Encouraging results of relacorilant in ovarian cancer

The glucocorticoid receptor modulator relacorilant added to nab-paclitaxel demonstrated an overall survival (OS) benefit over nab-paclitaxel alone in patients with platinum-resistant/refractory ovarian cancer. These results provide evidence that cortisol modulation is a promising novel modality in oncology.

A phase 2 study randomised 178 patients with recurrent platinum-resistant ovarian cancer to intermittent relacorilant plus nab-paclitaxel, continuous relacorilant plus nab-paclitaxel, or nab-paclitaxel alone. The primary analysis showed a significantly improved median progression-free survival (PFS) for patients in the intermittent arm compared with the nab-paclitaxel alone arm (5.55 vs 3.76 months; HR 0.66; log-rank P=0.038). Prof. Nicoletta Colombo (University of Milan, Italy) presented the final results of the study, including mature OS results [1].

The updated PFS rates were similar with those of the primary analysis, with a median PFS of 5.6 months in the intermittent arm and a median PFS of 3.8 months in the control arm (HR 0.66; P=0.038). Prof. Colombo mentioned that the overall response rates were similar in the 2 arms, but that the duration of response was significantly longer in the intermittent arm (HR 0.36; P=0.006). Importantly, the trend towards an improved OS in the intermittent arm compared with the control arm that was observed in the primary analysis was maintained in this analysis, with a median OS of 13.9 versus 12.2 months (HR 0.67; P=0.066; see Figure). At 24 months, 27% and 14% of the patients were still alive in the intermittent and control arm, respectively. This result was consistent when patients with primary platinum-refractory disease were excluded from the analysis (HR 0.63; P=0.045). Finally, the updated safety analysis demonstrated that intermittent relacorilant does not come with additional safety issues compared to nab-paclitaxel alone.

Figure: Positive overall survival for intermittent relacorilant plus nab-paclitaxel [1]



OS, overall survival; mo, months; no., number; N/A, not applicable; Intermittent, intermittent relacorilant + nab-paclitaxel; Comparator, nab-paclitaxel monotherapy.

The promising results of relacorilant in this phase 2 study initiated the development of the phase 3 ROSELLA trial to assess this agent in patients with ovarian cancer.

1. Colombo N, et al. Overall survival data from a 3-arm, randomized, open-label, phase 2 study of relacorilant, a selective glucocorticoid receptor modulator, combined with nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer. LBA5503, ASCO 2022 Annual Meeting, 3–7 June, Chicago, IL, USA.

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Posted on 5 August 202217 May 2024