- The FDA approved Merck's Keytruda for head and neck cancer patients with PD-L1 positive tumors.
- CEL-SCI's Multikine shows promising results for PD-L1 negative patients, reducing death risk by 66%.
- CEL-SCI is set for a confirmatory Registration Study following favorable Phase 3 results.
The U.S. Food and Drug Administration (FDA) has granted approval to Merck's KEYTRUDA® (pembrolizumab) for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. This approval, based on interim results from the Phase 3 KEYNOTE-689 trial, marks a significant step for patients with PD-L1 positive tumors, as Keytruda demonstrated a 30% reduction in the risk of recurrence and progression compared to standard care.
CEL-SCI Corporation (CVM, Financial) celebrated this approval as it sets a positive precedent for its own investigational drug, Multikine. In its Phase 3 study, Multikine significantly reduced the risk of death by 66% in patients with low to zero PD-L1 expression, extending the 5-year overall survival rate to 73% from 45% in those receiving standard care. This indicates a potential breakthrough for patients unresponsive to PD-L1 targeting therapies like Keytruda.
In the wake of these developments, CEL-SCI has received the FDA's nod to initiate a confirmatory Registration Study with 212 newly diagnosed patients. The study aims to further substantiate Multikine's efficacy as a pre-surgery treatment, potentially accelerating regulatory approval due to its demonstrated survival benefits in patients with low PD-L1 expression.
CEL-SCI is based in Vienna, Virginia, and continues to focus on enhancing cancer treatment by leveraging the body's immune response prior to surgical interventions. As the company prepares for upcoming trials, the recent FDA approvals offer a promising future for Multikine in addressing unmet needs in head and neck cancer treatments.
