Relacorilant Plus Nab-Paclitaxel May Improve Over Survival in Ovarian Cancer

A survival benefit was observed in patients with recurrent, platinum-resistant ovarian cancer who were treated with relacorilant (CORT-125134) plus nab-paclitaxel, according to phase 2 results announced in a press release from Corcept Therapeutics.

Patients treated with intermittent relacorilant plus nab-paclitaxel experienced a median overall survival (OS) of 13.9 months compared with 12.2 months for those receiving nab-paclitaxel. Those who received relacorilant the day before and after nab-paclitaxel experienced a 33% reduction in the risk of death vs nab-paclitaxel alone (HR, 0.67; 95% CI, 0.43-1.03; P = .066).

“Corcept has introduced a novel oncologic therapeutic platform, cortisol modulation. These results constitute a potentially important medical advance. 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,” Thomas Herzog, MD, deputy director at 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, said in the press release.

A total of 178 patients were enrolled and randomized 1:1:1 and received either nab-paclitaxel and 150 mg of relacorilant administered the day before, after, or weekly, known as the intermittent arm; nab-paclitaxel plus 100 mg of relacorilant administered daily, known as the continuous arm; or nab-paclitaxel alone, known as the comparator arm.

The median progression-free survival (PFS) was 5.6 months vs 3.8 months (HR, 0.66; 95% CI, 0.44-0.98; P = .038), and the median duration of response (DOR) was 5.6 months vs 3.7 months (HR, 0.36; 95% CI, 0.16-0.77; P = .006) in the intermittent vs comparator arms, respectively.

After excluding patients with primary platinum-refractory disease who had received 4 or more lines of therapy, the median PFS was 5.6 months vs 3.8 months (HR, 0.58; 95% CI, 0.37-0.91; P = .016), the median DOR was 5.6 months vs 3.6 months (HR, 0.26; 95% CI, 0.11-0.62; P = .001), and the median OS was 13.9 months vs 12.2 months (HR, 0.52; 95% CI, 0.31-0.86; P = .010).

Investigators assessed OS after a pre-determined number of deaths occurred. At the time of data cut off, 128 patients of 178 had died. Additionally, 14 patients in the intermittent arm, and 9 additional in the comparator arm are expected to contribute to the final OS results. One patient in the intermittent arm and 1 in the continuous arm have not experienced tumor progression and have been on treatment for over 20 months.

“We are excited to receive these survival data, which have continued to improve as the trial has progressed. If our phase 3 trial replicates the results in [PFS], [DOR], and [OS] that we’ve seen in phase 2, it will be an unprecedented success for patients with ovarian cancer. No approved therapy has been shown to significantly extend survival compared [with] standard chemotherapy in women with platinum-resistant ovarian cancer. We plan to meet with the FDA as soon as possible to define the best path forward and to open our phase 3 trial in the second quarter of 2022,” Bill Guyer, PharmD, chief development officer at Corcept, concluded.

Reference

Relacorilant plus nab-paclitaxel extends survival in women with recurrent, platinum-resistant ovarian cancer. News Release. Corcept Therapeutics. March 30, 2022. Accessed April 1, 2022. https://bit.ly/3DuVTUY