- Critical milestone achieved—the FDA accepted CEL-SCI's selection criteria defining the Multikine target population before surgery
- Selected patient population had 73% survival with Multikine vs. 45% without Multikine based on analysis of completed 928-patient Phase 3 randomized controlled trial
- 212-patient confirmatory study is de-risked, backed by robust efficacy and safety data from completed Phase 3 trial, the largest in advanced primary head and neck cancer
- View CEL-SCI's comprehensive report regarding the FDA's go-ahead and the Company's value proposition for investors here:
CEL-SCI Corporation (NYSE:CVM) today announced a significantly positive outcome from its recent meeting with the U.S. Food and Drug Administration (FDA) regarding the path to approval for its first-line investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection). Based on strong safety and efficacy data from CEL-SCI's completed Phase 3 head and neck cancer study, the FDA indicated CEL-SCI may move forward with a confirmatory Registration Study of Multikine in newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy).
"Through this discussion and agreement with the FDA, we have achieved a tremendous milestone for people who are newly diagnosed with head and neck cancer. The survival benefit was so strong and clear in the target patient population that our confirmatory study needs to enroll only 212 people to confirm what was already achieved in the Phase 3 study. This gives us a clear path forward," stated CEL-SCI CEO, Geert Kersten. "We are eager to begin the study as soon as possible."
CEL-SCI published a report on the FDA's agreement and Multikine's path forward. Please click on this link to read the full report. Highlights include: