Replies to post #162579 on Biotech Values

[biomaven0]

Why is LDK378 considered 2nd generation ALK?

Because it has dramatically better potency against ALK than does criz, and it is effective in some patients that failed criz. Its potency is in the same general ballpark as '113.

You really can't compare across trials like you are doing - the patient populations can be very different.

Peter

[jq1234]

LDK378 ORR (Criz-naive) is marginally better than Criz - 62% vs. 60.8%
PFS is less than Criz - 8.6 mos. vs 9.7 mos.

Really different population, can't be compared directly. Xalkori data came from a trial that included patients who never received any chemo, while majority patients in LDK trial, 79 out of 114, were Xalkori resistant, thus much sicker population in general. For comparison, Xalkori in another trial listed on label that included only previous treated patients had both lower ORR 50% and DOR. Thus even though these patients are ALK+, how many non ALK inhibitor treatments previously received - how sick these patients are - do affect efficacy. You have to look at patient population first before you compare results cross trials.

By the way why does the Chugai data from ASCO include responses from the same 43 of 46 patients with data cut-off of July 31, 2012. Not that there's anything wrong with publishing year old data at ASCO, but if 93% OR is accurate why wait a year to start Phase 2 trial?

They hadn't enrolled any new patients, just resported same response data reached before with updated DOR which currently is at 13 months and ongoing. It takes longer to get to mDOR for ALK naive patients. They didn't wait a year to start ph2, the 46 patients enrolled are from ph2. Roche started ph1 in ALK resistant trial one year ago, is going to start a ph2 in both ALK resistant and chemo doublet treated population. I assume they are going to file AA based on this ph2. Chugai is majority owned by Roche. They are also planning for ALK naive ph3 trial.