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Clinical Review Abstract

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Safety profile of recombinant poxviral TRICOM vaccines.

Prostate Cancer

Genitourinary (Prostate) Cancer

2013 ASCO Annual Meeting

Abstract No:

J Clin Oncol 31, 2013 (suppl; abstr e16036)

Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2013 Annual Meeting but not presented at the Meeting, can be found online only.

Author(s): Joseph W. Kim, Jennifer L. Marte, Nishith K. Singh, Christopher Ryan Heery, Ravi Amrit Madan, Mary Pazdur, Sheri McMahon, Myrna Rauckhorst, Jeffrey Schlom, Philip W. Kantoff, James L. Gulley; Medical Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD; National Cancer Institute, Bethesda, MD; Laboratory of Tumor Immunology and Biology, Medical Oncology Branch, National Cancer Institute, Bethesda, MD; Medical Oncology Branch, National Cancer Institute, Bethesda, MD; Laboratory of Tumor Immunology and Biology, Center for Cancer Research, Bethesda, MD; Dana-Farber Cancer Institute, Boston, MA

Abstract Disclosures


Background: Recombinant (rec) poxviruses have been developed as therapeutic cancer vaccines. A multi-institutional, randomized phase II trial of poxviral vaccine, PROSTVAC-V/F, suggested an improvement in median overall survival in men with metastatic castration resistant prostate cancer. A phase III trial in this same population is accruing. Accumulating data suggest a favorable safety profile of the poxviral vaccines (vacs). Methods: We reviewed all vaccine injections (inj) from 297 patients (pts) in 9 clinical trials involving poxviral vaccines. Vacs consisted of rec vaccinia and rec fowlpox encoded with 3 human costimulatory molecules (TRICOM), and a) prostate specific antigen, or b) carcinoembryonic antigen +/-mucin-1. Vacs were administered at doses between 1.2x108 to 2x109 pfu, subcutaneously, in all pts. 21 pts were also vaccinated intra-tumorally. 84 pts received concurrent treatments, such as radiation, celecoxib, ipilimumab, samarium-153, or flutamide in 4 of these trials. All 9 trials involved granulocyte-macrophage colony-stimulating factor (GM-CSF), or rec fowlpox encoding GM-CSF as an immune adjuvant. We report the grade >=2 adverse events (AEs) at least possibly attributed to vaccine. Results: A total of 1,793 poxviral inj were given. 33% (593) of all inj were associated with grade >=2 vaccination emergent AEs. Of those, 25.3 % (454) were local inj site reactions; none serious. There was no contact transmission or inadvertent inoculation. One patient experienced grade 4 myocardial infarction and thrombotic thrombocytopenic purpura (TTP) reported as possibly related to vaccine. Below is the summary of AEs. Conclusions: Recombinant poxviral TRICOM vaccines appear safe and well tolerated at a broad range of doses, routes of administration and in combination with other treatments. Clinical trial information: NCT00081848, NCT00088413, NCT00060528, NCT00060528, NCT00078585, NCT00096551, NCT00113984.

AEs Grade (G) 2 G 3 G 4 % of injections
associated with an AE
Injection site reaction 454 0 0 25.3
Injection site cellulitis 0 2 0 0.1
Fever 22 2 0 1.3
General (fatigue, myalgia, rash, etc.) 53 7 0 3.3
Respiratory (dyspnea, etc.) 4 2 0 0.3
Gastrointestinal (nausea, etc.)
13 3 0 0.9
Neurologic (headache, etc.) 9 2 0 0.6
Hypotension 3 0 0 0.2
Myocardial infarction 0 0 1 0.1
Atrial fibrillation 1 0 0 0.1
Cytopenia 6 1 0 0.4
TTP 0 0 1 0.1
Lab abnormalities 7 0 0 0.4
Total 572 19 2 33.1


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