Combining relacorilant with nab-paclitaxel in a subset of patients with recurrent, platinum-resistant ovarian cancer appeared to improve overall survival (OS), according to research presented at the 2022 ASCO Annual Meeting.

Previous studies have demonstrated that cortisol plays a role in resistance to chemotherapy. Relacorilant, which selectively modulates the glucocorticoid receptor modulator, reverses the effects of cortisol, potentially restoring responses to chemotherapy.

A randomized phase 2 trial (ClinicalTrials.gov Identifier: NCT03776812) previously demonstrated that adding relacorilant to nab-paclitaxel improved progression-free survival, without extreme toxicity, in patients with platinum-resistant ovarian cancer. At ASCO 2022, Nicoletta Colombo, MD, of the University of Milan-Bicocca in Italy, presented OS data from the study.


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Overall, 178 patients with recurrent, platinum-resistant or refractory ovarian, primary peritoneal, or fallopian tube cancer, or ovarian carcinosarcoma, were enrolled. All patients had received 4 or fewer previous chemotherapy regimens.

The patients were randomly assigned to receive nab-paclitaxel with intermittent relacorilant (60 patients), nab-paclitaxel with continuous relacorilant (58 patients), or nab-paclitaxel alone (60 patients). In these 3 groups, 11 patients had disease that was primary refractory to platinum therapy.

The researchers found that intermittent relacorilant (hazard ratio [HR], 0.67; P =.066) and continuous relacorilant (HR, 0.85; P =.447) did not significantly improve OS over nab-paclitaxel alone. The intermittent group did, however, have a progression-free survival benefit over the comparator arm (HR, 0.66; P =.038).

Among patients without primary refractory disease, there was improved OS with intermittent relacorilant (HR, 0.63; P =.045) compared with nab-paclitaxel only (median OS, 13.9 vs 12.2 months, respectively). 

In the intermittent, continuous, and comparator arms, the most common grade 3 or higher adverse events for each group were anemia (13.3%), neutropenia (26.3%), and neutropenia (15%), respectively.

“The OS analysis confirmed the survival benefit of intermittent relacorilant, particularly in patients who were not primary platinum refractory,” Dr Colombo concluded.

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Colombo N, Van Gorp T, Matulonis UA, 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. Presented at ASCO 2022; June 3-7, 2022. Abstract LBA5503.