Market Report -- In Play (EXEL)
October 26, 2009 2:07 AM ET
Exelixis and Bristol-Myers report new Ph. 2 data for XL184 in patients with glioblastoma multiforme Co and Bristol-Myers Squibb (
BMY) report updated phase 2 clinical data which show that XL184 demonstrated activity in patients with glioblastoma multiforme, the most common and aggressive form of brain cancer. The data from study XL184-201 were presented during a poster session at the 2009 Joint Meeting of the Society for Neuro-Oncology and the AANS/CNS Section on Tumors. The study evaluates the safety, tolerability, and clinical activity of XL184 at continuous daily doses of 175 mg or 125 mg in patients with previously treated GBM, including some patients who had received prior antiangiogenic therapy. A total of 46 patients in first or second relapse were enrolled and dosed with 175 mg of XL184 administered daily, and enrollment at this dose level is complete. Due to frequent dose interruptions and reductions, the study was amended earlier this year to initiate a new cohort of patients receiving 125mg. As of October 12, 2009, 38 patients have been enrolled at the 125 mg dose level with 18 patients with at least one IRF read post baseline scan. Of the 38 patients enrolled at the 125 mg dose level as of October 12, 2009, 18 patients had at least one post-baseline scan available that had undergone IRF evaluation. Of these 18 patients, 7 have discontinued treatment -- 4 due to progressive disease/clinical deterioration per investigator and 3 due to adverse events. Of 14 antiangiogenic naive patients enrolled at this dose level, eight have had tumor shrinkage of more than 50% as determined by IRF, including two confirmed partial responses by IRF.
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