A PHASE II trial examining neoadjuvant therapy for difficult-to-resect cutaneous basal cell carcinoma (BCC) demonstrates promising outcomes. The study evaluated the efficacy of a genetically engineered oncolytic virus in 18 patients, achieving a 50% resectability rate after just six treatment cycles. This approach eliminates the need for plastic reconstructive surgery in half of the cases, making it a potential game-changer for complex skin cancer management.
BCC, the most common cancer worldwide, often requires extensive surgical intervention, particularly for advanced cases. Standard treatments, while effective, can result in recurrence and cosmetic or functional complications. Neoadjuvant therapies aim to improve surgical outcomes, but current options like Hedgehog inhibitors are limited by significant side effects, including fatigue and hair loss, leading to low patient compliance.
This trial utilized an oncolytic virus engineered to selectively target tumor cells while stimulating the immune system. Of the participants, 55.6% achieved an objective response, with 33.3% showing a complete pathological response. Impressively, six-month relapse-free survival and overall survival rates were 100%.
The therapy was well-tolerated, with only mild adverse events reported, and demonstrated significant immune-modulating effects within the tumor microenvironment. Researchers noted increases in cytotoxic T cells, B cells, and myeloid cells, alongside a decrease in immunosuppressive regulatory T cells.
The study was discontinued early due to success in achieving its primary endpoint, underscoring the potential of this immunotherapy for challenging BCC cases. The findings pave the way for further exploration of neoadjuvant oncolytic virus therapies in accessible cancers with high mutational burdens.
Reference: Ressler JM et al. Efficacy and tolerability of neoadjuvant therapy with Talimogene laherparepvec in cutaneous basal cell carcinoma: a phase II trial (NeoBCC trial). Nat Cancer. 2025;6:51-66.
Anaya Malik | AMJ
