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Poniard Pharmaceuticals Announces Phase 2 Trial of Picoplatin in Metastatic Colorectal Cancer Meets Primary Endpoint and Study Objectives
Date:1/24/2010

aring alternative to oxaliplatin for the first-line treatment of metastatic CRC in 101 patients who had not received prior chemotherapy.  The trial's primary objective was to measure the relative incidence and severity of neuropathy in the FOLPI regimen compared to the FOLFOX regimen.  In addition, the study measured comparative safety and efficacy (assessed by disease control, progression-free survival (PFS) and overall survival (OS)) data; however, the study was not powered to assess the statistical significance of these secondary endpoints.  The final Phase 2 data indicated that:

  • FOLPI is associated with a statistically significant reduction in neurotoxicity compared to FOLFOX (HR <0.30; p <0.004).  Neuropathy, regardless of Grade, was 26 percent in FOLPI-treated patients and 62 percent in FOLFOX-treated patients. No Grade 3/4 neuropathy was observed with FOLPI.
  • FOLPI had similar efficacy to FOLFOX as measured by:
    • Disease Control of 75 percent and 76 percent for FOLPI and FOLFOX, respectively; (Relative risk 1.02 (95 percent Confidence Interval (CI) 0.79-1.32), p=0.9)
    • PFS of 6.8 months and 7.0 months for FOLPI and FOLFOX, respectively: HR 0.95 (95 percent CI 0.63-1.45), p=0.82
    • OS of 13.6 months and 15.6 months for FOLPI and FOLFOX, respectively: HR 1.17 (95 percent CI 0.72-1.91), p=0.53
  • Six-month and one-year survival rates were 80 percent and 52 percent for FOLPI and 83 percent and 55 percent for FOLFOX, respectively.
  • More patients who discontinued FOLFOX had associated neuropathy; neurotoxicity was not dose-limiting for FOLPI.  More patients who discontinued FOLPI had associated hematological events than with FOLFOX.
  • No hypersensitivity, cardiac or nephrotoxicity was observed with FOLPI or FOLFOX.
  • FOLPI had more frequent and severe, but manageable, thrombocytopenia an
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SOURCE Poniard Pharmaceuticals, Inc.
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