Biotech Values

[mcbio]

Re: ARRY-520 Phase 1 ASH results

The # of responses only differs by an additional PR from ASCO 2010 and seems a bit underwhelming but this is a single agent trial.

Did you see the Seeking Alpha article I posted before from Ohad Hammer regarding ARRY (#msg-55157672)? In that, he touches on what to look for with the 520 results. In particular, he said that the "unofficial efficacy bar for new drugs in this setting [relapsed/refractory MM patients] is a response rate of ~25% with a median duration of response of ~6 months..." My main question is in what context is he referring to response rate here? If we go by the ASH poster that you linked to on ARRY's Web site, of 30 patients, there were 2 PRs, 2 minimal responses, and 8 patients with SD or better for >6 months. Does response rate used in the article refer to those patients who have at least a PR and have SD for >6 months, does it refer to patients who at least have a PR and/or SD for >6 months, or does it only refer to those patients that have at least a PR regardless of SD? If Hammer's reference in referring to response rate is both patients who have at least a PR and/or have SD >6 months, then the response rate for ARRY-520 would be 8/30 I believe (I'm including the 2 PR patients within the 8 SD patients and not counting them separate), or ~26%, which would appear to be a success for the drug. If we only count the 2 PRs, then we're only talking about 2/30 patients, or a 6% response, which would clearly be underwhelming and would mean the drug may likely only have the potential to be viable in a combo trial with Velcade.