CEL-SCI CorporationCVM 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 IncMRK and Bristol Myers Squibb & CoBMS 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.
