Volume 3 Supplement 2

30th Annual Meeting and Associated Programs of the Society for Immunotherapy of Cancer (SITC 2015)

Open Access

Superiority of dendritic cell vaccine vs tumor cell vaccine: survival by stratification subsets in MACVAC randomized Phase II trial of patient-specific vaccines utilizing antigens from autologous melanoma tumor cell lines

  • Robert O Dillman1,
  • Edward McClay2,
  • Thomas Amatruda3,
  • George Semeniuk4,
  • Clark Haskins5,
  • Robert Weber6,
  • David Burtzo7,
  • Carol DePriest8,
  • Denysha Carbonell1 and
  • Andrew Cornforth1
Journal for ImmunoTherapy of Cancer20153(Suppl 2):P202

DOI: 10.1186/2051-1426-3-S2-P202

Published: 4 November 2015

In a randomized Phase II trial conducted in patients with metastatic melanoma, superior overall survival (p=0.007) was observed for 18 patients treated with vaccines that consisted of autologous dendritic cells loaded with antigens from irradiated autologous melanoma stem cells, (DC-TC, aka eltrapuldencel-T, NBS20 and CBLS20) compared to 24 patients treated with vaccines consisting of autologous irradiated melanoma stem cells (TC) [ClinicalTrials.gov NCT00436930].[1] Both vaccines were admixed with GM-CSF as an adjuvant. Tumor cell lines that served as the source of patient-specific tumor-associated antigens were derived from metastases resected from patients with stage IV or recurrent stage III melanoma. The treatment schedule consisted of weekly subcutaneous injections for 3 weeks, and then monthly for 5 months. The current analysis was undertaken to determine the treatment effects of DC-TC vs TC in each of the subsets defined by the pre-randomization stratifications that were based on whether patients had measurable or non-measurable disease as defined by RECIST, and whether their most advanced stage of disease at the time of randomization had been stage IV or recurrent stage III disease. At the time of this analysis 5 DC-TC and 3 TC patients had been followed for 5 years; 5 patients (3 TC and 2 DC-TC) were alive but followed less than 5 years (minimum 3.5 years); 29 were deceased. No patients were lost to follow up. The survival results are summarized in Table 1. Although the numbers are small, DC-TC immunotherapy was associated with superior survival in each of the four different subsets defined by the stratification variables. Eltrapuldencel-T has moved forward into a pivotal Phase III trial sponsored by Caladrius BioSciences, Inc.

Table 1

Stratification

Treatment

# of patients

Median survival in months

3-year overall survival

Measurable

DC-TC

8

17.6

33%

Measurable

TC

9

6.5

11%

Non-Measurable

DC-TC

10

Not Reached

56%

Non-Measurable

TC

15

31.3

33%

Recurrent Stage III

DC-TC

3

Not Reached

67%

Recurrent Stage III

TC

6

30.3

17%

Stage IV

DC-TC

15

40.4

60%

Stage IV

TC

18

16.9

28%

Trial registration

ClinicalTrials.gov identifier NCT00436930.

Authors’ Affiliations

(1)
Caladrius BioSciences, Inc
(2)
California Cancer Associates for Research and Excellence (cCARE), Institute for Melanoma Research & Education
(3)
Minnesota Oncology
(4)
Orange Coast Oncology and Hematology
(5)
New Mexico Cancer Center
(6)
St. Mary's Medical Center and Sutter Health
(7)
Pacific Shores Medical Group
(8)
Cancer Biotherapy Research Group

References

  1. Dillman R, Cornforth A, DePriest C, et al: Tumor stem cell antigens as consolidative active specific immunotherapy: a randomized Phase II trial of dendritic cells versus tumor cells in patients with metastatic melanoma. J Immunother. 2012, 35: 641-649.PubMedView ArticleGoogle Scholar

Copyright

© Dillman et al. 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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