Exelixis Reports Encouraging Interim Data From a Phase 2 Trial of XL647 as First-Line Therapy for Non-Small Cell L...( - Clinical benefit observed in ...)

- Clinical benefit observed in over 60% of evaluable patients -

SEOUL, South Korea, Sept. 4 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL) today reported interim data from an ongoing phase 2 trial evaluating XL647 as first-line therapy for patients with non-small cell lung cancer (NSCLC). This open-label phase 2 trial is ongoing in previously untreated patients with stage IIIB or IV NSCLC who have adenocarcinoma histology and meet one of the following three criteria: Asian descent, female gender, or no or minimal smoking history. XL647 is administered orally, at a dose of 350 mg on Days 1-5 of repeated 14-day cycles.

To date, over 60% of evaluable patients in the phase 2 study have had partial responses (PR) or stable disease (SD) as their best response. Importantly, responses have been observed in patients with and without activating mutations in the epidermal growth factor receptor (EGFR), a target of XL647. Activating mutations in EGFR have been associated with improved sensitivity to other EGFR inhibitors. Dr. Shirish Gadgeel of Karmanos Cancer Institute at Wayne State University presented the data today in a poster (Abstract P3-136) at the 12th International Association for the Study of Lung Cancer World Conference on Lung Cancer, which is being held in Seoul, South Korea.

Key data points reported by Investigators:

-- XL647 has demonstrated anti-tumor activity in patients with previously

untreated NSCLC: >60% of evaluable patients experienced clinical

benefit as their best response (8 PR and 11 SD out of 30 evaluable

patients).

-- Of the 8 patients who experienced partial responses, 4 had EGFR exon 19

deletions, 1 had an EGFR L858R mu
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