FDA Approval of Keytruda® in Head and Neck Cancer Highlights Potential for Gedeptin® Combination Therapy

The recent U.S. Food and Drug Administration approval of Keytruda® (pembrolizumab) for resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) has been met with optimism by GeoVax Labs, Inc., a clinical-stage biotechnology company. This approval not only marks a significant step forward in the treatment of head and neck cancer but also underscores the therapeutic potential of combining Keytruda with GeoVax's Gedeptin®. The combination aims to leverage the immune-priming effect of Gedeptin's targeted cytotoxicity with the systemic immune activation provided by checkpoint inhibitors like pembrolizumab.

GeoVax is preparing to initiate a Phase 2 clinical trial in 2026 to evaluate the efficacy of Gedeptin in combination with a checkpoint inhibitor for patients with locally advanced HNSCC scheduled for curative-intent surgery. The trial will focus on improving tumor clearance and reducing relapse rates, with an emphasis on biomarker-defined immunologic changes. This approach aligns with the broader need to optimize patient selection and treatment duration in the era of immunotherapy, as highlighted in a recent editorial by Rosenberg and Vokes in the New England Journal of Medicine.

David Dodd, Chairman and CEO of GeoVax, remarked on the significance of the FDA's approval, stating it heralds a new era in curative-intent cancer therapy. The combination of Gedeptin therapy with pembrolizumab is anticipated to enhance local tumor eradication and systemic anti-tumor immunity, potentially reducing both local and distant recurrence. Dr. Kelly McKee, GeoVax's Chief Medical Officer, added that Gedeptin's tumor-targeted cytotoxicity could significantly improve immunotherapy efficacy, especially in the perioperative window where anti-tumor immunity can be primed.

Gedeptin®, a gene-directed enzyme prodrug therapy, has been granted Orphan Drug Designation by the FDA for the treatment of oral and pharyngeal cancers. Its mechanism of action involves the selective generation of a cytotoxic agent within the tumor microenvironment, offering dual cytotoxicity and immune modulation with minimal systemic exposure. This innovative approach represents a promising strategy to complement checkpoint inhibitors and overcome tumor immune resistance across various solid tumor types.