1. Slide 14 - A prior Phase 1 trial run by AZN randomized 13 uveal (ocular) melanoma patients to temozolomide and 7 to selumetinib. PFS was 50 days for the temozolomide group and 114 days for the selumetinib group with HR of 0.76. About half of uveal melanoma patients have a GNAQ mutation that is sensitive to MEK and AZN did not select patients for this trial based on GNAQ mutation. ARRY believes this subset will have an even greater response to selumetinib. AZN has an ongoing Phase 2 trial of selumetinib vs. temozolomide with ~160 patients with primary endpoint of PFS that is due to complete in June 2012. GNAQ subgroup will apparently be scrutinized in this trial.
A. Phase 2 single agent in BRAF melanoma (~54 patients and enrollment ongoing) B. Phase 1b combo trial of MEK162 and BEZ235 (PI3K/mTOR) in KRAS and EGFR resistant lung tumors (~55 patients and enrollment 2Q11) C. Phase 1b combo trial of MEK162 and RAF265 (RAF) in RAS or BRAFv600e mutation melanoma and pancreatic tumors (~70 patients and enrollment 2Q11).