Overview
- The 206-patient study met its primary endpoint, with median progression-free survival of 5.52 months versus 2.66 months on placebo (HR 0.479; 95% CI 0.33–0.68; P<0.0001).
- Inhibrx said it plans to file a U.S. FDA marketing application in the second quarter of 2026.
- Treatment benefit was observed across patient subgroups, including those with and without IDH mutations.
- One patient died from liver toxicity early in the trial, and the company instituted risk-reduction steps including stricter liver exclusions and closer early monitoring.
- Early combination data showed a 23% response rate with FOLFIRI in colorectal cancer and a 64% response rate with irinotecan/temozolomide in refractory Ewing sarcoma.