Inhibrx Shows 20% ORR and 5.5-Month PFS in Late-Line Colorectal Cancer Study
Inhibrx reported Phase 1/2 interim results for ozekibart plus FOLFIRI in 45 heavily pre-treated colorectal cancer patients, achieving ORR 20%, median PFS 5.5 months and DCR 87%. 42% of patients remained progression-free at 6 months with responses durable over six months, supporting planned FDA meeting to discuss first-line registrational trial.
1. Interim Efficacy Results
As of April 10, 2026, 45 evaluable patients with locally advanced or metastatic colorectal cancer receiving ozekibart plus FOLFIRI achieved an objective response rate of 20% per RECIST v1.1 criteria, compared with historical ORRs of 1–6%. Median progression-free survival reached 5.5 months, with a disease control rate of 87% and 42% of patients progression-free at six months.
2. Safety Profile
Ozekibart combined with FOLFIRI maintained a manageable safety profile, with most treatment-related adverse events—diarrhea, fatigue and nausea—graded 1 or 2. Despite 68% of patients presenting with liver metastases at baseline, no significant liver toxicity was observed, aligning with expected FOLFIRI side effects.
3. Development Plans and Next Steps
Inhibrx plans to meet with the FDA in the second half of 2026 to discuss initiation of a first-line registrational trial in colorectal cancer and potential accelerated pathways for fourth-line CRC and refractory Ewing sarcoma. In April 2026, the company also submitted a Biologics License Application for ozekibart in conventional chondrosarcoma.