Brooklyn ImmunoTherapeutics Shares Tick lower After Data From Head and Neck Cancer Study

  • Brooklyn ImmunoTherapeutics Inc BTX has announced results from the INSPIRE Phase 2 trial of IRX-2 in patients with newly diagnosed stage II, III, or IVA squamous cell carcinoma of the oral cavity.
  • The study's primary endpoint was to estimate 2-year Event-Free Survival (EFS) with key secondary endpoints of Overall Survival (OS) and safety of IRX-2. 
  • 150 patients were enrolled in the study. At two years of follow-up in the intention-to-treat (n=105) population, the median EFS was 48.3 months and was not reached in the control arm (Hazard Ratio 1.10).
  • In key pre-specified subgroups, outcomes favored IRX-2. 
  • Patients in these subgroups were less likely to experience an EFS event in the IRX-2 arm compared to the control. 
  • Trends in EFS rates at two years of follow-up in patients with the later-stage disease were 57.2 vs. 49.4 in favor of IRX-2. 
  • In patients that did not receive chemotherapy (radiation only) as part of adjuvant treatment, the EFS was 76.4 vs. 60.6 in favor of IRX-2. 
  • There were no new safety signals observed with IRX-2. Adverse events related to study treatment were injection site reactions and fatigue.
  • Price Action: BTX shares are down 4.75% at $0.50 on the last check Tuesday.
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