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Exelixis Reports XL647 Clinical Data at AACR-NCI-EORTC Conference
Date:10/24/2007

this study had enrolled 26 patients with a variety of advanced solid tumors. 11 of 21 patients assessable for tumor response receiving doses of XL647 ranging from 75 to 300 mg achieved stable disease for at least three months. The XL647 exposure with daily dosing at the maximum tolerated dose (MTD) (300 mg) in this study was approximately twofold higher over a 28-day cycle compared to the exposure observed previously at the MTD (350 mg) for the intermittent dosing regimen. XL647 was generally well tolerated and related Grade 3 adverse events were infrequent. No Grade 3 or greater skin rash was reported in this study. Pharmacodynamic analyses were conducted in plasma samples and eyebrow hair follicles. Biomarker changes consistent with EGFR inhibition were observed in eyebrow hair follicles following XL647 treatment.

"The phase 2 data continue to show encouraging anti-tumor activity for XL647 given on an intermittent schedule in previously untreated clinically selected NSCLC patients. Additionally, phase 1 data suggest that XL647 dosed daily at 300 mg is well tolerated and provides approximately twofold higher drug exposure over a 28-day cycle compared to intermittent dosing," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "We are pleased to continue to see evidence of good tolerability and no Grade 3 rash with XL647, and believe that a daily dosing strategy may have the potential to further enhance the anti-tumor activity in NSCLC."

The most common treatment-related adverse events (AEs) were Grade 1 and 2 diarrhea and dysgeusia, fatigue, rash, and clinically asymptomatic QTc prolongation. In phase 1, a total of ten serious AEs were reported in six patients; of these events, two were considered possibly or probably related to XL647. These two drug-related events of Grade 3 pneumonitis and Grade 4 myocardial infarction occurred in the same patient. The cohort was expanded, and no further dose-limiting toxicities (DLTs) w
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