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Cancer Therapy: Clinical

A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer

Eric J. Small, Raymond S. Lance, Thomas A. Gardner, Lawrence I. Karsh, Lawrence Fong, Candice McCoy, Todd DeVries, Nadeem A. Sheikh, Debraj GuhaThakurta, Nancy Chang, Charles H. Redfern and Neal D. Shore
Eric J. Small
1UCSF Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, California.
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  • For correspondence: smalle@medicine.ucsf.edu
Raymond S. Lance
2Eastern Virginia Medical School/Urology of Virginia PLLC, Norfolk, Virginia.
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Thomas A. Gardner
3Department of Urology at Indiana University School of Medicine, Indianapolis, Indiana.
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Lawrence I. Karsh
4The Urology Center of Colorado, Denver, Colorado.
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Lawrence Fong
1UCSF Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, California.
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Candice McCoy
5Dendreon Pharmaceuticals, Inc., Seattle, Washington.
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Todd DeVries
5Dendreon Pharmaceuticals, Inc., Seattle, Washington.
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Nadeem A. Sheikh
5Dendreon Pharmaceuticals, Inc., Seattle, Washington.
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Debraj GuhaThakurta
5Dendreon Pharmaceuticals, Inc., Seattle, Washington.
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Nancy Chang
5Dendreon Pharmaceuticals, Inc., Seattle, Washington.
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Charles H. Redfern
6Sharp Clinical Oncology Research, San Diego, California.
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Neal D. Shore
7Carolina Urologic Research Center, Myrtle Beach, South Carolina.
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DOI: 10.1158/1078-0432.CCR-15-0079 Published September 2015
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Abstract

Purpose: This phase II open-label study evaluated the effect of concurrent or sequential administration of abiraterone acetate plus prednisone (AA + P) on sipuleucel-T manufacture and immune responses in metastatic castration-resistant prostate cancer (mCRPC) patients.

Experimental Design: mCRPC patients received sipuleucel-T followed by AA + P 1 day (concurrent) or 10 weeks (sequential) after the first sipuleucel-T infusion. AA + P treatment continued for 26 weeks. The primary endpoint was cumulative antigen presenting cell (APC) activation, and secondary endpoints included cumulative APC number and total nucleated cell counts. Additional endpoints included in vivo peripheral immune responses to sipuleucel-T (T-cell responses, T-cell proliferation, humoral responses, and antigen spread) as well as safety.

Results: Sixty-nine mCRPC patients were enrolled, with 35 and 34 patients randomized to the concurrent and sequential arms, respectively. Ex vivo APC activation was significantly greater at the second and third infusions compared with baseline in both arms (P < 0.05), indicative of an immunologic prime-boost effect. In both arms, sipuleucel-T product parameter profiles and peripheral immune responses were consistent with previously conducted sipuleucel-T phase III trials. Antigen spread was similarly observed in both arms and consistent with the other immunologic endpoints.

Conclusions: These data suggest that sipuleucel-T can be successfully manufactured during concurrent administration of AA + P without blunting immunologic effects or altering immune parameters that correlate with sipuleucel-T's clinical benefit. Combination of these agents was well tolerated, with no new safety signals emerging. Clin Cancer Res; 21(17); 3862–9. ©2015 AACR.

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Received January 11, 2015.
  • Revision received April 8, 2015.
  • Accepted April 9, 2015.
  • ©2015 American Association for Cancer Research.
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Clinical Cancer Research: 21 (17)
September 2015
Volume 21, Issue 17
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A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer
Eric J. Small, Raymond S. Lance, Thomas A. Gardner, Lawrence I. Karsh, Lawrence Fong, Candice McCoy, Todd DeVries, Nadeem A. Sheikh, Debraj GuhaThakurta, Nancy Chang, Charles H. Redfern and Neal D. Shore
Clin Cancer Res September 1 2015 (21) (17) 3862-3869; DOI: 10.1158/1078-0432.CCR-15-0079

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A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer
Eric J. Small, Raymond S. Lance, Thomas A. Gardner, Lawrence I. Karsh, Lawrence Fong, Candice McCoy, Todd DeVries, Nadeem A. Sheikh, Debraj GuhaThakurta, Nancy Chang, Charles H. Redfern and Neal D. Shore
Clin Cancer Res September 1 2015 (21) (17) 3862-3869; DOI: 10.1158/1078-0432.CCR-15-0079
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