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The addition of relacorilant to nab-paclitaxel improved overall survival compared with nab-paclitaxel alone in patients with recurrent, platinum-resistant ovarian cancer.
The addition of relacorilant to nab-paclitaxel (Abraxane) improved overall survival (OS) compared with nab-paclitaxel alone in patients with recurrent, platinum-resistant ovarian cancer, according to findings from a phase 2 trial (NCT03776812).1
When relacorilant was given to patients the day prior to, the day of, and the day after their regular nab-paclitaxel infusions, it resulted in a 33% reduction in the risk of death vs those who just received nab-paclitaxel alone. The median OS in the investigative arm was 13.9 months (95% CI, 11.1-18.4) vs 12.2 months (95% CI, 7.7-15.3) in the control arm (HR, 0.67; 95% CI, 0.43-1.03; P = .066).
“Corcept [Therapeutics] has introduced a novel oncologic therapeutic platform, cortisol modulation. These results constitute a potentially important medical advance,” Thomas Herzog, MD, deputy director of the University of Cincinnati Cancer Center, member of the Board of Directors of the Gynecologic Oncology Group (GOG) Foundation, and associate director of GOG Partners, stated in a press release.
The randomized, controlled, phase 2 trial enrolled patients who had a histologic diagnosis of high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer or ovarian adenocarcinoma.2 Patients needed to be at least 18 years of age, have an ECOG performance status of 0 or 1, and acceptable organ and bone marrow function.
Patients must have experienced disease progression on prior lines of treatment, although they could not have received more than 4 previous chemotherapeutic or myelosuppressive regimens. Those with primary-refractory cancer could not have previously received more than 2 lines of treatment for refractory disease.
A total of 178 patients were randomized 1:1:1 to receive relacorilant administered at 150 mg the day before, the day of, and the day after each weekly nab-paclitaxel infusion (intermittent arm), nab-paclitaxel plus relacorilant given at a daily dose of 100 mg (continuous arm), or nab-paclitaxel alone (control arm).
The primary end point of the trial was progression-free survival (PFS), and secondary end points included objective response rate (ORR), duration of response (DOR), best overall response (BOR), 12-month PFS rate, PFS and BOR in those who crossed over to receive continuous treatment at the time of disease progression, CA-125 response, and OS.
At the time of database cutoff, 128 of the 178 patients enrolled had died. Fourteen additional patients in the intermittent-dosing arm and 9 additional patients in the control arm are expected to contribute to the final OS data. One woman in the intermittent-dosing arm and 1 in the continuous-dosing arm have not yet experienced progressive disease, and it has been over 20 months since they started treatment with relacorilant.
Additional data indicated that the median PFS was significantly improved in the intermittent-dosing arm at 5.6 months vs 3.8 months in the control arm (HR, 0.66; 95% CI, 0.44-0.98). The median DORs in the intermittent and control arms were 5.6 months and 3.7 months, respectively (HR, 0.36; 95% CI, 0.16-0.77; P = .0006).
Notably, the study population received a median of 3 prior lines of treatment. Additionally, more patients with either primary platinum-refractory disease or who had already received 4 or more prior lines of treatment had been assigned to the intermittent-dosing arm.
When excluding those with primary platinum-refractory disease and those who previously received 4 or more lines of therapy, intermittent relacorilant plus nab-paclitaxel resulted in a 48% reduction in the risk of death vs nab-paclitaxel alone. The median OS with the addition of relacorilant was 13.9 months (95% CI, 11.1-18.4) vs 12.2 months (95% CI, 7.7-15.3) with nab-paclitaxel alone (HR, 0.52; 95% CI, 0.31-0.86; P = .010).
The median PFS in the intermittent arm was 5.6 months vs 3.8 months in the control arm (HR, 0.58; 95% CI, 0.37-0.91; P = .016). The median DORs in the intermittent and control arms were 5.6 months and 3.6 months, respectively (HR, 0.26; 95% CI, 0.11-0.62; P = .001).
“In this large, randomized study, women with recurrent, platinum-resistant ovarian cancer who were administered relacorilant at the time they received nab-paclitaxel exhibited meaningful improvements in progression-free survival, duration of response, and OS – without increased [adverse] effects – compared with women who received nab-paclitaxel alone,” Herzog added. “For this patient population, relacorilant plus nab-paclitaxel has the potential to become a new standard of care.”