ESMO 2025 featured several important updates in gynaecological oncology. Among the highlights was the latest data from the ROSELLA trial (GOG3073, ENGOT-ov72, APGOT-OV10), evaluating relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer (PROC) previously exposed to a PARP inhibitor.
The study builds on the findings presented at ASCO 2025 earlier this year, where the combination showed encouraging results in this challenging patient population.
In this interview, we speak with Prof. Domenica Lorusso (Humanitas Hospital San Pio X, Humanitas University, Rozzano, Milan) about the latest ROSELLA findings, their implications for clinical practice, the next steps in this research and other key data presented at this year’s meeting.
Abstract reference: LBA45 – ROSELLA (GOG3073, ENGOT-ov72, APGOT-OV10): Relacorilant + nab-paclitaxel in the subgroup of patients with platinum-resistant ovarian cancer (PROC) previously exposed to a PARP inhibitor.
Q: Could you give us a little background on the ROSELLA trial and the data so far?
Certainly. Relacorilant is a novel, selective glucocorticoid receptor antagonist that, in preclinical and early clinical data, was shown to restore sensitivity of cancer to cytotoxic chemotherapy. In a randomized phase II trial, the combination of nab-paclitaxel with relacorilant suggested a trend toward improved overall survival compared with nab-paclitaxel alone.
The phase III ROSELLA trial confirmed these findings. It enrolled patients with platinum-resistant ovarian cancer who had received up to three prior lines of therapy, including bevacizumab. Patients were randomized to receive nab-paclitaxel alone or in combination with relacorilant.
The primary endpoint, progression-free survival (PFS), was met with a hazard ratio of 0.70. Median PFS was significantly longer with the addition of relacorilant. An interim analysis of overall survival (OS), at 50% maturity, showed a positive trend with a hazard ratio of 0.69, equating to a 4.5-month improvement in OS.
Q: Could you summarize the results presented at ESMO in the subgroup of patients previously treated with PARP inhibitors?
About 61% of patients in Rosella had prior exposure to a PARP inhibitor, and 78% had disease progression during PARP inhibitor treatment, so this was a particularly challenging population.
In this group, relacorilant significantly improved PFS, with a hazard ratio of 0.60 and median PFS of 7.36 months compared with 4.63 months for nab-paclitaxel alone. Importantly, in patients progressing on a PARP inhibitor, the hazard ratio was 0.56. At the interim OS analysis, we also saw a trend toward improved survival with relacorilant in this subgroup (HR 0.77).
Q: What are the next steps for ROSELLA?
We are awaiting the final OS data, which will mature in Q1 2026 and be presented next year. If the current trend is confirmed, this combination could offer an important new option for platinum-resistant ovarian cancer. In parallel, the phase II BELLA trial is ongoing to evaluate relacorilant plus nab-paclitaxel in combination with bevacizumab. BELLA includes both bevacizumab-pretreated and bevacizumab-naïve cohorts, and recruitment is progressing quickly.
Q: Finally, beyond ROSELLA, were there any other highlights from recent meetings in the gynaecological cancer space?
We saw the final OS results of DUO-O (durvalumab plus olaparib in frontline ovarian cancer), which unfortunately did not show an OS benefit despite a positive PFS outcome. ICON8 also reported final OS data on weekly paclitaxel in frontline treatment. While not statistically significant, there was a 10-month OS increase in the weekly paclitaxel arm.1
Importantly, the ENGOT-ov65/KEYNOTE-B96 trial was the first positive study of immunotherapy in ovarian cancer, showing improved PFS and OS with weekly paclitaxel plus or minus bevacizumab and pembrolizumab, particularly in PD-L1–positive tumours.2
In endometrial cancer, the ACT trial of atezolizumab with carboplatin/paclitaxel was negative for OS.3 In cervical cancer, we saw interesting results from a chemo-free regimen combining a TKI with anti–PD-1 therapy, which improved PFS and OS compared with standard platinum–paclitaxel–bevacizumab. However, because immunotherapy was not included in the control arm, interpretation is challenging.4
Abstracts:
- LBA44 – Durvalumab + paclitaxel/carboplatin + bevacizumab followed by durvalumab, bevacizumab + olaparib maintenance in patients with newly diagnosed non-tBRCA-mutated advanced ovarian cancer: Final overall survival from DUO-O/ENGOT-ov46/GOG-3025
- LBA3 – Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind phase III ENGOT-ov65/KEYNOTE-B96 study
- LBA39 – Final overall survival (OS) results from the randomized double-blind phase III AtTEnd/ENGOT-EN7 trial evaluating atezolizumab in combination with paclitaxel and carboplatin in women with advanced/recurrent endometrial cancer
- LBA38 – Phase III study of camrelizumab plus famitinib versus platinum-based chemotherapy as first-line therapy for recurrent or metastatic cervical cancer
Disclosures: Domenica Lorusso is a consultant for MSD, GSK, Novartis; she has received grant/research support from Astra Zeneca, Clovis Oncology, Pharmaand Genmab, GSK, immunogen, Incyte, MSD, Novartis, Pharmamar, Roche, Seagen, alkermes and corcept; she is a member of the Advisory Board for Astra Zeneca, clovis oncology, corcept, daiichi sankyo, genmab, gsk, immunogen, msd, abbvie, novartis oncoinvest, novocure, seagen and sutro; she is a Speaker’s Bureau participant with Astra Zeneca, clovis oncology, corcept, daiichi sankyo, genmab, gsk, immunogen, msd, abbvie, novartis oncoinvest, novocure, seagen and sutro.
Interviewer: Nicola Cartridge, Head of Content.
Cite: ESMO25 Late Breaker: Relacorilant plus nab-paclitaxel shows promise in platinum-resistant ovarian cancer. touchONCOLOGY. November 13th, 2025
This content has been developed independently by Touch Medical Media for touchONCOLOGY. It is not affiliated with the European Society for Medical Oncology (ESMO). Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media.
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