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Sunitinib Malate (Sutent) Safe and Effective for Gastrointestinal Stromal Tumors After Imatinib Fails: Presented at ESMO

By Jill Stein

ISTANBUL, TURKEY -- September 30, 2006 -- Sunitinib malate (Sutent) continues to demonstrate acceptable tolerability and "impressive" efficacy in patients with gastrointestinal stromal tumor (GIST) that have failed to respond to conventional therapy with imatinib mesylate (Gleevec), according to preliminary results of an ongoing "treatment-use" study presented here at the 31^st European Society for Medical Oncology (ESMO) Scientific and Educational Congress.

Sunitinib is a multi-targeted drug that inhibits a number of important kinase enzymes to exert antiangiogenic and antitumor effects.

"While imatinib is conventional first-line therapy for GIST, most patients for whom the agent is initially effective will eventually develop primary resistance to the drug," said Palma Dileo, MD, research fellow, Dana Farber Cancer Institute, Boston, Massachusetts, United States. "More than 40% of patients develop secondary imatinib resistance after a median of 25 months, and a small percentage are imatinib-intolerant."

The study was undertaken to grant sunitinib access to GIST patients who might derive benefit from this therapy but who are ineligible for sunitinib clinical trials because of pre-specified entry criteria, or for whom there are no GIST trials available in a particular country where regulatory approval has not yet been granted.

In the study, all patients receive sunitinib in repeated 6-week cycles at a starting dose of 50 mg once daily on a 4/2 schedule (4 weeks on treatment followed by 2 weeks off treatment). A provision is made for dose reduction in the event of toxicity.

The 698 patients included in the present analysis have received a median of 3 treatment cycles and have been treated for a median of 114 days. The median daily sunitinib dose received is 50 mg.

Overall, 277 (39.8%) patients had dose interruptions, of which 80.1% were due to adverse events.

Dose reductions have occurred in 129 patients (18.5%) overall, of which 76.0% were reduced to 37.5 mg and 21.7% to 25 mg.

Updated tumor-response data are available in 255 patients. Thus far, 4 (1.6%) achieved a partial response, 192 (75.3%) have demonstrated stable disease, and 59 (23.1%) have had progressive disease.

Sixty-seven patients (26.3%) demonstrated stable disease for at least 24 weeks, resulting in a clinical benefit rate of 27.8%.

Median time to disease progression was 23.7 weeks.

To date, most adverse events have been mild to moderate in severity -- National Cancer Institute Common Toxicity Criteria grade 1 or 2) -- and the safety profile observed is similar to that seen with sunitinib in prior GIST studies, and in other patient populations.

In her presentation on September 30^th, Dr. Dileo concluded that the results show that, consistent with prior phase 1-3 data, sunitinib is effective in the treatment of patients with GIST after imatinib failure.

The study was sponsored by Pfizer.


[Presentation title: Updated Results From a "Treatment-Use" Trial of Sunitinib in Advanced Gastrointestinal Stromal Tumor (GIST)". Abstract 507PD]

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