Replies to post #105966 on Biotech Values

[mcbio]

Re: ARRY-380

600mg bid is a LOT of drug. It will be interesting to see how this performs in broader patient populations.

The dose range in the Phase 1 was from 200mg BID up to the MTD of 600mg BID. So, perhaps the drug may be able to be as effective at a dose lower than MTD.

They have a future trial design problem trying to figure out how to deal with T-DM1 in terms of choosing a path to approval. What have they guided for their next trial indication and design?

I don't think management has given a lot of guidance on planned Phase 2 trials. The only specific guidance I know of for the near-term is from the PR regarding the Phase 1 results that ARRY is "conducting an expansion cohort in patients with HER2 positive metastatic breast cancer to confirm safety and explore efficacy and pharmacodynamic markers."

Is it safe to assume that, to ultimately gain approval, ARRY-380 is likely going to have to go head-to-head against T-DM1 and show non-inferiority or superiority? Perhaps ARRY (or hopefully a partner) will test 380 + T-DM1 vs. T-DM1 alone?