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Phase 3 ROSELLA data in platinum-resistant ovarian cancer

Investigators reported positive final overall survival findings for relacorilant plus nab-paclitaxel, with further study needed to determine sequencing with other agents.

  • Prof Domenica Lorusso, MD, Laurence Gladieff, MD, David M. O'Malley, MD, Prof Jae-Weon Kim, MD, Gabriel Garbao, MD, Prof Anna Fagotti, MD, et al.

  • April 10, 2026

  • The Lancet
  • 2026; 407, 1513-1524
  • 10.1016/S0140-6736(26)00462-9

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Evidence before this study

In a search of PubMed for articles published up to Jan 27, 2026, using the search terms “selective” AND “glucocorticoid receptor” AND (“cancer” or “carcinoma”) with no language restrictions, we found that data have been published on selective glucocorticoid receptor antagonism in ovarian cancer for only four clinical trials, three with the selective glucocorticoid receptor antagonist relacorilant and one with the less selective ORIC-101. The first trial (NCT02762981) was a phase 1/2 study to determine the recommended phase 2 dose of relacorilant plus nab-paclitaxel in patients with advanced solid tumours. The second and third trials (NCT03776812 and NCT05257408) were a randomised phase 2 study, and the primary results of the phase 3 study described herein, evaluating the combination of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer. The fourth trial (NCT03928314) was a phase 1 dose escalation and expansion study to determine the recommended phase 2 dose of ORIC-101 in combination with nab-paclitaxel in patients with advanced solid tumours.

Added value of this study

The positive results for final overall survival, a dual primary endpoint of the ROSELLA (GOG-3073, ENGOT-ov72, APGOT-Ov10, and LACOG-0223) study, confirm the previously reported data for the other dual primary endpoint, progression-free survival, and are consistent with the findings from the phase 2 study. In a patient population that is receiving single-agent chemotherapy with a median life expectancy of 1 year, overall survival results are the most impactful efficacy endpoint. This study provides a robust analysis that is mature, has considerable follow-up, was conducted per the prespecified statistical analysis plan, and is based on a complete dataset. In addition, positive data for second progression-free survival confirm that the treatment benefit of relacorilant provides durable disease control beyond first progression. The study also provides patient-reported outcome data and updated safety data to support a complete benefit–risk determination.

Implications of all the available evidence

Combined with the evidence from previous studies, these positive overall survival data support relacorilant plus nab-paclitaxel as a potential new standard treatment option for patients with platinum-resistant ovarian cancer, without the need for biomarker selection. This study is the first positive clinical trial conducted with registrational intent for a selective glucocorticoid receptor antagonist in patients with cancer. The data supports the ongoing evaluation of relacorilant in other solid tumour indications and in combination with other classes of anticancer agents. In the AURELIA trial, the VEGF inhibitor bevacizumab also extends progression-free survival in combination with chemotherapy in this setting but has not shown a statistically significant overall survival benefit—probably owing, in part, to crossover to the investigational group at progression—and is predominantly used in earlier lines of therapy for patients with ovarian cancer. Furthermore, mirvetuximab soravtansine has shown an overall survival benefit in a third of patients with high-grade serous folate receptor α–positive ovarian cancer. The addition of pembrolizumab to weekly paclitaxel (with or without bevacizumab) has reported an overall survival benefit in a less pre-treated population. Additional studies will be needed to determine the appropriate sequencing of these agents.

Source: The Lancet

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