- CEL-SCI Corporation (NASDAQ:CVM) reported new data from its pivotal Phase 3 study of Multikine (Leukocyte Interleukin) in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN).
- The new data presented focuses exclusively on the patient population (n=352) from the IT-MATTERS study for which CEL-SCI is seeking regulatory marketing approval for locally advanced primary head and neck cancer patients scheduled to receive radiotherapy, but not chemotherapy, after surgery.
- Related: 10-Year Phase 3 Trial Shows CEL-SCI’s Multikine immunotherapy Extends Lives In Head & Neck Cancer Patients.
- Key study findings include:
- The overall survival advantage accelerated and increased, with Multikine+CIZ to the treatment regimen as compared to Standard of Care (SOC) alone increasing from 2.8% at three years to 8.3% at four years to 15.6% at 5 years, with a 49.7% survival for control vs. 65.3% for the Multikine treated group at 5 years.
- The hazard ratio was 0.70 representing a 43% survival extension.
- Progression-free survival was 8.4% higher at five years for patients treated with Multikine+ CIZ+SOC than those treated with SOC control alone.
- 16.5% of these patients were early tumor responders with Multikine compared to 0% of patients treated with SOC alone.
- Multikine patients who had an early tumor response had significantly improved survival. Their death rate was only 15.6% vs. 48.7% death rate for the control patients.
- Even the patients who did not have an early tumor response had better survival than the control group patients, with a 43.8% death rate vs. a 48.7% death rate for control.
- Price Action: CVM shares are up 1.73% at $2.94 on the last check Wednesday.
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