Pfizer’s Sutent shows efficacy in Gleevec-resistant tumors

Results from a double-blind phase III study of more than 300 gastrointestinal stromal tumors (GIST) patients resistant to or intolerant of the standard treatment, Gleevec (imatinib mesylate), showed Sutent (sunitinib malate) significantly prolonged the time to tumor progression and reduced the risk of death by approximately 50% compared to placebo.

In addition, long-term follow-up data from the phase I/II GIST study that served as the basis for the larger phase III trial demonstrated that Sutent extended overall survival to nearly 20 months in patients whose cancer had progressed despite treatment with other standard therapies.

Encouraging phase II results also were observed in other tumor types, including metastatic renal cell carcinoma (mRCC), metastatic breast cancer and neuroendocrine tumors, according to new data presented at the annual meeting of the American Society of Clinical Oncology (ASCO).

“These results substantiate the concept that multi-targeted molecular therapy can overcome resistance to other targeted drugs in cancer,” said Dr George Demetri of Harvard University’s Dana-Farber Cancer Institute in Boston, the lead investigator on the Sutent trial for GIST.

“We think that Sutent may have a broad spectrum of activity for many different forms of cancer beyond what we have seen in patients with GIST. We believe that Sutent is an important step forward in cancer therapy.”