Exelixis Reports Encouraging Interim Data From a Phase 2 Trial of XL647 as First-Line Therapy for Non-Small Cell L... (tation and 3 were EGFR wild-type. -- ...)

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Exelixis Reports Encouraging Interim Data From a Phase 2 Trial of XL647 as First-Line Therapy for Non-Small Cell Lung Cancer

Date:9/4/2007

tation, and 3 were EGFR wild-type.

-- All 6 patients with EGFR-activating mutations demonstrated clinical

benefit (5 PR, 1 SD).

-- XL647 is generally well tolerated in this patient population. The most

frequently reported adverse events assessed as being related to XL647

were diarrhea, rash, fatigue, and nausea, all of which were Grade 1 or

Grade 2 in severity.

"The data reported today demonstrate that XL647 has potential utility in patient populations with both mutated and wild-type EGFR," said Dr. Shirish Gadgeel of Karmanos Cancer Institute at Wayne State University. "Importantly, the data highlight that patients to date appear to have milder EGFR-related side-effects -- rash and diarrhea -- than previously described with other EGFR inhibitors while retaining potent anti-tumor activity with durable responses and stable disease. Although these are early results, they provide a compelling rationale for expediting the full development of XL647 in non-small cell lung cancer."

"These data suggest that XL647 has the potential for utility in patients with NSCLC who have an activating EGFR mutation and those with wild-type EGFRs. We believe these data support an aggressive clinical development strategy in first, second and third-line treatment as both a single agent and in combination with other therapies," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "Moreover, new data from an ongoing phase 1 trial of XL647 suggest that daily dosing results in higher drug concentrations than those observed to date in this phase 2 study with intermittent dosing. We expect to complete this evaluation of both daily and intermittent dosing schedules soon in order to select the optimal regimen and dose for the late-stage development of XL647."

The most frequently reported treatment-related adverse events (AEs) were Grade 1 and 2 diarrhea and fatigue, and Grade 1 nausea and rash. Six pat
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Exelixis Reports Encouraging Interim Data From a Phase 2 Trial of XL647 as First-Line Therapy for Non-Small Cell L...(tation and 3 were EGFR wild-type. -- ...)