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Exelixis begins mid-stage trial for lung cancer drug

Exelixis has initiated a phase II clinical development program for its investigational drug XL647 in patients with metastatic non-small cell lung cancer.

XL647 is an orally bioavailable small molecule inhibitor of the HER2, EGF, VEGF and EphB4 receptor tyrosine kinases (RTKs). Although these individual RTKs are targets for currently approved therapies, XL647 was designed to potently inhibit all three targets simultaneously.

The trial will be conducted at up to 15 clinical sites in patients with advanced (stage IIIB or IV) non-small cell lung cancer (NSCLC) who have not previously been treated with chemotherapy.

The primary objectives of the study are to determine the response rate and the safety and tolerability of XL647. Secondary objectives include assessment of progression-free survival, duration of response, and overall survival, and characterization of pharmacokinetic and pharmacodynamic parameters of XL647.

“We designed XL647 to potently inhibit EGFR and VEGFR, as well as HER2 and EphB4. We believe that simultaneously inhibiting this spectrum of targets may provide greater efficacy than has been achieved to date by inhibiting these targets individually,” said Dr George Scangos, president and CEO of Exelixis.