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NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD & NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS
Date:6/1/2009

port, the evidence for this claim will become increasingly robust."

Reddy BK et al. conducted a randomized Phase IIb, four-arm, open-label study designed to assess the safety and efficacy of nimotuzumab in combination with radiation therapy (RT) or chemoradiation therapy (CRT) in patients with inoperable (Stage III or IVa) squamous cell carcinoma of the head and neck (SCCHN). Stage III-IV SCCHN patients are reported to account for 50-60% of head and neck cancer patients. A total of 92 patients were enrolled of which 76 were considered evaluable. The addition of nimotuzumab to both the radiation and chemoradiation regimens improved the overall response rate, survival rate at 30 months, median progression-free survival and median overall survival. A combined group analysis of the nimotuzumab arms vs. the non-nimotuzumab arms demonstrated a significant difference in overall survival (p=0.0018) favoring nimotuzumab. The addition of nimotuzumab did not add to the severe toxicities of either regimen, with no Grade 3-4 skin toxicities observed. The results of the study are presented in the table below.

    Summary of Efficacy Parameters - Reddy BK et al study:
    -------------------------------------------------------------------------
    PARAMETER                             GROUP A            GROUP B
                                      ---------------------------------------
                                                  RT+               CRT+
                                        RT   nimotuzumab   CRT   nimotuzumab
    -------------------------------------------------------------------------
    Overall Response Rate
     (ORR = CR + PR) (%)      37       76         70       100
    -------------------------------------------------------------------------
    Survival Rates at 30 Months (%)   21.70    39.10      21.70     69.50*
    -------------------------------------------------------------------------
    Median Pro
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SOURCE YM BioSciences Inc.
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