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| |  IPI-504 Fails to Improve Outcomes for Patients With GIST Refractory to TKIs: Presented at ASCO-GI By Ed Susman ORLANDO, Fla -- January 24, 2010 -- Patients diagnosed with gastrointestinal stromal tumours (GIST) who were refractory to treatment with tyrosine kinase inhibitors (TKIs) did not appear to be helped by treatment with the experimental drug IPI-504 (retaspimycin hydrochloride), according to a study presented here at the 2010 Gastrointestinal Cancers Symposium (ASCO-GI). The trial was truncated because researchers observed a higher mortality rate among the patients receiving IPI-504 when compared with those receiving placebo. “We believe that the dose of IPI-504 was too high for this patient population with this condition,” said Eduardo Rodenas, MD, Infinity Pharmaceuticals, Cambridge, Massachusetts, during a presentation on January 22. “However, we believe there may be a role for this drug in the treatment of diseases such as breast cancer if we treat with a lower dose.” Researchers planned a phase 3 study that would evaluate IPI-504 in 195 patients whose gastrointestinal stromal cancers were observed to progress, despite treatment with imatinib or sunitinib. After 47 patients were enrolled, 8 deaths were recorded -- 2 in the pretreatment period which indicated the advanced stage of the disease among the persons in the trial. Five of the patients on IPI-504 died, including 1 in the open-label treatment following disease progression; 1 of the placebo patients died following disease progression. At the time the trial was halted, 24 patients had been assigned to best supportive care plus IPI-504 400 mg/m2 twice a week on a 2-week-on, 1-week-off schedule. Another 15 patients were assigned to placebo plus best supportive care. All patients were in performance status 0 to 1. Patients assigned to IPI-504 had been treated on imatinib for a median of 17 months; those assigned to placebo had been on imatinib for a median of 31 months. When imatinib was not effective, patients took sunitinib, and each group had about >=10 months on that treatment before it, too, stopped being effective. Funding for this study was provided by Infinity. The 2010 Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association Institute, the American Society of Clinical Oncology, the American Society for Therapeutic Radiation Oncology, and the Society of Surgical Oncology. [Presentation title: Final Results From a Phase III Study of IPI-504 (Retaspimycin Hydrochloride) Versus Placebo in Patients (pts) With Gastrointestinal Stromal Tumors (GIST) Following Failure of Kinase Inhibitor Therapies. Abstract 64]
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