival in the relacorilant combination group was extended by 4∙1 months compared with nab- 498 patients assessed for eligibility paclitaxel alone (16∙0 months [95% CI 13∙0–18∙3] vs 11∙9 months [10∙0–13∙8], respectively). A higher proportion of patients who received relacorilant plus 117 excluded nab-paclitaxel were alive at 18 months compared with 2 patient choice 1 investigator choice those who received nab-paclitaxel monotherapy (46% vs 12 withdrew consent 27%, respectively). The Kaplan–Meier curves remain 1 screening window elapsed 1 hospitalised well separated and increasingly divergent throughout 1 died the follow-up period, suggesting the addition of 99 did not meet eligibility criteria relacorilant offers a long-term benefit. The addition of relacorilant to nab-paclitaxel improved overall survival 381 randomly assigned across all prespecified subgroups (figure 2B). The proportional hazards assumption was not violated (supremum test p=0∙25). The restricted mean overall survival time at 30 months was 16∙6 months (95% CI 188 assigned to relacorilant plus 193 assigned to nab-paclitaxel (ITT nab-paclitaxel (ITT population)* population)* 15∙0–18∙1) in the relacorilant combination group and 13∙4 months (95% CI 11∙7–15∙0) in the nab-paclitaxel monotherapy group, a difference of 3∙2 months 3 did not receive treatment (95% CI 0∙9–5∙5; two-sided test of equality nominal p=0∙0059). 188 received treatment (safety 190 received treatment (safety In total, 127 (68%) of 188 patients from the relacorilant population)† population)† combination group and 139 (72%) of 193 patients from the nab-paclitaxel monotherapy group received subsequent systemic anticancer treatment, and 185 discontinued treatment 189 discontinued treatment 134 progressive disease 145 progressive disease 128 (68%) of 188 patients from the relacorilant 17 adverse event 18 adverse event combination group and 140 (73%) of 193 patients from 11 clinical progression 13 clinical progression the nab-paclitaxel monotherapy group received 23 other 13 other subsequent anticancer treatment when radiotherapy is included. The median time to start the first subsequent 3 still receiving treatment‡ 1 still receiving treatment‡ anticancer treatment was 6∙2 months (range 1∙1–23∙7) in the relacorilant combination group versus Figure 1: Trial profile 5∙6 months (range 0∙9–21∙6) in the nab-paclitaxel Three patients in the nab-paclitaxel monotherapy group withdrew consent and did not receive treatment. monotherapy group. First and all subsequent anticancer ITT=intention-to-treat. *All randomly assigned patients were analysed according to the randomised treatment group. †All randomly assigned patients who received at least one dose of study treatment (ie, relacorilant plus treatments were similar in both treatment groups. The nab-paclitaxel or nab-paclitaxel monotherapy). ‡Refers to patients on nab-paclitaxel at the data cutoff of most common classes of agents in the first subsequent Jan 8, 2026. Articles Relacorilant plusNab-paclitaxel nab-paclitaxel monotherapy (n=188) (n=193) Events, n (%) 129 (69%) 159 (82%) Median overall survival, 16·0 (13·0–18·3) 11·9 (10·0–13·8) months (95% CI) Hazard ratio (95% CI) 0·65 (0·51–0·83) p value (two-sided 0·0004 stratified log-rank test) Relacorilant plus nab-paclitaxel Nab-paclitaxel monotherapy 0 3 6 9 12 15 18 21 24 27 30 33 Time since randomisation (months) Number at risk (censored) Relacorilant plus 188 176 148 123 106 93 81 67 28 10 3 0 nab-paclitaxel (0) (1) (7) (9) (9) (9) (9) (9) (33) (49) (56) (59) Nab-paclitaxel 193 173 142 110 91 72 49 33 18 5 1 0 monotherapy (0) (5) (8) (8) (9) (9) (9) (10) (22) (29) (33) (34) Patients, n Events, n Hazard ratio for overall survival (95% CI) All patients 381 288 0·65 (0·51–0·83) Age (years) <65 229 172 0·75 (0·55–1·01) ≥65 152 116 0·58 (0·39–0·85) Region North America 90 71 0·47 (0·28–0·78) Europe 216 169 0·72 (0·53–0·97) South Korea, Australia, and Latin America 75 48 0·73 (0·40–1·31) ECOG performance status 0 262 189 0·65 (0·48–0·87) 1 115 97 0·62 (0·40–0·95) Previous lines of therapy 1 33 30 0·91 (0·43–1·96) 2 181 136 0·68 (0·48–0·96) 3 167 122 0·60 (0·41–0·86) Prior PARP inhibitor Yes 234 173 0·70 (0·51–0·95) No 147 115 0·67 (0·46–0·98) Primary platinum-free interval (months) ≤6 112 88 0·61 (0·39–0·96) >6 269 200 0·68 (0·51–0·91) BRCA1/2 mutation Positive 47 40 0·76 (0·39–1·51) Negative or unknown 334 248 0·66 (0·51–0·85) Taxane in last regimen Yes 73 64 0·67 (0·38–1·19) No 308 224 0·63 (0·48–0·82) Taxane-free interval (months) ≤6 55 50 0·60 (0·31–1·15) >6 324 237 0·66 (0·51–0·86) Histology High-grade serous 371 280 0·66 (0·52–0·84) Non-serous 10 8 0·47 (0·08–2·62) Largest target lesion (cm) <5 299 221 0·60 (0·45–0·79) ≥5 45 37 0·65 (0·33–1·29) Favours relacorilant Favours control 1518 )%( lavivrus llarevO A 80 60% 46% 40 50% 27% B Figure 2: Overall survival (A) Kaplan–Meier estimates of overall survival (time from randomisation to death from any cause) among patients who received relacorilant plus nab-paclitaxel and those who received nab-paclitaxel monotherapy. (B) Results of exploratory subgroup analyses of overall survival in the intention-to-treat population represented as forest plots. The HRs reported throughout the figure are based on a Cox proportional hazards model, stratified according to the randomisation factors that were collected in the interactive response technology system, except when the randomisation factor was the subgroup under analysis; in which case, only a single stratification variable was used. Under the assumption of proportional hazards, a HR of less than 1 indicates a reduction in the hazard in favour of the combination group. Circles and triangles indicate censored data. BRCA=breast cancer gene. HR=hazard ratio. ECOG=Eastern Cooperative Oncology Group. 0 0·5 1·0 1·5 2·0 2·5 PARP=poly(ADP-ribose) polymerase. Articles two items reached the minimally important difference primary analysis. The overall frequencies of grade 3 or threshold, favouring the nab-paclitaxel monotherapy worse adverse events (141 [75%] vs 113 [59%]), all serious group: nausea and vomiting (least-squares mean of adverse events (66 [35%] vs 45 [24%]), and grade 3 or difference 5∙32, 95% CI 2∙25–8∙39; nominal p=0∙0007) worse neutropenia (82 [44%] vs 48 [25%]), anaemia and appetite loss (least-squares mean of difference (34 [18%] vs 17 [9%]), and fatigue (17 [9%] vs 3 [2%]) were 7∙75, 95% CI 3∙18–12∙32; p=0∙0009); both were under numerically higher in the combination group, which had the clinically meaningful threshold of a 10-point a 30% longer median treatment duration with nab- difference in the least-square mean of the difference paclitaxel compared with the nab-paclitaxel monotherapy (appendix p 21). group, respectively (4·52 months [range 0∙0–23∙6] vs In an evaluation of at least 15-point and at least 3·48 months [0·0–25∙2]; appendix p 13). No further 10-point improvements in the abdominal or serious adverse events of febrile neutropenia or sepsis, or gastrointestinal symptoms scale of the EORTC deaths on treatment were reported with additional QLQ-OV28 at week 8 or week 9, neither showed follow-up since the primary analysis of progression-free significant differences between treatment groups (two- survival (appendix p 23). White blood cell growth factor sided stratified Cochran–Mantel–Haenszel test nominal use was at the discretion of the investigator and did not p=0∙10 and nominal p=0∙20; appendix p 22). change with additional follow-up; growth factor use was At the time of the final overall survival analysis, the more frequent in the combination group (84 [45%] safety profile of the relacorilant combination was patients; 52 [28%] as prophylaxis and 50 [27%] for adverse consistent with the safety profile at the time of the events) than in the nab-paclitaxel monotherapy group primary analysis. Neutropenia (121 [64%]), anaemia (41 [22%] patients; 29 [15%] as prophylaxis and 31 [16%] (115 [61%]), fatigue (101 [54%]), and nausea (82 [44%]) for adverse events). The confidence intervals for were the most common treatment-emergent adverse exposure-adjusted incidence rate differences between events in the relacorilant combination group. The overall groups overlapped zero for all serious adverse events, incidence of any grade and grade 3 or higher including febrile neutropenia, and for the treatment- treatment-emergent adverse events (table 1), and emergent adverse events of neutropenia and anaemia treatment-emergent serious adverse events (table 1; appendix p 23) were similar to those reported in the 90 80 60 40 20 0 Figure 3: First subsequent anticancer therapies First subsequent therapy received by 128 (68%) of 188 patients from the relacorilant combination group and 140 (73%) of 193 patients from the nab-paclitaxel monotherapy group who discontinued their assigned trial treatment and received subsequent therapy. Chemotherapy included both monotherapy and combination regimens. The most-used chemotherapy agents in the first subsequent regimen in the relacorilant combination group (n=188) versus the nab-paclitaxel monotherapy group (n=193) were gemcitabine (34 [18%] vs 38 [20%]), pegylated liposomal doxorubicin (31 [17%] vs 31 [16%]), carboplatin (eight [4%] vs 11 [6%]), and topotecan (four [2%] vs ten [5%]). PARP=poly(ADP-ribose) polymerase. *Monotherapy or combination therapy. )%( stnapicitrap fo noitroporP Relacorilant plus Nab-paclitaxel monotherapy Chemotherapy Chemotherapy plus bevacizumab nab-paclitaxel (n=188) (n=190) Mirvetuximab soravtansine* Investigational therapy Any grade Grade ≥3 Any grade Grade ≥3 Hormonal therapy Immunotherapy PARP inhibitor combination Trastuzumab deruxtecan* Any adverse event 188 (100%) 141 (75%) 189 (99%) 113 (59%) Radiotherapy Any serious adverse event 66 (35%) 60 (32%) 45 (24%) 39 (21%) 2 1 0 1 Any adverse event resulting in death 4 (2%)* .. .. .. 10 1 1 11 1 1 A di n sc y o a n d t v in er u s a e t e io v n ent leading to relacorilant 19 (10%) .. .. .. 2 3 1 4 3 Any adverse event leading to nab- 18 (10%) .. 15 (8%) .. 4 paclitaxel discontinuation Adverse events reported in ≥20% of the patients in either group (by preferred term) Neutropenia† 121 (64%) 82 (44%) 93 (49%) 48 (25%) Anaemia‡ 115 (61%) 34 (18%) 106 (56%) 17 (9%) Fatigue§ 101 (54%) 17 (9%) 85 (45%) 3 (2%) 45 Nausea 82 (44%) 7 (4%) 68 (36%) 6 (3%) Diarrhoea 74 (39%) 7 (4%) 52 (27%) 3 (2%) Alopecia 72 (38%) 1 (1%) 59 (31%) 0 Constipation 62 (33%) 1 (1%) 51 (27%) 0 Abdominal pain 55 (29%) 4 (2%) 54 (28%) 2 (1%) Relacorilant plus Nab-paclitaxel Vomiting 49 (26%) 5 (3%) 43 (23%) 3 (2%) nab-paclitaxel (n=128) monotherapy (n=140) Decreased appetite 41 (22%) 3 (2%) 22 (12%) 1 (1%) Hypomagnesaemia 40 (21%) 3 (2%) 36 (19%) 2 (1%) *There were four deaths on study treatment (or within 30 days of the last dose of study drug) due to adverse events, all in the combination group (one each due to cardiac arrest, intestinal perforation, ischaemic stroke, and septic shock). One death (septic shock, on study day 87 in a patient with febrile neutropenia) was considered related to nab-paclitaxel by the investigator, and none of the deaths were related to relacorilant. The cause of death for the other three patients was attributed to their advanced ovarian cancer. †Combined term including neutropenia, decreased neutrophil count, and febrile neutropenia. ‡Combined term including anaemia, decreased haemoglobin, and decreased red blood cell count. §Combined term including fatigue and asthenia. Table 1: Adverse events in the safety population Articles subsequent lines of treatment. Although a significant Relacorilant plus Nab-paclitaxel improvement was not observed for exploratory patient- nab-paclitaxel (n=188) monotherapy (n=190) reported outcome endpoints, the absence of a clinically Alanine aminotransferase or aspartate aminotransferase increase meaningful detriment for the relacorilant combination >3–5 × ULN 3 (2%) 13 (7%) group supports the conclusion that this regimen is >5–8 × ULN 4 (2%) 3 (2%) manageable by patients. >8–10 × ULN 2 (1%) 0 The final overall survival results for relacorilant plus >10 × ULN 1 (1%) 2 (1%) nab-paclitaxel compare well with the results from other Total bilirubin increase contemporaneous phase 3 trials such as MIRASOL, >2 × ULN 3 (2%) 4 (2%) which compared mirvetuximab soravtansine to Alkaline phosphatase increase investigator’s choice chemotherapy.25 Clinical outcome >2 × ULN 16 (9%) 24 (13%) data for relacorilant and nab-paclitaxel in patients with Hy’s law* criteria met 0 0 folate receptor α-positive platinum-resistant ovarian ULN=upper limit of normal. *Hy’s Law is a clinical rule stating that a drug is likely to cause serious liver injury when a cancer could help to support treatment decisions and patient develops alanine aminotransferase or aspartate aminotransferase 3 × or greater the upper limit of normal appropriate sequencing of relacorilant plus nab-paclitaxel together with total bilirubin greater than 2 × the upper limit of normal, without evidence of cholestasis or another and mirvetuximab soravtansine in an evidence-based explanation. paradigm. In the absence of head-to-head data comparing Table 2: Summary of liver function test abnormalities in the safety population these agents in a population with folate receptor α-positive disease, their order of use will depend on (appendix p 24). There were no reported cases of adrenal patient preference for their distinct safety profiles and insufficiency or any cases with signs and symptoms the practicality of waiting for biomarker testing results in indicative of adrenal insufficiency. The frequency of liver patients whose disease is progressing rapidly. function test abnormalities was low and similar across The addition of bevacizumab to chemotherapy in the treatment groups (table 2); no cases met Hy’s Law AURELIA trial showed a significant improvement in criteria.18 progression-free survival but did not result in a significant improvement in the key secondary endpoint of overall Discussion survival, probably due, in part, to crossover to the The phase 3 ROSELLA trial met its dual primary investigational group at progression.4,22 Moreover, in the endpoints: the addition of relacorilant to nab-paclitaxel for current era, bevacizumab is predominantly used to treat patients with platinum-resistant ovarian cancer resulted patients in the front line and those with recurrent in a statistically and clinically significant improvement in platinum-sensitive ovarian cancer,26 and there is no progression-free survival (HR 0∙70; p=0∙0076)12 and evidence from prospective trials to support bevacizumab overall survival (HR 0∙65; p=0∙0004). This was a robust rechallenge in patients with platinum-resistant disease. analysis: the median follow-up exceeds the median overall All patients in the ROSELLA trial had previously received survival in each study group by more than 8 months, the bevacizumab, a key distinction from AURELIA, and overall survival data is mature (76%), the dataset is relevant to current clinical practice. Subgroup analyses complete (only 5% of patients did not have a documented for overall survival in the phase 2 study of relacorilant vital status at the final analysis data cutoff [Jan 8, 2026]), plus nab-paclitaxel in patients with platinum-resistant the proportional hazards assumption was not violated, ovarian cancer showed a benefit in both bevacizumab- and subsequent therapies were well balanced across study exposed and bevacizumab-naive populations,11 suggesting groups. The nab-paclitaxel monotherapy group performed that this combination regimen is an appropriate choice as expected for single-agent chemotherapy in this setting, irrespective of previous bevacizumab treatment. with a median overall survival of 11∙9 months versus Moreover, given the potential for additive benefit, the a range of 11∙1 to 14∙4 months in contemporaneous combination of bevacizumab with relacorilant plus nab- trials.3,4,11,17,19–24 Moreover, overall survival analyses paclitaxel is being explored in an ongoing study consistently favoured the relacorilant combination group (NCT06906341). in all prespecified subgroups, including in poor prognosis Anti-PD(L)1 therapy has been extensively evaluated in populations. The efficacy results from ROSELLA confirm patients with ovarian cancer. To date, 12 randomised the progression-free survival (HR 0∙66) and overall controlled phase 3 trials of anti-PD(L)1 agents have been survival (HR 0∙67) benefit observed in the randomised completed,23,27–37 including four in patients with platinum- controlled phase 2 study (NCT03776812), and position resistant ovarian cancer.23,35–37 Of these four trials, one, selective glucocorticoid receptor antagonism as KEYNOTE-B96, reported a significant overall survival a promising novel mechanism of action in many benefit (HR 0∙76) in the prespecified PDL1 combined applicable oncology settings.11 positive score of 1 or greater primary analysis population,36 A significant improvement in second progression-free which has a relatively good prognosis.38 Final overall survival suggests that the treatment benefit from the survival data and peer-reviewed publication will inform addition of relacorilant to nab-paclitaxel extends into the benefit–risk of the KEYNOTE-B96 regimen in the 1520 Articles overall and biomarker-selected populations and among and can be further validated by analyses of glucocorticoid different histological subtypes.39 The choice between receptor expression in tumour and immune cells, these regimens probably reflects tissue availability, diurnal cortisol levels, and markers of glucocorticoid biomarker testing timelines and status, the number of receptor pathway activation in future clinical trials. previous lines of therapy, preferences for an oral and ROSELLA study limitations include the open-label intravenous combination versus three intrav enous design and the applicability of these results to patients therapies, and patient preference between the distinct with greater than three lines of anticancer therapy. The adverse event profiles. These new treatments with limitations of an open-label design are mitigated by the diverse mechanisms of action provide much needed objectivity of the dual primary endpoints (blinded options for patients with advanced ovarian cancer; independent central review for progression-free survival additional work to determine the optimal patient and overall survival), the consistency of the benefit selection for these therapies will help to maximise the across primary and secondary efficacy endpoints, and benefit in routine clinical practice. the prespecified statistical analysis plan. A consistent Nab-paclitaxel is a rational combination partner for progression-free and overall survival benefit was a trial investigating relacorilant—a selective, competitive, observed in subgroups of patients who had received reversible glucocorticoid receptor antagonist—as it does one, two, and three previous lines of anticancer therapy.12 not require pretreatment with corticosteroids that In the phase 2 study, which permitted the enrolment of agonise the glucocorticoid receptor. To delineate the patients with up to four previous lines of anticancer contribution of components in the investigational group, therapy,11 a similar benefit from the addition of weekly nab-paclitaxel at a dose of 100 mg/m² was chosen relacorilant to nab-paclitaxel was observed. Additional as the control group chemotherapy. Although nab- clinical studies might prove the utility of relacorilant paclitaxel is not currently approved for use in patients and nab-paclitaxel in more heavily pretreated patients. with ovarian cancer by the FDA or EMA, this choice was Although both ROSELLA and the phase 2 study enrolled supported by a National Comprehensive Cancer Network patients with non-serous high-grade histologies, the Compendia evidence category 2A assessment of nab- numbers of patients with these rarer ovarian cancers paclitaxel for the treatment of patients with were too few to allow meaningful conclusions to be platinum-resistant ovarian cancer.8 Moreover, phase 2 drawn among different histological subtypes. An data from Coleman and colleagues40 and the relacorilant additional limitation of the ROSELLA study design is development programme11 showed similar safety and that patient-reported outcomes were only collected until efficacy for this dose and schedule of nab-paclitaxel to the end of treatment visit. Continued collection of these published data for weekly paclitaxel (an approved taxane data after the end of study treatment might have therapy) in patients with platinum-resistant ovarian increased the potential to discriminate between study cancer. Real-world evidence also shows similar outcomes groups, but might also have been confounded by the for nab-paclitaxel and paclitaxel monotherapy in this impact of subsequent treatments. population.41 In ROSELLA, the nab-paclitaxel mono- The participants in ROSELLA were enrolled globally in therapy control group showed a median progression-free 14 countries across Australia, Europe, Latin America, survival of 5∙5 months,12 a median overall survival of North America, and South Korea. Consistent with disease 11∙9 months, and an adverse event profile that is distribution among ethnicities, White people were the consistent with data for weekly paclitaxel in recent most highly represented group in the study. The phase 3 studies17,19 in this setting. These data support proportion of Black or African American and Hispanic weekly nab-paclitaxel monotherapy as an appropriate participants was low (five [1%] and 33 [9%], respectively). comparator for a randomised controlled trial in patients However, there was a higher proportion of Asian with platinum-resistant ovarian cancer. participants (48 [13%]). Of note, 57 (15%) participants did Relacorilant selectively antagonises the glucocorticoid not report their race or ethnicity. receptor, providing a new and unique mechanism to Relacorilant showed a consistent safety profile; no new improve survival outcomes. Unlike folate receptor α and safety signals were identified with longer follow-up since immune checkpoints, the glucocorticoid receptor is the primary analysis. The nature of the adverse events expressed by the tumour cells of more than 95% of reported with relacorilant plus nab-paclitaxel is consistent epithelial ovarian cancers.42 In the relacorilant phase 2 with the established nab-paclitaxel monot herapy safety study (NCT03776812),42 the level of tumour cell profile. Higher rates of grade 3 or worse neutropenia and glucocorticoid receptor expression was evaluated by anaemia were observed for the combination group but immunohistochemistry in patients with available tissue. were similar following adjustment for the duration of Exploratory analyses showed a similar progression-free study drug treatment, were well managed with standard survival benefit from the addition of relacorilant to nab- supportive care, and did not add to the patient safety paclitaxel in each tertile of glucocorticoid receptor burden. Glucocorticoids do not stimulate granulopoiesis,43 expression.42 These phase 2 glucocorticoid receptor and neutropenia has not been reported for relacorilant biomarker data support the all-comers ROSELLA design monotherapy.44–46 Therefore, the increased frequency of Articles neutropenia is most probably due to prolonged duration presentations, speakers bureaus, manuscript writing or educational of treatment with nab-paclitaxel in the combination group, events from Covidien/Medtronic, Pharmaand, and AbbVie; and and pharmacodynamic synergy between relacorilant and participation on a data safety monitoring board or advisory board at GSK. LGi reports grants or contracts from Alkermes, Ascendis, nab-paclitaxel, increasing apoptosis of myeloid progenitor AstraZeneca, Bayer, CanariaBio, Corcept Therapeutics, Daiichi Sankyo, cells. However, the glucocorticoid receptor regulates Eisai, Espersas, Fortrea, Gilead Science, GOG Foundation, GSK, erythropoietin and increases the sensitivity of erythroid Immunogen, IMV, K-Group Beta, Karyopharm, Macrogenics, Merck, Mersana Therapeutics, Novocure, OncoQuest Pharmaceuticals, Paraxel progenitors to erythropoietin.47–51 Low-grade anaemia has International Therapeutics, Pfizer, Pri-Wex Pharma, Roche, Seagen, been reported for relacorilant monot herapy,52 suggesting Shattuck Labs, Sichuan Kelun Biotech, Sutro Bio Pharma, Tesaro, and that the increased rates of anaemia could reflect both an Verastem; consulting fees from Merck, AbbVie, and GSK; and additive effect and prolonged duration of treatment with participation on a data safety monitoring board or advisory board at Merck, GSK, Eisai, and Repare Therapeutics. LM reports medical writing nab-paclitaxel in the combination group. Nab-paclitaxel is support for this manuscript from Corcept. SQ reports payment or a known cause of transaminitis;53 the frequency observed honoraria from AstraZeneca, GSK, MSD, Pharma&, Eisai, and AbbVie; in ROSELLA is consistent with the reported literature and support for attending meetings from GSK, MSD, Pharma&, Eisai, and was not increased with the addition of relacorilant. AbbVie; and participation on a data safety monitoring board or advisory board at AstraZeneca, GSK, MSD, Pharma&, Eisai, and Servier. In summary, the addition of relacorilant to nab- EH reports participation in advisory board meeting for Corcept. paclitaxel showed a progression-free and overall survival AO reports consulting fees from AbbVie, Agenus, AstraZeneca, Clovis, benefit in patients with platinum-resistant ovarian Corcept, Deciphera, Daiichi Sankyo, Debiopharm International, Eisai, cancer. These outcomes—a 35% reduction of the risk of Exelixis, F Hoffmann–La Roche, Genmab, GSK, ImmunoGen, Itheos, MSD, Mersana, Myriad Genetics, Novocure, OncoXerna, PharmaMar, death from any cause and a median overall survival Regeneron, Sattucklabs, Seagen/Pfizer, Stemline Therapeutics, Sutro improvement of 4∙1 months—position relacorilant plus Biopharma, TORL Bio Therapeutics, Zentalis, and Zymeworks; payment nab-paclitaxel as a new standard treatment option for or honoraria from the NSGO, Peerview, Peervoice, Medscape, Asociación patients with platinum-resistant ovarian cancer, without Colombiada de Ginecológos Oncólogos, the ESO, AstraZeneca, and GSK; support for attending meetings from AstraZeneca, PharmaMar, the need for biomarker selection. and Roche; and participation on a data safety monitoring board or Contributors advisory board for Agenus, AstraZeneca, Clovis Oncology, Corcept, All authors provided resources, critically reviewed and edited the Deciphera Pharmaceuticals, Daiichi Sankyo, Debiopharm International, manuscript, approved the final version, and agreed to be accountable for Eisai, Exelixis, F Hoffmann–La Roche, Genmab, GSK, ImmunoGen, all aspects of the work. All authors were given the opportunity to access Itheos, MSD, Mersana, Myriad Genetics, Novocure, OncoXerna, the data in the study and agreed to submit for publication. DL, DMO, PharmaMar, Regeneron, Sattucklabs, Seagen/Pfizer, Stemline BJM, LKD, ICT, and ABO conceptualised the study. ICT curated the data, Therapeutics, Sutro Biopharma, TORL Bio Therapeutics, Zentalis, and used data software, and performed data validation. AK-H, ICT, and AMJ Zymeworks; and leadership or fiduciary roles at Gynecologic Cancer were involved with formal analyses and visualisation. LKD, AK-H, ICT, Intergroup cervical cancer committee chair; ESMO Gyn subject editor and AMJ were involved with study methodology. Project administration guidelines; ESMO Gyn meeting chair; and ESMO Gyn faculty member; was led by DL, DMO, J-WK, LM, BJM, LKD, AK-H, ICT, AMJ, and ABO. and other financial or non-financial interests in Gynecologic Cancer DL, DMO, J-WK, LM, LKD, ICT, AMJ, and ABO provided supervision. Intergroup, European Society for Medical Oncology, American Society of DL, LGl, J-WK, GG, AF, LGi, LM, SQ, EH, YJL, AO, MS, B-GK, AC, CP, Clinical Oncology, Spanish Society of Medical Oncology, and the GOG CD, AB, ALL, VS, BJM, PF, EM, VC, BS, EG, MCC, LGa, AD, PS, GS, Foundation. MS reports research funding from AstraZeneca, AbbVie, CC, GA, TVG, AS, LKD, AK-H, ICT, AMJ, NC, and ABO were involved and Gilead; consulting fees from GSK, AbbVie, MSD and AstraZeneca; with the study investigation. DL, LGl, SQ, AO, BJM, TVG, LKD, AK-H, payment or honoraria from MSD, GSK, AstraZeneca, and AbbVie; ICT, AMJ, and ABO were involved with writing of the original draft. support for attending meetings from MSD, AstraZeneca, GSK, and Daiichi Sankyo; and participation on data safety monitoring or advisory Declaration of interests boards for MSD, GSK, AstraZeneca, and AbbVie; and leadership or DL reports grants or contracts from AstraZeneca, AbbVie, GSK, Incyte, fiduciary role in Sociedade Brasileira de Oncologia Clínica. AC reports MSD, and Corcept; consulting fees from AstraZeneca, AbbVie, GSK, support for the present manuscript from Corcept; grants or contracts Genmab, MSD, and Pharma&; support for attending meetings or travel from Advenchen; payment or honoraria from AbbVie and Pharma&; and from GSK, AbbVie, AstraZeneca, and MSD; and participation on a data support for attending meetings or travel from AbbVie. CP reports stock safety monitoring board or advisory board at AstraZeneca, AbbVie, or stock options in AbbVie, Johnson & Johnson, Pfizer, Amgen, Merck, Corcept, Genmab, GSK, Regeneron, and MSD. LGl reports support for Gilead, and Bristol Myers Squibb. VS reports payment or honoraria attending meetings or travel from AbbVie and MSD. DMO reports from MSD, AstraZeneca, GSK, Menarini, Pharma&, AbbVie, and Eisai; support for the present manuscript from Corcept; grants or contracts support for attending meetings or travel from MSD, AstraZeneca, from AbbVie, Advaxis, Agenus, Alkermes, Aravive, Arcus, AstraZeneca, Pharma&, and Menarini; and participation on a data safety monitoring BeiGene, Boston Biomedical, Bristol Myers Squibb, Clovis, Deciphera board or advisory board at MSD, AstraZeneca, GSK, Pharma&, AbbVie, Pharma, Eisai, EMD Serono, Exelixis, Genentech, Genmab, GSK, the and Eisai. BJM reports consulting fees from AstraZeneca, BioNTech, Gynecologic Oncology Group Foundation, F Hoffmann–La Roche, Corcept, DSI, Eisai, Eli Lilly, Genmab–Seagen–Pfizer, the Gynecologic ImmunoGen, Incyte, IOVANCE, Karyopharm, Leap, the Ludwig Oncology Group Foundation, GSK, ImmunoGen–AbbVie, Incyte, Institute for Ca, Merck & Co, Merck Sharp & Dohme, Mersana, NCI, Karyopharm, Merck, Mersana, Mural/Alkermes, Myriad, Natera, Novartis, NovoCure, NRG Oncology, OncoC4, OncoQuest, Pfizer, Novartis, Novocore, OncoC4, Panavance, Pharmaand, ProfoundBio, Precision Therapeutics, Prelude Therapeutics, Regeneron, the RTOG, Genmab, Regeneron, Roche–Genentech, Sutro Biopharma, Tubulis, Rubius Therapeutics, Seattle Genetics, Sutro Biopharma, SWOG, and Verastem Oncology, Zentalis, and Zymeworks; and payment or Verastem; consulting fees from or advisory boards for AbbVie, honoraria from AstraZeneca, DSI, Eisai, GSK, Immunogen/AbbVie, and AstraZeneca, Corcept, Duality Bio, Eli Lilly, GSK, the Gynecologic Merck. PF reports consulting fees from AbbVie, GSK, Novartis, and Oncology Group Foundation, Merck & Co, Merck Sharp & Dohme, Daiichi; payment or honoraria from MSD, AbbVie, and Novartis; Regeneron Pharmaceuticals, Verastem, and Zentalis; and a leadership or payment for expert testimony from AbbVie, Regeneron, and GSK; fiduciary role at the Gynecologic Oncology Group Foundation Board of support for attending meetings or travel from AbbVie, Novartis, and Directors. AF reports grants or contracts from AstraZeneca and MSD; Daiichi; and participation on data safety monitoring or advisory boards consulting fees from Oncoinvent; payment or honoraria for lectures, for AbbVie. EM reports grants or contracts from Stanford Cancer 1522 Articles Institute. BS reports consulting fees from MSD, AstraZeneca, Daiichi Hristina Pashova, Amy Plodek, Kristie Kooken, Anju Parthan, and Sankyo, Incyte, Seagen, Novocure, Karyopharm, Genmab, Aadi, Abhijit Ramachandran, employees of Corcept Therapeutics. Regeneron, Immunocore, Gilead, Eisai, Beigene, and GSK. EG reports References participation on data safety monitoring or advisory boards for Daiichi 1 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: Sankyo, Amgen, and MSD; support for attending meetings or travel GLOBOCAN estimates of incidence and mortality worldwide for from MSD; and payment or honoraria from GSK, EISAI, MSD, and 36 cancers in 185 countries. CA Cancer J Clin 2024; 74: 229–63. AstraZeneca. MCC reports support for attending meetings or travel from 2 International Agency for Research on Cancer. Global cancer AstraZeneca. AD reports support for attending meetings or travel from observatory: cancer tomorrow. 2025. https://gco.iarc.fr/tomorrow/ GSK, Novartis, AstraZeneca, and Gilead. CC reports consulting fees, en/dataviz/tables?populations=908&sexes=2&cancers=25&years= payment or honoraria, and participation on data safety monitoring or 2050&types=1 (accessed Feb 25, 2026). advisory boards for AstraZeneca and GSK; and leadership or fiduciary 3 Banerjee S, Giannone G, Clamp AR, et al. Efficacy and safety of role at Abracadabra advocacy group. GA reports payment or honoraria weekly paclitaxel plus vistusertib vs paclitaxel alone in patients with from GSK, AstraZeneca, and Pharmaand; and support for attending platinum-resistant ovarian high-grade serous carcinoma: the meetings or travel from GSK and AstraZeneca. TVG reports grants or OCTOPUS multicenter, phase 2, randomized clinical trial. contracts from Amgen, AstraZeneca, and Roche; consulting fees from JAMA Oncol 2023; 9: 675–82. AbbVie, AstraZeneca, BeiGene, BioNTech, Cancer Communications and 4 Pujade-Lauraine E, Hilpert F, Weber B, et al. Bevacizumab Consultancy, Daiichi Sankyo, Eisai, Eli Lilly, Genmab, GSK, combined with chemotherapy for platinum-resistant recurrent ImmunoGen, Incyte, Karyopharm, MSD–Merck, OncXerna, Seagen, ovarian cancer: the AURELIA open-label randomized phase III trial. J Clin Oncol 2014; 32: 1302–08. TORL Bio Therapeutics, Tubulis, Verastem, and Zentalis; honoraria for lectures from AbbVie, AstraZeneca, Eisai, GSK, ImmunoGen, and MSD; 5 Moore KN, Angelergues A, Konecny GE, et al. Mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer. support for attending meetings from ImmunoGen, MSD, and N Engl J Med 2023; 389: 2162–74. PharmaMar; and leadership or fiduciary role as the Chair of the Belgian 6 Tuefferd M, Couturier J, Penault-Llorca F, et al. HER2 status in and Luxembourg Gynaecological Oncology Group. AS reports consulting ovarian carcinomas: a multicenter GINECO study of 320 patients. fees from MSD, AstraZeneca, and AbbVie; payments or honoraria from PLoS One 2007; 2: e1138. MSD and AstraZeneca; support for attending meetings from 7 Meric-Bernstam F, Makker V, Oaknin A, et al. Efficacy and safety of AstraZeneca and MSD; and participation on a data safety monitoring trastuzumab deruxtecan in patients with HER2-expressing solid board or advisory board at AstraZeneca, MSD, and AbbVie. LKD reports tumors: primary results from the DESTINY-PanTumor02 phase II support for the present manuscript and stock or stock options in trial. J Clin Oncol 2024; 42: 47–58. Corcept. AK-H reports stock or stock options in Corcept and Exelixis. 8 National Comprehensive Cancer Network. NCCN Clinical Practice ICT reports support for the present manuscript, employment, and stock Guidelines in Oncology for Ovarian Cancer (Version 1·2026). 2026. or stock options in Corcept; and leadership or fiduciary role as Member https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf of the Board of Directors at Bay Area Biotech-Pharma Statistics (accessed Feb 25, 2026). Workshop. AMJ reports employment and stock or stock options in 9 Greenstein AE, Hunt HJ. Glucocorticoid receptor antagonism Corcept. NC reports support for the present manuscript from Corcept; promotes apoptosis in solid tumor cells. Oncotarget 2021; grants or contracts from AstraZeneca and GSK; payment or honoraria 12: 1243–55. from AstraZeneca, GSK, MSD, AbbVie, Pharmaand, Corcept, and Eisai; 10 Munster PN, Greenstein AE, Fleming GF, et al. Overcoming taxane support for attending meetings from GSK, AstraZeneca, and AbbVie; resistance: preclinical and phase 1 studies of relacorilant, a selective participation on data safety monitoring or advisory boards for Roche, glucocorticoid receptor modulator, with nab-paclitaxel in solid AstraZeneca, MSD, Eisai, GSK, ImmunoGen, Oncxerna, Nuvation Bio, tumors. Clin Cancer Res 2022; 28: 3214–24. Gilead, Regeneron, Novocure, Seagen, AbbVie, Eli Lilly, BeOne, and 11 Colombo N, Van Gorp T, Matulonis UA, et al. Relacorilant + nab- Biontech; and a leadership role as Chair of the Alleanza Contro il paclitaxel in patients with recurrent, platinum-resistant ovarian Tumore Ovarico Scientific Committee, and a member of the nomination cancer: a three-arm, randomized, controlled, open-label phase II study. J Clin Oncol 2023; 41: 4779–89. committee at ESMO. All other authors declare no competing interests. 12 Olawaiye AB, Gladieff L, O’Malley DM, et al. Relacorilant and Data sharing nab-paclitaxel in patients with platinum-resistant ovarian cancer De-identified datasets for the results reported in this publication can be (ROSELLA): an open-label, randomised, controlled, phase 3 trial. made available to qualified researchers following submission of a Lancet 2025; 405: 2205–16. methodologically sound proposal to datarequests@corcept.com. Data 13 Custodio JM, Donaldson KM, Hunt HJ. An in vitro and in vivo will be made available for such requests following the online publication evaluation of the effect of relacorilant on the activity of of the Article and for 1 year thereafter in compliance with applicable cytochrome P450 drug metabolizing enzymes. J Clin Pharmacol privacy laws, data protection, and requirements for consent and 2021; 61: 244–53. anonymisation. Data will be provided by Corcept Therapeutics. 14 Colombo N, Botbyl J, Kesner-Hays A, et al. Relacorilant + nab-paclitaxel vs nab-paclitaxel in platinum-resistant ovarian Acknowledgments cancer: pharmacokinetics and pharmacokinetic/ We thank the patients, their caregivers and their families; the pharmacodynamic exposure-response. investigators, co-investigators, and devoted trial teams at each of the Int J Gynecol Cancer 2026; 36 (2 suppl 1): 103099 (abstr). participating centres. The Gynecologic Oncology Group Foundation, the 15 Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the European Network of Gynaecological Oncological Trial Groups, the Asia- significance of changes in health-related quality-of-life scores. Pacific Gynecologic Oncology Trials Group (the Australia New Zealand J Clin Oncol 1998; 16: 139–44. Gynaecological Oncology Group and the Korean group), and the Latin 16 Cocks K, King MT, Velikova G, et al. Evidence-based guidelines American Cooperative Oncology Group were instrumental in the design, for interpreting change scores for the European Organisation for conduct, and analysis of ROSELLA; we are grateful to their leadership the Research and Treatment of Cancer Quality of Life and investigators. We acknowledge with gratitude the contribution of Questionnaire Core 30. Eur J Cancer 2012; 48: 1713–21. Michael E McCollum who died before the publication of this Article. 17 Vergote I, Copeland LJ, Van Gorp T, et al. Tumor Treating Fields Michael E McCollum cared for patients enrolled in this study at Virgina therapy in platinum-resistant ovarian cancer: results of the ENGOT-ov50/GOG-3029/INNOVATE-3 pivotal phase 3 Oncology Associates, Norfolk, VA, USA. His scientific insight, clinical randomized study. Eur J Cancer 2025; 219: 115306. commitment, and collegiality were integral to this work. He earned 18 US Food and Drug Administration. 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J Clin Oncol 2023; 41: 4768–78. 1524 --- [PDF原文](https://sci-net.xyz/storage/7932541/6b27d3f1e2af7b58343d1321fe7804966fe7e08c4b66a15dd4b0306e4a5db07d/Overall-survival-with-relacorilant-and-nab-paclitaxel-in-patients-with-platinum-resistant.pdf) DOI: 10.1016/S0140-6736(26)00462-9