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AstraZeneca Initiates Phase 3 Clinical Trial For Selumetinib In Non-Small Cell Lung Cancer
Date:10/22/2013

o of 1:1 to receive either selumetinib (75mg, orally, twice daily) or matching placebo in combination with docetaxel (intravenously, 75mg / m2, on day one of every 21 day cycle).  SELECT-1 will be the largest prospective study ever conducted in this patient population, a genetic sub-type of lung cancer associated with poor prognosis and limited treatment options. 

AstraZeneca's decision to progress selumetinib to Phase 3 in NSCLC followed the results from a randomized Phase 2 study evaluating the combination of selumetinib with docetaxel against docetaxel alone in KRAS-mutation positive NSCLC. This study demonstrated a high and durable response rate of 37.2% vs 0% (p<0.0001), translating into a statistically significant improvement in PFS of 5.3 vs 2.1 months (HR 0.58, p<0.014).

Antoine Yver, Vice President and Head of Oncology in AstraZeneca's Global Medicines Development unit said: "To our knowledge, SELECT-1 will be the first Phase 3 study to investigate whether a MEK inhibitor in combination with chemotherapy is superior to chemotherapy alone in advanced or metastatic non-small cell lung cancer.  This is an area of pressing clinical need, and our decision to progress selumetinib was based on Phase 2 results, which showed promising clinical activity in this group of patients." 

AstraZeneca is also investigating the potential for selumetinib in several types of MEK-dependent cancers.  A pivotal Phase 2 study assessing the efficacy and tolerability of selumetinib combined with radioactive iodine (RAI) as adjuvant therapy in patients with differentiated thyroid cancer with high risk of recurrence started in August 2013, and a further Phase 2 study assessing the clinical efficacy and tolerability in combination with dacarbazine in patients with metastatic uveal melanoma is planned to start in late 2013.

About selumetinib
Selumetinib is an oral, potent, selective ME
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SOURCE Array BioPharma
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