Exelixis Reports Phase 1 and Phase 2 Data For XL6...( Data Show Activity in First- a...),Health

Data Show Activity in First- and Late-Line Treatment of NSCLC

CHICAGO, June 2 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL) reported data from three clinical trials of XL647, a novel small molecule inhibitor of EGFR, HER2, and VEGFR2, at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO). Updated data from an ongoing phase 2 trial in previously untreated, clinically selected non-small cell lung cancer (NSCLC) patients show encouraging anti-tumor activity of XL647 administered on an intermittent dosing schedule or a continuous daily dosing schedule. Additionally, data from a phase 2 trial in patients who progressed after prior benefit from erlotinib or gefitinib, or who have a documented EGFR-T790M mutation, also show encouraging signs of activity of XL647 in this heavily pretreated population. Furthermore, XL647 was generally well tolerated and showed favorable exposure and tolerability profiles in a phase 1 trial evaluating daily dosing in patients with advanced solid tumors.

Phase 2 Trial of XL647 in Clinically Selected NSCLC Patients Enriched for the Presence of EGFR Mutations

In this trial, patients with NSCLC were clinically selected on the basis of adenocarcinoma histology, and either having a documented EGFR activating mutation in their tumor, or meeting one of the following criteria: Asian, female, or minimal smoking history. Approximately 30% of the patients analyzed had EGFR activating mutations. A total of 41 patients were treated with 350 mg of XL647 on an intermittent (5 days on/9 days off) dosing schedule, while 8 patients were treated with 300 mg of XL647 on a daily dosing schedule.

Consistent with data from this phase 2 trial reported in October 2007 at the
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