FDA Approves New Drug Combo for Tough-to-Treat Ovarian Cancer

The FDA approved relacorilant (Lifyorli) in combination with nab-paclitaxel (Abraxane) for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The combination of the selective glucocorticoid receptor antagonist and chemotherapy drug is indicated for patients who have received one to three prior lines of therapy, at least one of which included bevacizumab (Avastin).

“Data demonstrate that Lifyorli plus nab-paclitaxel provides a clinically meaningful benefit in overall survival for patients with platinum-resistant ovarian cancer and is well tolerated. Lifyorli is positioned to become a new standard-of-care treatment,” said Rob Coleman, MD, of Texas Oncology in Houston, in a press release from drugmaker Corcept. “Having a new treatment for this advanced, recurrent disease will provide clinicians with a compelling option to help patients with this extremely difficult-to-treat cancer.”

Approval was based on results from the phase III ROSELLA trial, an international study that included 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. These patients had received up to three previous lines of anticancer therapy and previous bevacizumab, and had disease progression or intolerance to the most recent therapy.

Patients were randomized to receive relacorilant (150 mg orally the day before, of, and after nab-paclitaxel infusion) plus nab-paclitaxel (80 mg/m² intravenously on days 1, 8, and 15 of each 28-day cycle) or nab-paclitaxel monotherapy (100 mg/m² intravenously on the same schedule).

Median progression-free survival was 6.5 months in the relacorilant/nab-paclitaxel arm and 5.5 months in the nab-paclitaxel monotherapy arm (HR 0.70, 95% CI 0.54-0.91, P=0.0076), while median overall survival was 16 months and 11.9 months in the two arms, respectively (HR 0.65, 95% CI 0.51-0.83, P=0.0004).

Prescribing information for relacorilant includes a contraindication for patients who require corticosteroids for a lifesaving indication, as well as warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity.

The most common adverse reactions occurring in patients treated with relacorilant in combination with nab-paclitaxel were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.