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

BACKGROUND: Relacorilant is a selective glucocorticoid receptor antagonist that increases the sensitivity of many cancer cell types to chemotherapy. The efficacy and safety of relacorilant plus nab-paclitaxel were assessed in the phase 3 ROSELLA (GOG-3073, ENGOT-ov72, APGOT-Ov10, and LACOG-0223) trial; the combination showed significant improvement in progression-free survival among patients with platinum-resistant ovarian cancer compared with nab-paclitaxel monotherapy. Results of the final overall survival analysis are reported here. METHODS: intravenously on the aforementioned schedule). Patients, aged 18 years or older, with one to three lines of previous anticancer therapy and platinum-resistant disease (progression <6 months from their last dose of platinum) were eligible. The trial was conducted at 117 hospitals and community oncology centres in 14 countries across Australia, Europe, Latin America, North America, and South Korea. Progression-free survival, assessed by blinded independent central review, and overall survival (time from randomisation to death from any cause) were dual primary endpoints. Additional prespecified endpoints included safety, second progression-free survival (time from randomisation to disease progression on subsequent anticancer therapy or death due to any cause, whichever occurred first), and patient-reported outcomes. This trial is registered at ClinicalTrials.gov, NCT05257408, and is ongoing. FINDINGS: Between Jan 5, 2023, and April 8, 2024, 381 patients were randomly assigned to the relacorilant combination group (n=188) or the nab-paclitaxel monotherapy group (n=193). All patients had received bevacizumab; 167 (44%) had received three previous lines of therapy, and 234 (61%) had received a poly(ADP-ribose) polymerase inhibitor. At a median follow-up of 24·8 months (95% CI 23·6-25·7), the addition of relacorilant to nab-paclitaxel resulted in a statistically and clinically significant improvement in overall survival compared with nab-paclitaxel monotherapy (hazard ratio for death 0·65 [95% CI 0·51-0·83]; p=0·0004); 18-month overall survival was 46% and 27%, respectively. The median overall survival in the relacorilant combination group was extended by 4·1 months compared with the nab-paclitaxel monotherapy group (16·0 [95% CI 13·0-18·3] vs 11·9 months [10·0-13·8]). Subsequent anticancer treatments were similar across study groups. Adverse events were similar in both groups when adjusted for duration of study treatment. Neutropenia (121 [64%]), anaemia (115 [61%]), fatigue (101 [54%]), and nausea (82 [44%]) were the most common adverse events in the relacorilant combination group. No new safety signals were observed with additional follow-up since the primary analysis. INTERPRETATION: The addition of relacorilant to nab-paclitaxel led to significantly longer overall survival in patients with platinum-resistant ovarian cancer, without the need for biomarker selection. The findings support relacorilant plus nab-paclitaxel as a potential new standard treatment option for patients with platinum-resistant ovarian cancer. FUNDING: Corcept Therapeutics.

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Journal
The Lancet
Published
2026-04-01
DOI
https://doi.org/10.1016/s0140-6736(26)00462-9
Citations
1
Primary Topic
Ovarian cancer diagnosis and treatment
Type
article
Field-Weighted Citation Impact
24.34

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article

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

Maria Chiara Cannizzaro, Grazia Artioli, Mariana Scaranti, Adrian M. Jubb et al.
1 citations
The Lancet
Ovarian cancer diagnosis and treatment
24.34
article

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

Maria Chiara Cannizzaro, Grazia Artioli, Mariana Scaranti, Adrian M. Jubb, Alix Devaux, Ana Santaballa, Andrea Bagaméri, Giuseppa Scandurra, Connie I. Diakos, Iulia Cristina Tudor, Aliza Leiser, Stanislas Quesada, Chiara Cassani, Linda Mileshkin, Lyndah Dreiling, Toon Van Gorp, Christina Prillaman, Laurène Gavoille, Gabriel Garbaos, Yong Jae Lee, C. McClung, Elizabeth Hopp, Amanda Kesner-Hays, Domenica Lorusso, Elena Giudice, Vittoria Carbone, Anna Fagotti, Philippe Follana, Lucy Gilbert, David M O'Malley, Vanda Salutari, Alexander B Olawaiye, Ana Oaknin, Andrew Clamp, Laurence Gladieff, Brian Slomovitz, Nicoletta Colombo, Paolo Scollo, Byoung-Gie Kim, Jae-Weon Kim, Bradley J Monk
article en
1 citations

Abstract

BACKGROUND: Relacorilant is a selective glucocorticoid receptor antagonist that increases the sensitivity of many cancer cell types to chemotherapy. The efficacy and safety of relacorilant plus nab-paclitaxel were assessed in the phase 3 ROSELLA (GOG-3073, ENGOT-ov72, APGOT-Ov10, and LACOG-0223) trial; the combination showed significant improvement in progression-free survival among patients with platinum-resistant ovarian cancer compared with nab-paclitaxel monotherapy. Results of the final overall survival analysis are reported here. METHODS: intravenously on the aforementioned schedule). Patients, aged 18 years or older, with one to three lines of previous anticancer therapy and platinum-resistant disease (progression <6 months from their last dose of platinum) were eligible. The trial was conducted at 117 hospitals and community oncology centres in 14 countries across Australia, Europe, Latin America, North America, and South Korea. Progression-free survival, assessed by blinded independent central review, and overall survival (time from randomisation to death from any cause) were dual primary endpoints. Additional prespecified endpoints included safety, second progression-free survival (time from randomisation to disease progression on subsequent anticancer therapy or death due to any cause, whichever occurred first), and patient-reported outcomes. This trial is registered at ClinicalTrials.gov, NCT05257408, and is ongoing. FINDINGS: Between Jan 5, 2023, and April 8, 2024, 381 patients were randomly assigned to the relacorilant combination group (n=188) or the nab-paclitaxel monotherapy group (n=193). All patients had received bevacizumab; 167 (44%) had received three previous lines of therapy, and 234 (61%) had received a poly(ADP-ribose) polymerase inhibitor. At a median follow-up of 24·8 months (95% CI 23·6-25·7), the addition of relacorilant to nab-paclitaxel resulted in a statistically and clinically significant improvement in overall survival compared with nab-paclitaxel monotherapy (hazard ratio for death 0·65 [95% CI 0·51-0·83]; p=0·0004); 18-month overall survival was 46% and 27%, respectively. The median overall survival in the relacorilant combination group was extended by 4·1 months compared with the nab-paclitaxel monotherapy group (16·0 [95% CI 13·0-18·3] vs 11·9 months [10·0-13·8]). Subsequent anticancer treatments were similar across study groups. Adverse events were similar in both groups when adjusted for duration of study treatment. Neutropenia (121 [64%]), anaemia (115 [61%]), fatigue (101 [54%]), and nausea (82 [44%]) were the most common adverse events in the relacorilant combination group. No new safety signals were observed with additional follow-up since the primary analysis. INTERPRETATION: The addition of relacorilant to nab-paclitaxel led to significantly longer overall survival in patients with platinum-resistant ovarian cancer, without the need for biomarker selection. The findings support relacorilant plus nab-paclitaxel as a potential new standard treatment option for patients with platinum-resistant ovarian cancer. FUNDING: Corcept Therapeutics.

The LancetVol. 407(10538)
Rutgers, The State University of New Jersey (US), Humanitas University (IT), Seoul National University (KR), Palo Alto University (US), Yonsei University (KR), Medical College of Wisconsin (US), Università degli Studi di Enna Kore (IT), University of Pavia (IT), The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (US), Royal North Shore Hospital (AU), Peter MacCallum Cancer Centre (AU), McGill University Health Centre (CA), Samsung Medical Center (KR), Agostino Gemelli University Polyclinic (IT), Hospital Universitari i Politècnic La Fe (ES), Virginia Oncology Associates (US), The European Academy of Gynaecological Surgery (BE), Manchester University NHS Foundation Trust (GB), Mount Sinai Medical Center (US), AULSS 2 Marca Trevigiana (IT), Hospital Universitario Puerta de Hierro Majadahonda (ES), Magee-Womens Hospital (US), Imagerie Adaptative Diagnostique et Interventionnelle (FR), Florida Cancer Specialists & Research Institute (US), National Institute of Oncology (HU), Institut Claudius Regaud (FR), Corcept Therapeutics (United States) (US), The Christie NHS Foundation Trust (GB), Ospedale Cannizzaro (IT), Institut de Recherche en Cancérologie de Montpellier (FR), Hôpital Civil de Charleroi (BE), Fundación Centro de Estudios Infectológicos (AR), Centre Antoine Lacassagne (FR), Grand Charleroi Hospital (BE), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Hospital São Paulo (BR), Instituto de Investigación Sanitaria La Fe (ES), Rutgers Cancer Institute (US), The Ohio State University (US), European Institute of Oncology (IT), Sungkyunkwan University (KR), Stanford University (US), KU Leuven (BE)
Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Gilead Sciences, Regeneron Pharmaceuticals, Exelixis, Novocure, Clovis Oncology, Deciphera Pharmaceuticals, Mersana Therapeutics, Myriad Genetics, Incyte, Verastem Oncology, MacroGenics, Seagen, Natera, Eisai, European Society for Medical Oncology, Servier, PharmaMar, Genentech, Daiichi Sankyo Europe
Good health and well-being
Openalex Percentile: Top 1%
Ovarian cancer diagnosis and treatment
24.34
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