Array Biopharma present Phase 3 COLUMBUS Part 2 results in BRAF-Mutant Melanoma
- Co announced results from Part 2 of the Phase 3 COLUMBUS study evaluating binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The primary analysis of Part 2 compared progression free survival in patients treated with binimetinib 45 mg twice daily plus encorafenib 300 mg daily to patients treated with encorafenib 300 mg daily as a single agent.
- The median PFS for patients treated with COMBO300 was 12.9 months compared to 9.2 months for patients treated with single agent encorafenib, with HR of 0.77
- Grade 3/4 adverse events (AEs) that occurred in 5% or more of patients receiving COMBO300 were increased gamma-glutamyltransferase (GGT) (5%), increased blood creatine phosphokinase (CK) (5%) and increased alanine aminotransferase (ALT) (5%).
- The incidence of selected any grade AEs of special interest, defined based on toxicities commonly associated with commercially available MEK+BRAF-inhibitor treatments for patients receiving COMBO300 included: pyrexia (17%), rash (15%), retinal pigment epithelial detachment (9%) and photosensitivity (2%).
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