AstraZeneca (AZN) Reports Selumetinib Phase 3 Missed Primary Endpoint in NSCLC (ARRY)
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AstraZeneca (NYSE: AZN) announced results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC). Array BioPharma (NASDAQ: ARRY) was informed of these results on Monday, August 8, 2016.
The results showed that the trial did not meet its primary endpoint of progression-free survival (PFS), and selumetinib did not have a significant effect on overall survival (OS). The adverse event profiles for selumetinib and docetaxel were consistent with those seen previously.
SELECT-1 is an international trial with 510 randomised patients in over 200 centres. Patients received either selumetinib (75mg, orally, twice daily) or placebo in combination with docetaxel (intravenously, 75mg/m2, on day one of every 21-day cycle).
Selumetinib is being explored as a treatment option in registration-enabling studies in patients with differentiated thyroid cancer where the treatment received Orphan Drug Designation, and patients with neurofibromatosis type 1, a genetic disorder that causes tumours to grow along nerve tissue.1
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