Dr Lorusso on Key Takeaways About Relacorilant Combination Treatment in Ovarian Cancer

Domenica Lorusso, MD, PhD, director, Gynaecological Oncology Unit, Humanitas Hospital San Pio X, Milan; full professor, Obstetrics and Gynaecology, Humanitas University, discusses her key takeaways from a phase 2 trial (NCT03776812), which evaluated the selective glucocorticoid receptor modulator relacorilant (CORT125134) in combination with nab-paclitaxel (Abraxane) in patients with recurrent, platinum-resistant ovarian cancer.

Regarding the efficacy of continuous dosing of relacorilant observed in the phase 2 trial, the data indicated that this regimen was less effective compared with intermittent dosing, she begins. These phase 2 data will guide the direction of subsequent trials to optimize patient outcomes, she explains. Based on these findings, the decision was made to implement an intermittent dosing schedule for the randomized phase 3 ROSELLA trial (EudraCT 2022-000662-18).

In the ROSELLA trial, prophylactic measures to reduce the incidence of grade 3 or higher hematologic toxicities, which were noted in the phase 2 trial, were approached differently than in the phase 2 trial, Lorusso reports. Although the phase 2 trial mandated prophylaxis for all participants, the phase 3 trial provides more discretion to the investigating oncologists, according to Lorusso, offering more flexibility for managing hematologic toxicities. Lorusso states that in her experience enrolling patients on the ROSELLA trial, she has found that the hematologic toxicities associated with relacorilant plus nab-paclitaxel have been manageable without the routine use of granulocyte colony–stimulating factor. This demonstrates the potential for individualized approaches to managing toxicities that maintaining patient safety and treatment efficacy, she notes.

Looking forward to the continued development of relacorilant, this class of agents has many possibilities, Lorusso expands. The discovery of the cortisol pathway and its role in chemoresistance, particularly through the epithelial-mesenchymal transition, has provided a key insight, she says. Blocking this pathway offers a novel and promising strategy to improve patient outcomes by reducing chemoresistance, further advancing cancer treatment options, she concludes.