Overview
Corcept Therapeutics saw its stock surge roughly 40% on Wednesday following the FDA approval of relacorilant, marketed as Lifyorli, when used together with nab-paclitaxel for adults diagnosed with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The regulatory clearance applies to patients who have undergone one to three prior systemic treatment regimens, and it requires that at least one of those prior regimens included bevacizumab. The FDA completed its review 2.5 months earlier than its scheduled goal date.
Clinical evidence
The approval was grounded in data from the ROSELLA trial, a multicenter study that enrolled 381 patients with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Participants were randomized to receive either the combination of relacorilant plus nab-paclitaxel or nab-paclitaxel alone. In the trial, the combination therapy achieved a median progression-free survival of 6.5 months compared with 5.5 months for nab-paclitaxel by itself. Overall survival in the study was reported at 16 months for patients receiving the combination versus 11.9 months for those on the single agent.
Mechanism, dosing, and administration
Relacorilant is classified as a glucocorticoid receptor antagonist. The prescribing information specifies a relacorilant dose of 150 mg taken orally once daily for three consecutive days around each nab-paclitaxel infusion. Nab-paclitaxel administration in the approved regimen is 80 mg/m2 delivered intravenously on days 1, 8, and 15 of each 28-day cycle.
Safety and contraindications
The prescribing information includes a contraindication for patients who require corticosteroids for life-saving indications. Reported common adverse reactions associated with the regimen include decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.
Market reaction
The FDA decision and the underlying ROSELLA trial results prompted a sharp move in Corcept Therapeutics' share price on the announcement day, reflecting investor response to the regulatory clearance and the clinical outcomes presented in the study.