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Biotech / Medical : Array Biopharma, Inc

ARRY 8.660

+3.2%

Oct 31 9:30 AM EDT

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To: GregorioAllegri who wrote (320)	1/14/2017 3:20:16 PM
From: GregorioAllegri	of 321

Some Argue for PD-1 inhibitor longevity of action over BRAF/MEK but: Three Year Survival (Percent): Tafinlar + Mekinist: 38% Opdivo: 42% (not clear if this includes Opdivo + Yervoy) Keytruda alone: 40% decisionresourcesgroup.com Quite a bit of toxicity. ARRY's drugs not worse than other BRAF/MEK combos... Comparison with immunotherapies: Percent of patients with Grade 3/4 events encorafenib + binimetinib 58% (leading to 13% discontinuation) Opdivo + Yervoy (Checkmate-067) 56.5 (leading to 30.7% discontinuation) Keytruda + Yervoy (Keynote-029) 42% (leading to 10% discontinuation) Bottom line for BRAF+ melanoma: -Reported PFS for ARRY's drugs are longer than other BRAF/MEK combos and those reported for Opdivo + Yervoy and Keytruda. -Long term survival benefit of PD-1 inhibitors over BRAF/MEK not substantiated by the reported data (they look similar.) -Yervoy adds toxicity to Opdivo and Keytruda. Perhaps they should combine with a MEK inhibitor instead (see ARRY NRAS results, see ARRY pre-clinical slide.) -ARRY drugs have a different safety profile compared to other BRAF/MEK inhibitors. -There are four big pharma companies with commercial products. People will have to believe the increased PFS with the ARRY drugs is real for these products to gain traction. -My experience with ARIA tells me that increased PFS is associated with control of a wider range of BRAF mutants. It also means that as with other TKIs, the earlier the intervention, the better the control (not true with PD-1 inhibitors.) Cancer suppresses DNA repair and thus spawns mutants of the mutants, including those with drug resistance to TKIs. I have not yet seen the mutant spectrum for the BRAF and MEK inhibitors. ARRY has some other irons in the fire, hopefully with less ferocious competition.

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