Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 2580
© 2005 American Society of Clinical Oncology

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Abstract

A phase I/II study of telomerase peptide vaccination of patients with non-small cell lung cancer

The Norwegian Radium Hosp, Univ of Oslo, Oslo, Norway; GemVax AS, Oslo, Norway; GemVax AS, Oslo, Norway

2580

Background: A phase I/II study was conducted to investigate the safety, tolerability and clinical response to vaccination with a combination of telomerase peptides GV1001 (hTERT: 611–626) and HR2822 (hTERT: 540–548).Methods: Twenty-six patients with non-small cell lung cancerreceived intradermal administrations of either 112 µg or 560 µg GV1001 in combination with 68.4 µg HR2822 and granulocyte macrophage-colony stimulating factor. The treatment period was ten weeks. Booster vaccinations with 560 µg GV1001 were offered as follow-up. Monitoring of blood samples, clinical examination and radiological staging were performed regularly. Immune responses were measured as delayed-type hypersensitivity skin reaction and in vitro T-cell proliferation. Bone marrow function was monitored in long time survivors. Our regional medical research ethics committee has approved the study and signed informed consent was obtained in all subjects. Results: The treatment was well tolerated with minor side effects. Immune responses against GV1001 were detected in 11 of 24 evaluable patients during the primary regimen and in an additional two patients following booster injections. Two patients responded to HR2822. Cloned GV1001-specific CD4+ T cells displayed a Th1 cytokine profile and recognized autologous antigen presenting cells pulsed with recombinant telomerase protein. No bone marrow toxicities were observed in long time survivors with immune responses. A complete tumor response was observed in one patient who developed GV1001-specific cytotoxic T cells that could be cloned from peripheral blood. Conclusions: Telomerase vaccination of patients with advanced treatment resistant NSCL cancer is feasible and results in potentially beneficial immune responses in about 50% of vaccinated patients.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration GemVax GemVax

Abstract presentation from the 2005 ASCO Annual Meeting