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Expert Review of Vaccines Volume 14, 2015 - Issue 12
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Prostate Cancer Immunotherapy with Sipuleucel-T: Current Standards and Future Directions

Xiao X WeiUCSF Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USACorrespondence[email protected]
,
Lawrence FongUCSF Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA
&
Eric J SmallUCSF Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA
Pages 1529-1541 | Published online: 21 Oct 2015

References

  • *of interest
  • **of considerable interest
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*The neoadjuvant study of sipuleucel-T in patients with localized prostate cancer demonstrating a local immune effect.

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*Analysis of antibodies in the serum of patients treated in the IMPACT trial identified antigen spread and IgG responses as a potential mechanism of action of sipuleucel-T.

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**The pivotal randomized, double-blind, multicenter Phase 3 IMPACT trial (D9902B) of sipuleucel-T versus placebo, leading to the approval of sipuleucel-T in men with asymptomatic or minimally symptomatic mCRPC.

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*D9901, the first randomized, double-blind, placebo-controlled Phase 3 trial of sipuleucel-T versus placebo showing an OS benefit of sipuleucel-T.

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*Integrated analysis of D9901 and D9902A trials, showing improved OS of sipuleucel-T versus placebo.

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**Post-hoc analysis of IMPACT trial exploring prognostic factors predictive of overall survival in patients treated with sipuleucel-T.

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*The first peer-reviewed publication of sipuleucel-T combined with a novel hormonal agent (abiraterone) for patients with asymptomatic or minimally symptomatic mCRPC.

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*Presents immunomonitoring data from the Phase 3 trials of sipuleucel-T versus placebo, demonstrating that antigen-specific immune responses to PA2024 and/or PAP predicted OS.

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