Safety and pathologic response of neoadjuvant pulsed electric field ablation and systemic therapy in early-stage...

The VIGOR study was designed to evaluate the pathologic response of soft tissue ablated with pulsed electric fields (PEFs) in non-small cell lung cancer (NSCLC) patients who are candidates for surgical resection following standard of care (SOC) neoadjuvant use of checkpoint inhibitor treatment plus platinum doublet chemotherapy (NCT05583188). The safety of adding PEF to this pathway of care was also evaluated. The primary endpoint was the pathologic response. Secondary endpoints included the rate of R0 (complete) resection, as well as the frequency, duration, and causes of any surgery cancellations or delays. Exploratory endpoints included the profiling of circulating immunocytes post ablation by flow cytometry. The study enrolled 5 patients and PEF energy was successfully delivered to targeted lesions in the lung. No issues were observed when accessing the tumor for delivery of PEF energy, and no device-related serious adverse events (SAEs) were observed. All patients initiated neoadjuvant therapy as planned. Four of five patients underwent surgical resection. Pathological assessment was performed on resected tumors and revealed that out of the four surgical patients three were pathologic complete response (pCR) and one had major pathologic response (MPR). In summary, this study supports the safety and feasibility of PEF ablation in NSCLC patients prior to neoadjuvant treatment with immune checkpoint blockade plus platinum doublet chemotherapy and planned surgical resection.