Intermittent relacorilant with nab-paclitaxel prolongs survival in recurrent platinum-resistant ovarian cancer
A survival benefit was demonstrated in a phase 2 study using intermittent relacorilant and nab-paclitaxel for the treatment of patients with recurrent platinum-resistant ovarian cancer.
The combination of intermittent relacorilant (CORT-125134) and nab-paclitaxel (Abraxane) provided a 33% reduction in the risk of death compared to nab-paclitaxel alone in women with recurrent resistant ovarian cancer platinum, according to an announcement from Corcept Therapeutics, Inc.1
The median overall survival (OS) in the intermittent combination arm was 13.9 months (95% CI, 11.1-18.4) versus 12.2 months (95% CI, 7.7- 15.3) with nab-paclitaxel (HR, 0.67; 95% CI, 0.43-1.03; P = 0.066).
“Corcept has introduced a new oncology therapeutic platform, cortisol modulation. These results are a potentially significant medical advance,” said Thomas Herzog, MD, deputy director of the University of Cincinnati Cancer Center, board member of the Gynecologic Oncology Group (GOG) Foundation, and associate director of GOG Partners. “In this large randomized study, women with recurrent platinum-resistant ovarian cancer who received relacorilant at the same time as they received nab-paclitaxel showed significant improvements in progression-free survival. [PFS]duration of response [DOR], and overall survival – without increased side effects – compared to women who received nab-paclitaxel alone. For this patient population, relacorilant in combination with nab-paclitaxel has the potential to become a new standard of care. »
In the phase 2, open-label, multicenter, randomized, 3-arm study (NCT03776812), 178 patients with recurrent platinum-resistant ovarian cancer were included. The primary endpoint assessed in the study was PFS, and secondary endpoints include objective response rate (ORR), DOR, response according to gynecologic cancer intergroup criteria, best rate overall response rate, PFS rate, PFS in crossover population, ORR in crossover population, DOR in crossover population, best overall response in crossover population, CA-125 response, OS and combined answer according to RECISTS v1.1.
Study patients are allocated in a 1:1:1 ratio to receive oral relacorilant 100 mg once daily in combination with nab-paclitaxel 80 mg/m2, oral relacorilant 150 mg plus nab-paclitaxel 80 mg/m2, both compared to nab-paclitaxel 100 mg/m2 arm.
Enrollees in the study were women aged 18 years or older with a histological diagnosis of high-grade serous or endometrioid epithelial cancer of the ovary, primary peritoneum, or fallopian tubes or ovarian carcinosarcoma. The study excluded people with clear cell, mucinous, and borderline histological subtypes. Patients were required to have received at least 1 line of therapy with evidence of cancer progression within 6 months of the last dose of platinum therapy.
Patients must also have had disease measurable by RECIST 1.1, an ECOG performance status of 0 or 1, and adequate organ and bone marrow function. The study is active but no longer recruiting patients.2
“We are excited to receive this survival data, which has continued to improve as the trial progressed,” said Bill Guyer, PharmD, chief development officer, Corcep, in the press release.1 “If our phase 3 trial replicates the results in progression-free survival, duration of response and overall survival that we saw in phase 2, it will be an unprecedented success for patients with prostate cancer. ovary.No approved treatment has been shown to significantly prolong survival over standard chemotherapy in women with platinum-resistant ovarian cancer.We plan to meet with the FDA as soon as possible to define the best way forward and open our phase 3 trial in the second quarter of 2022.”
1. Relacorilant plus nab-paclitaxel prolongs survival in women with recurrent platinum-resistant ovarian cancer. Press release. Corcept Therapeutics, Inc. March 30, 2022. Accessed April 1, 2022. https://bit.ly/3uKjYDn
2. Study of relacorilant in combination with nab-paclitaxel in patients with recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneum cancer. Clinicaltrials.gov. Updated June 8, 2021. Accessed April 1, 2022. https://bit.ly/3K2OVce