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  • CEL-SCI Corporation CVM said that its 10-year Phase 3 trial showed that Multikine immunotherapy significantly extended the lives of patients with locally advanced primary squamous cell carcinoma of the head and neck (SCCHN). 
  • The company says that current drug therapies for SCCHN from Merck & Co Inc MRK and Bristol Myers Squibb & Co BMS are approved as a last resort.
  • The Multikine treated study population showed the following advantages over control:
    • A median overall survival improvement of 46.5 months—nearly four years.
    • 62.7% of Multikine patients were alive after five years vs. 48.6% in control.
    • Nearly one out of every six patients had their tumors shrink by more than 30% in three weeks.
    • Five patients had their tumors completely disappear in just three weeks.
    • Tumor shrinkage/disappearance cut the death rate by a factor of three.
  • Merck’s drug Keytruda was approved for recurrent SCCHN based on a single-arm trial with a 16% tumor response rate. CVM says a randomized controlled trial showed the same response rate.
  • Keytruda did not show a survival improvement versus a 29% survival improvement for CVM’s immunotherapy.
  • BMS’s drug Opdivo was approved based on only a 2.4-month life extension. The company’s immunotherapy showed a median 46-month improvement in life extension. 
  • Furthermore, CVM highlights Multikine’s favorable toxicity profile than these approved products.
  • Price Action: CVM shares are up 3.19% at $2.91 on the last check Tuesday.

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