ozekibart (INBRX-109) in combination with FOLFIRI - (ChonDRAgon)

June 15, 2026: Inhibrx Biosciences, Inc. (NASDAQ: INBX) said the FDA accepted for filing its Biologics License Application (BLA) for ozekibart (INBRX-109) to treat patients with unresectable or metastatic conventional chondrosarcoma. The FDA identified no filing review issues and set a PDUFA goal date of April 14, 2027.

The BLA is supported by the ChonDRAgon study, a randomized, blinded, placebo-controlled registrational trial (n=206; 2:1 randomization; q3w dosing; RECIST 1.1 central independent review). The trial met its primary endpoint, showing a statistically significant progression-free survival (PFS) benefit for ozekibart vs placebo: hazard ratio 0.479 (95% CI 0.33–0.68), P<0.0001, with median PFS 5.52 months vs 2.66 months (52% reduction in risk of progression or death). Secondary outcomes cited included disease control rate 54% vs 27.5% and delayed deterioration in pain and physical function; benefit was consistent across prespecified subgroups including IDH-wild-type and IDH-mutant tumors.

Safety was described as generally manageable; common treatment-related AEs were fatigue, constipation, and nausea. One hepatotoxicity-related fatal event occurred early, prior to mitigation measures; treatment-related hepatic AEs were 11.8% vs 4.5% (mostly Grade 1–2).

The release notes prior FDA Fast Track (Jan 2021) and orphan drug designation (Nov 2021) for ozekibart in chondrosarcoma, and ongoing expansion cohorts combining ozekibart with irinotecan-based regimens in Ewing sarcoma and colorectal cancer.