Inhibrx Biosciences, Inc. (INBX) has reported updated interim results from its Phase 1/2 study of Ozekibart (INBRX-109) combined with FOLFIRI in patients with locally advanced or metastatic, unresectable colorectal cancer. The trial enrolled heavily pretreated patients, many of whom had already progressed on irinotecan-based regimens.
Colorectal cancer remains one of the most challenging solid tumors to treat in late-line settings, where standard therapies often deliver limited benefit. The study's interim data suggest Ozekibart may offer meaningful disease control for patients with few remaining options.
The results showed an objective response rate of 20% among 45 evaluable patients, compared with historical response rates of 1-6% for current standard of care. Nearly half of these responses lasted more than six months, and outcomes were consistent across mutation subgroups. Median progression-free survival was 5.5 months, with 42% of patients progression-free at six-months. Overall disease control rate reached 87%, underscoring the potential of Ozekibart to stabilize tumor growth.
Safety findings indicated a manageable profile, with common side effects such as diarrhea, fatigue, and nausea generally mild to moderate. Importantly, no significant liver toxicity was observed despite most patients presenting with liver metastases at baseline.
Inhibrx plans to meet with the U.S. FDA later this year to discuss advancing Ozekibart into a first-line registrational trial in colorectal cancer. The company is also exploring accelerated pathways for fourth-line CRC and refractory Ewing sarcoma, alongside a Biologics License Application already submitted for conventional chondrosarcoma.
Ozekibart, a tetravalent death receptor 5 (DR5) agonist antibody, has previously demonstrated significant progression-free survival benefits in chondrosarcoma, marking it as the first investigational therapy to show such results in a randomized trial for that rare disease.
INBX has traded between $10.84 and $94.57 over the past year. The stock closed Tuesday's trading at $84.08, up 2.06%. In pre-market trading the stock is at $148.50, up 76.02%.
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