Data collected in a phase 2a trial of patients with squamous cell carcinoma of the head and neck (SCCHN) demonstrated that neoadjuvant IRX-2 stimulated lymphocyte infiltration (LI) into the tumors and that greater LI was associated with longer survival. The overall 5-year survival rate was 65% (17/26), and in patients with a large change in LI after treatment, there was a greater than 80% probability of survival at 5 years (LIavg vs survival, P<0.05).1 Of the 27 patients evaluable for safety, 85.2% experienced at least one treatment-emergent adverse event (TEAE). The most common (>10%) study drug-related TEAEs included nausea, injection site pain, headache, and dizziness. There were no drug-related deaths reported.2
Adapted from Wolf GT et al. Head Neck. 2011;33(12):1666-1674.