Clinical Summary:

• Design/Population: The phase 3 ROSELLA trial was an open-label, randomized study comparing nab-paclitaxel plus relacorilant versus nab-paclitaxel alone in 381 patients with platinum-resistant recurrent ovarian cancer. 
• Key Outcomes: The addition of relacorilant resulted in a 30% improvement in progression-free survival and a 35% reduction in the risk of death, translating to a 4.1-month improvement in overall survival. Toxicity was generally comparable between treatment arms, with slightly higher rates of neutropenia and anemia in the relacorilant arm, likely related to longer treatment exposure.
• Clinical Relevance: These findings demonstrate clinically meaningful improvements in both progression-free and overall survival in a difficult-to-treat platinum-resistant ovarian cancer population. 

Lucy Gilbert, MD, MSc, Chair of Oncology at McGill University and Chief of Gynecological Oncology at the McGill University Health Centre, discusses findings from the phase 3 ROSELLA trial evaluating relacorilant plus nab-paclitaxel versus nab-paclitaxel alone in patients with platinum-resistant recurrent ovarian cancer. 

The trial met its primary objectives, demonstrating a 30% improvement in progression-free survival and a 35% reduction in the risk of death with the addition of relacorilant, resulting in a 4.1-month improvement in overall survival. Toxicity and quality-of-life outcomes were generally comparable between treatment groups. According to Gilbert, these results are particularly encouraging given the heavily pretreated patient population and support relacorilant plus nab-paclitaxel as a promising treatment option for platinum-resistant ovarian cancer.

Dr Gilbert presented these findings at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

Transcript:

Hello, I’m Lucy Gilbert, Chair of Oncology at McGill University and Chief of Gynecological Oncology at the McGill University Health Centre. Today, I’ll be discussing the ROSELLA phase 3 clinical trial.

This was an open-label trial for patients who had platinum-resistant recurrent ovarian cancer. It compared nab-paclitaxel, the treatment associated with the best outcomes in this difficult-to-treat group, with nab-paclitaxel plus relacorilant. The outcomes assessed were progression-free survival, overall survival, and toxicity.

This trial was positive, which means a lot to practicing oncologists and to patients. I’ll go through the details of the trial. It was a large phase 3 trial that included 14 countries across North America, Europe, Australia, Korea, and Latin America. A total of 381 patients were randomized 1:1 between the 2 treatment arms.

The primary endpoints were progression-free survival and overall survival, along with the toxicity associated with any survival gains. Progression-free survival was assessed by blinded independent central review to make it absolutely objective.

To describe the treatment in each arm, you’ll be familiar with nab-paclitaxel. It was given weekly on days 1, 8, and 15 of a 28-day cycle. Relacorilant is an oral treatment and was given the day before nab-paclitaxel, the day of treatment, and the day after, following the same schedule as nab-paclitaxel administration.

In a nutshell, we were very pleased that there was a 30% improvement in progression-free survival, and we were gratified that there was a 35% reduction in the risk of death. It added 4.1 months to overall survival, and this is immensely encouraging for a difficult-to-treat patient population.

Importantly, almost half the patients, 44%, had more than 3 prior lines of chemotherapy. All were exposed to bevacizumab, and about 61% had prior PARP inhibitor treatment. Achieving this degree of reduction in the risk of death and improvement in overall survival in such a difficult-to-treat group is immensely encouraging.

Toxicity was comparable in both groups. One could say death is the ultimate toxicity, and patients value an improvement in overall survival, but we would like the gain in overall survival to be achieved with reasonable quality of life. This treatment did not reduce quality of life compared with the comparator arm of nab-paclitaxel.

The discontinuation rate, fatigue, gastrointestinal symptoms, and neuropathy were comparable between the groups. There was slightly more neutropenia and anemia. This is related to the duration of treatment because these patients were exposed to treatment, and therefore nab-paclitaxel, for a longer period. Relacorilant monotherapy has not been associated with increased neutropenia.

Higher rates of neutropenia in the intervention arm may be related to the longer duration of treatment and also the fact that, because relacorilant may encourage apoptosis, this may have contributed to increased myelosuppression.

Relacorilant monotherapy is associated with slight anemia because glucocorticoid receptors have an effect on erythropoietin, so this may have had an additive effect. The important point to make is that these toxicities are very manageable.

Source:

Gilbert L, You B, Olawaiye A, Choi CH, Scaranti M, Valabrega G, 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 (GOG-3073, ENGOT-ov72, APGOT-Ov10, LACOG-0223, and ANZGOG-2221/2023). Presented at the ASCO Annual Meeting. 2026. Abstract 5505.