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NP1986

12/17/11 12:48 AM

#133227 RE: mcbio #133219

3. Slide 26 - BRAF mutant melanoma data

(a) Vemurafenib Phase 3 data - ORR = 48% and mPFS = 5.3 months
(b) selumetinib + DTIC Phase 1b data - ORR = 56% and mPFS = 7.1 months



I'm not sure how much can be garnered from this, especially since it is a comparison between a phase III trial with an n of 337 is being compared with a phase I trial with an n of 9.

Nonetheless, I'm looking forward to the phase II data for selumetinib being presented next year.

In regards to the MEK162 Phase 1 expansion trial in biliary tract cancer patients, ARRY will be presenting results at ASCO GI in January where ARRY has seen PRs and CRs in single-agent trials of MEK162 in a heavily pre-treated patient population. (Someone please listen to the 38 minute mark and let me know if my ears have deceived me; seems pretty clear to me that the presenter said there have been both PRs and CRs seen in this trial. It is of course possible that he misspoke.)



That's what I heard too, and if that's true it does seem quite promising. I'm just surprised he is talking about it before it's been presented at a scientific meeting.
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ghmm

12/17/11 7:22 AM

#133234 RE: mcbio #133219

Thanks for the notes. I looked for the slides yesterday and didn't see them (aside from the presentation but was hoping to download them).

I'll give a plug for http://earningscast.com/calendar/daily for these long presentations (a company like ARRY which I don't follow closely since my position is very small) I like to download which earningscast lets you do (freely at least now) and then I listen at a fast speed with Total Recorder (1.75 usually) which would make the Array presentation only an hour 45 or so :-).

Funny the BMRN I didn't find tedious to listen (watch) and did so a couple times already :-).
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mcbio

01/17/12 8:16 PM

#135244 RE: mcbio #133219

ARRY - MEK162 ASCO GI abstract

[Thanks to Patrick for providing this to me.]

http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=115&abstractID=88653

In particular, in this Phase 1b trial in biliary tract cancer patients, of 26 patients available for response, there was 1 CR, 1 PR, and 11 SD (greater than or equal to 6 weeks). Keep in mind this is single-agent MEK162 treatment. Curious to hear any feedback from the board on this early data.