Inhibrx reports positive topline results from registrational trial of ozekibart

Inhibrx (INBX) Biosciences announced positive topline results from the registrational ChonDRAgon study investigating ozekibart as a single agent versus placebo in patients with advanced or metastatic, unresectable chondrosarcoma. The company also provided updates on the ongoing expansion cohorts investigating ozekibart in combination with FOLFIRI in late-line colorectal cancer and in combination with irinotecan and temozolomide in refractory Ewing sarcoma. The ChonDRAgon study met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival for patients with advanced or metastatic chondrosarcoma treated with ozekibart vs. placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo, more than doubling median PFS to 5.52 months versus 2.66 months for placebo. Ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a randomized trial for chondrosarcoma, a disease with no approved systemic options. Other key secondary endpoints, including disease control rate, and delay to deterioration in pain and physical function, further supported the clinical benefit observed with ozekibart. Ozekibart was generally well tolerated, with a manageable safety profile. One hepatotoxicity-related fatal event occurred early in the study, prior to the implementation of mitigation measures. Results from the Phase 1 trial of ozekibart in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal cancer show a 23% overall response rate and an overall disease control rate of 92%. The Phase 1 trial of ozekibart in combination with irinotecan and temozolomide (IRI/TMZ) for advanced or metastatic, unresectable, relapsed, or refractory Ewing sarcoma showed a 64% overall response rate, and a disease control rate of 92%, with the majority of patients experiencing measurable tumor reduction.