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LUD 00-009: Phase 1 study of intensive course immunization with NY-ESO-1 peptides in HLA-A2 positive patients with NY-ESO-1-expressing cancer

Armin Bender¹, Julia Karbach¹, Antje Neumann¹, Dirk Jäger², Salah E. Al-Batran¹, Akin Atmaca¹, Eckhart Weidmann¹, Melina Biskamp¹, Sacha Gnjatic³, Linda Pan³, Eric Hoffman³, Lloyd J. Old³, Alexander Knuth⁴ and Elke Jäger¹

¹Klinik für Onkologie und Hämatologie, Krankenhaus Nordwest, Frankfurt, Germany

²Nationales Centrum für Tumortherapie, Heidelberg, Germany

³Ludwig Institute for Cancer Research, New York, USA

⁴Klinik für Onkologie, Universitätsspital, Zürich, Switzerland

Abstract

NY-ESO-1 is a cancer-testis antigen and an attractive target for immunotherapy in patients with different malignancies. Here we report the results of a phase I clinical study of intensive course NY-ESO-1 peptide vaccination, evaluating the safety, immunogenicity and clinical response in HLA-A2 positive patients with NY-ESO-1 expressing cancers. Of 20 patients enrolled in the trial, 14 completed at least 2 cycles of immunization and were evaluable for clinical and immunological response. Five of these evaluable patients were treated in cohort 1 (baseline seropositive) and 9 patients were treated in cohort 2 (baseline seronegative). During vaccination, NY-ESO-1-specific CD8+ T-cells were induced in 3 of 9 baseline seronegative patients. In patients with pre-existing antigen-specific CD8+ T-cells, their number increased or remained stable. In contrast to previous immunization protocols with less intensive immunization schedules, we observed a rapid induction of high magnitude NY-ESO-1 peptide-specific T-cell responses detectable already on day 15-22 of immunization. A specific immune response of high magnitude and early onset may be more effective in eliminating minimal residual disease in adjuvant treatment situations and in preventing tumor progression due to immune escape mechanisms.