Dr Salutari on the Rationale for Evaluating Relacorilant Plus Nab-Paclitaxel in PARP Inhibitor–Treated PROC

“There is a large unmet need in the platinum-resistant population. The pathway of corticosteroids has been shown to be very important in [patients with] platinum-resistant ovarian cancer. Cortisol has been shown [to play] an important role in disease metastasis and progression.”

Vanda Salutari, MD, an oncologist in the Department of Health of Woman and Child at the Catholic University of Sacred Heart, discussed the rationale for the phase 3 ROSELLA study (NCT05257408).

ROSELLA enrolled patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer who received prior bevacizumab (Avastin) and who experienced disease progression after at least 1 month but no more than 6 months after their last dose of platinum-based chemotherapy. Other key inclusion criteria included having received 1 to 3 prior lines of therapy and an ECOG performance status of 0 or 1.

Patients were randomly assigned 1:1 to receive the novel selective glucocorticoid receptor antagonist relacorilant in combination with nab-paclitaxel (Abraxane) or nab-paclitaxel alone. In the investigational arm, relacorilant was administered at 150 mg orally and intravenous (IV) nab-paclitaxel was given at a dose of 80 mg/m2. Patients in the control arm received IV nab-paclitaxel at 100 mg/m2. Treatment in both arms continued until disease progression or unacceptable toxicity occurred.

The primary end point of ROSELLA was progression-free survival (PFS) per RECIST 1.1 criteria assessed by blinded independent central review and overall survival. Secondary end points included investigator-assessed PFS per RECIST 1.1 criteria and safety.

Salutari noted that there is a large unmet need for patients with platinum-resistant ovarian cancer (PROC). The glucocorticoid pathway represents an attractive treatment target for patients with PROC because cortisol has been shown can contribute to disease progression, she added. Targeting this pathway with an agent such as relacorilant could help to overcome platinum resistance in these patients, she concluded.