Corcept Therapeutics presents final overall survival data from ROSELLA trial

Corcept Therapeutics (CORT) presented final overall survival data from its pivotal Phase 3 ROSELLA trial of Lifyorli combined with the chemotherapeutic agent nab-paclitaxel in patients with platinum-resistant ovarian cancer in a late-breaking oral presentation at the Society of Gynecologic Oncology annual Meeting on Women’s Cancer. These data were simultaneously published in The Lancet. Lifyorli plus nab-paclitaxel has now been added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a preferred regimen for patients with platinum-resistant ovarian cancer. Lifyorli, in combination with nab-paclitaxel, was approved by the FDA in March for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. The ROSELLA trial met its dual primary endpoints of overall and progression-free survival, regardless of biomarker status and without an increased safety burden. Patients treated with Lifyorli in addition to nab-paclitaxel chemotherapy experienced a 35% reduction in the risk of death compared to patients treated with nab-paclitaxel alone. Median overall survival was 4.1 months longer for patients who received Lifyorli, compared to patients receiving nab-paclitaxel alone. Patients who received Lifyorli in addition to nab-paclitaxel also experienced a 30% reduction in the risk of disease progression, as assessed by blinded independent central review compared to patients treated with nab-paclitaxel alone. The combination of Lifyorli with nab-paclitaxel was well-tolerated. Adverse events in the combination arm were comparable to those in the nab-paclitaxel monotherapy arm. The prescribing information for Lifyorli includes 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 experienced by more than 20% of patients were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.