CEL-SCI Corporation announced a significant milestone following a meeting with the U.S. Food and Drug Administration (FDA) regarding the approval pathway for its investigational cancer immunotherapy, Multikine (Leukocyte Interleukin, Injection). The FDA has given the green light for a confirmatory Registration Study targeting newly diagnosed advanced primary head and neck cancer patients with specific criteria, including no lymph node involvement and low PD-L1 tumor expression.
Geert Kersten, CEO of CEL-SCI, highlighted the importance of this development, stating that the survival benefit observed in the target patient population was so significant that the confirmatory study requires only 212 participants to validate the findings from the Phase 3 study. This study will be a randomized controlled trial comparing Multikine treatment plus standard of care against standard of care alone.
The decision to proceed with the confirmatory study was based on the compelling data from the Phase 3 study, which showed a 73% 5-year survival rate in Multikine-treated patients within the selected group, compared to a 45% survival rate in the control group. The FDA's agreement to the study design and patient selection criteria marks a critical step forward for CEL-SCI and offers hope for improved therapies for head and neck cancer patients.
Multikine's unique approach involves boosting the patient's immune system before surgery, a strategy that differs from most cancer immunotherapies, which are typically administered after conventional treatments have failed. The Phase 3 study enrolled 928 patients and demonstrated statistically significant survival benefits in the target population, effectively halving the risk of death at five years compared to the control group.
The FDA's acknowledgment of the unmet need for improved therapies in this patient population further underscores the potential impact of Multikine. CEL-SCI is optimistic about the confirmatory study's success, given the substantial survival benefits already observed in the Phase 3 study. If approved, Multikine could become a valuable addition to the standard of care for head and neck cancer patients, offering a new hope for those battling this challenging disease.
