Clinical and immunologic response of patients with advanced solid tumors vaccinated with an optimized cryptic hTERT peptide (Vx-001)

3030 Background: The clinical and immunologic efficacy of the optimized peptide TERT572Y (Vx-001) presented by HLA- A*0201 in patients with advanced malignancies was investigated. Methods: In the context of an expanded phase I-II study, 71 patients with advanced solid tumors (breast cancer n=10; NSCLC n=11; prostate cancer n=10; mCRC n=2; RCC n=6; pancreatic cancer/cholangiocarcinoma n=14; melanoma n=8; HCC n=3; others n=7) who had been previously treated with standard chemotherapy (disease status at enrollment: stable disease n=21 and progressive disease n=50) received two subcutaneous injections of 2 mg of the optimized TERT572Y peptide followed by four injections of 2 mg of the native TERT572 peptide given every three weeks. The peptide-specific immune responses were assessed by interferon-γ Elispot at baseline, before the 3rd (early response) and after the 6th (late response) vaccination. Clinical outcome was evaluated after the 6th vaccination (based on RECIST criteria) and every three months thereaf...