Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2014 Oct;86(1):59-66.
doi: 10.1016/j.lungcan.2014.07.018. Epub 2014 Aug 5.

A phase II trial evaluating the clinical and immunologic response of HLA-A2(+) non-small cell lung cancer patients vaccinated with an hTERT cryptic peptide

Athanasios Kotsakis  1 , Elisavet Papadimitraki  2 , Eleni Kyriaki Vetsika  3 , Despoina Aggouraki  3 , Eleftheria Kleio Dermitzaki  4 , Dora Hatzidaki  4 , Nikolaos Kentepozidis  5 , Dimitris Mavroudis  2 , Vassilis Georgoulias  2
Affiliations
Clinical Trial

A phase II trial evaluating the clinical and immunologic response of HLA-A2(+) non-small cell lung cancer patients vaccinated with an hTERT cryptic peptide

Athanasios Kotsakis et al. Lung Cancer. 2014 Oct.

Abstract

Objectives: The immunological and clinical responses of patients with NSCLC treated, in the context of an expanded action program, with the cryptic hTERT-targeting Vx-001 vaccine are presented.

Materials and methods: Forty-six HLA-A*0201-positive patients with advanced NSCLC and residual (n=27) or progressive (n=19) disease following front-line treatment received two subcutaneous injections of the optimized TERT572Y peptide followed by four injections of the native TERT572 peptide, every 3 weeks. Peptide-specific immune responses were monitored by enzyme-linked immunosorbent spot assay at baseline, and after the 2nd and the 6th vaccinations. Thirty-eight HLA-A*0201-positive matched patients were used as historical controls.

Results: Twenty-three patients (50%) completed the vaccination protocol and 87% received at least two administrations. Twelve patients (26%) without disease progression after the 6th vaccination received boost vaccinations. Three (7%) patients achieved a partial response and 13 (28%) disease stabilization. The disease control rate was significantly higher in patients with non-squamous histology compared to those with squamous-cell histology [n=14 (45%) versus n=2 (13%); p=0.03]. The median progression-free survival (PFS) and overall survival (OS) was 3.8 (range, 0.7-99.4) and 19.8 months (range, 0.7-99.4), respectively. Patients who developed immune response had a numerically higher PFS compared to those who failed to mount any (6.7 versus 2.7 months; p=0.090). However, the median OS for the immune-responders was significantly prolonged compared to non-responders (40.0 versus 9.2 months, respectively; p=0.02). Toxicity was <grade 2.

Conclusion: Vx-001 vaccine is well tolerated and induced a TERT-specific immunological response, which was significantly correlated with improved clinical outcome.

Keywords: Clinical efficacy; HLA-A2+; Immunologic response; NSCLC; Phase II; h-TERT.

PubMed Disclaimer

Publication types

MeSH terms