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Inhibrx Biosciences Reports Positive Topline Results from its Registrational Trial of Ozekibart (INBRX-109) in Chondrosarcoma and Provides Updates on Colorectal Cancer and Ewing Sarcoma Expansion Cohorts
Prnewswireยท 2025-10-23 20:05
Core Insights - Inhibrx Biosciences announced positive topline results from the ChonDRAgon study, demonstrating the efficacy of ozekibart (INBRX-109) in treating advanced or metastatic chondrosarcoma, achieving a statistically significant improvement in median progression-free survival (PFS) compared to placebo [1][2][6] Chondrosarcoma Study Results - The ChonDRAgon study met its primary endpoint, showing a 52% reduction in the risk of disease progression or death with ozekibart, resulting in a median PFS of 5.52 months versus 2.66 months for placebo [2][6] - Ozekibart is the first investigational therapy to show a significant PFS benefit in a randomized trial for chondrosarcoma, a condition lacking approved systemic treatments [2][6] - Key secondary endpoints indicated a disease control rate of 54% for ozekibart compared to 27.5% for placebo, along with improvements in pain and physical function [3][6] Safety Profile - Ozekibart was generally well tolerated, with common treatment-related adverse events including fatigue, constipation, and nausea. The incidence of treatment-related hepatic adverse events was 11.8% compared to 4.5% in the placebo group [4][10] - Hepatotoxicity was managed effectively through patient selection and monitoring, resulting in a low overall incidence of severe liver-related adverse events [4][10] Expansion Cohorts - Inhibrx is conducting expansion cohorts for ozekibart in combination with FOLFIRI for colorectal cancer and with irinotecan and temozolomide for Ewing sarcoma, showing promising early results [6][15] - Initial results from the colorectal cancer trial indicated a 23% overall response rate and a 92% disease control rate in a heavily pretreated patient population [7][8] - For Ewing sarcoma, the combination therapy showed a 64% overall response rate and a 92% disease control rate among evaluable patients [9][10] Future Plans - The company plans to file a Biologics License Application (BLA) for ozekibart in Q2 of 2026, aiming to expedite its availability to patients [6][10] - Detailed results from the ChonDRAgon study will be presented at the Connective Tissue Oncology Society Annual Meeting on November 14, 2025 [5][6]