Keryx Biopharmaceuticals' Phase 3 X-PECT Study of KRX-0401 Receives Green Light to Continue

Strategic Insights -

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) announced that the independent Data Safety Monitoring Board (DSMB) for the Company's pivotal Phase 3 X-PECT study of KRX-0401 (perifosine) in patients with refractory advanced colorectal cancer has completed a pre-specified interim analysis for safety and futility. The study has been cleared to proceed to completion, with over 465 patients from 65 U.S. sites enrolled.

Key Takeaways:

  • The Phase 3 X-PECT study has completed enrollment with 465 patients from 65 U.S. sites participating in the trial.
  • The study is a randomized, double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine in patients with refractory advanced colorectal cancer.
  • The primary endpoint of the study is overall survival, with secondary endpoints including overall response rate, progression-free survival, and safety.
  • Patients included in the study have failed available therapy including 5-fluorouracil, oxaliplatin, irinotecan, bevacizumab, and if KRAS wild-type, failed therapy with prior cetuximab and/or panitumumab.
  • The trial has received both Special Protocol Assessment (SPA) and Fast-Track Designation from the FDA.

Statistics:

  • 465 patients from 65 U.S. sites have been enrolled in the Phase 3 X-PECT study.
  • The study is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine.
  • Approximately 360 events of death will trigger the un-blinding of the study.

Sources:

  • Keryx Biopharmaceuticals, Inc. press release, no date given
  • Information Technology Newsweekly, "Keryx Biopharmaceuticals, Inc. Announces Interim Analysis of Pivotal Phase 3 X-PECT Study of KRX-0401", no date given
  • VerticalNews.com, "Keryx Biopharmaceuticals Announces Interim Analysis of Pivotal Phase 3 X-PECT Study of KRX-0401", no date given.