ASCO 2017 - Metastatic castration-resistant prostate cancer: indoximod after sipuleucel-T boosts PFSl in phase 2 trial

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  • The maximum tolerated dose of indoximod (NewLink Genetics) 2400 mg/d twice daily for 24 wk, after standard treatment with sipuleucel-T (Provenge, Dendreon), was well tolerated and led to significant improvements in radiographic PFS.

Why this matters

  • Prostate cancer standard-of-care androgen deprivation therapy often leads to castration-resistant disease.
  • Sipuleucel-T cancer vaccine improves median OS vs placebo; indoximod inhibits the counter-regulatory IDO pathway exploited by tumors to defeat antitumor activity.
  • PFS improvement in this trial justifies a larger randomized study.

Study design

  • Randomized, double-blind, multiinstitutional phase 2 study of indoximod or placebo after the completion of standard of care (sipuleucel-T) in men with asymptomatic or minimally symptomatic metastatic prostate cancer that is hormone refractory.
  • Patients rando...