Inhibrx's Ozekibart Shows Promising Results in Late-Line Colorectal Cancer

Event summary

  • Inhibrx reported interim Phase 1/2 data for ozekibart (INBRX-109) in combination with FOLFIRI, showing a 20% objective response rate (ORR) in heavily pretreated colorectal cancer patients.
  • Median progression-free survival (PFS) was 5.5 months, with 42% of patients progression-free at 6 months.
  • The disease control rate (DCR) was 87%, and the safety profile remained manageable with no significant liver toxicity observed.
  • Inhibrx plans to meet with the FDA in H2 2026 to discuss a first-line registrational trial for CRC and potential accelerated pathways for fourth-line CRC and refractory Ewing sarcoma.

The big picture

Inhibrx's positive interim data for ozekibart in late-line colorectal cancer positions the drug as a potential new option in a heavily pretreated patient population. The results suggest meaningful clinical activity, which could drive further regulatory discussions and expand the drug's potential into earlier lines of therapy. This development comes as Inhibrx continues to build its pipeline of novel biologic therapeutic candidates, leveraging its protein engineering platforms.

What we're watching

Regulatory Pathways
Whether the FDA will grant accelerated approval for ozekibart in fourth-line colorectal cancer and refractory Ewing sarcoma.
Clinical Development
The pace at which Inhibrx advances into first-line registrational trials for CRC, potentially expanding the drug's market opportunity.
Indication Expansion
How broader expansion of ozekibart into other indications may impact its long-term strategic value and pipeline diversification.