Neoadjuvant enoblituzumab in localized prostate cancer: a single-arm, phase 2 trial

Eugene Shenderov, Angelo M. De Marzo, Tamara L. Lotan, Hao Wang, Sin Chan, Su Jin Lim, Hongkai Ji, Mohamad E. Allaf, Carolyn Chapman, Paul A. Moore, Francine Chen, Kristina Sorg, Andrew M. White, Sarah E. Church, Briana Hudson, Paul A. Fields, Shaohui Hu, Samuel R. Denmeade, Kenneth J. Pienta, Christian P. PavlovichAshley E. Ross, Charles G. Drake, Drew M. Pardoll, Emmanuel S. Antonarakis

Research output: Contribution to journalArticlepeer-review


B7 homolog 3 (B7-H3; CD276), a tumor-associated antigen and possible immune checkpoint, is highly expressed in prostate cancer (PCa) and is associated with early recurrence and metastasis. Enoblituzumab is a humanized, Fc-engineered, B7-H3-targeting antibody that mediates antibody-dependent cellular cytotoxicity. In this phase 2, biomarker-rich neoadjuvant trial, 32 biological males with operable intermediate to high-risk localized PCa were enrolled to evaluate the safety, anti-tumor activity and immunogenicity of enoblituzumab when given before prostatectomy. The coprimary outcomes were safety and undetectable prostate-specific antigen (PSA) level (PSA0) 1 year postprostatectomy, and the aim was to obtain an estimate of PSA0 with reasonable precision. The primary safety endpoint was met with no notable unexpected surgical or medical complications, or surgical delay. Overall, 12% of patients experienced grade 3 adverse events and no grade 4 events occurred. The coprimary endpoint of the PSA0 rate 1 year postprostatectomy was 66% (95% confidence interval 47–81%). The use of B7-H3–targeted immunotherapy in PCa is feasible and generally safe and preliminary data suggest potential clinical activity. The present study validates B7-H3 as a rational target for therapy development in PCa with larger studies planned. The identifier is NCT02923180.

Original languageEnglish (US)
Pages (from-to)888-897
Number of pages10
JournalNature medicine
Issue number4
StatePublished - Apr 2023

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)


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