Biotech Values

[jaybe]

Why is LDK378 considered 2nd generation ALK?

ORR (Criz-naive) is marginally better than Criz - 62% vs. 60.8%
PFS is less than Criz - 8.6 mos. vs 9.7 mos.
Grade 3/4 AE's are worse than Criz - 37% vs. 18%

Shouldn't "2nd gen" be used for drugs that have significant benefit over first generation. I guess any activity in Criz-resistant population (ORR of 59%) qualifies as 2nd gen until true 2nd gen (like '113) comes online.

I really don't see market share for LDK in Criz-resistant versus '113, and if CH542802 data holds up in Phase 2 for Criz-naive then LDK may go the way of Bosutinib in CML, fighting for last place against a well established 1st generation drug.

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?
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70142-6/abstract

I see Roche has taken over the new Phase 2 trial in Criz-resistant population, the drug is now called RO542802. Maybe it took a year to negotiate the collaboration?
http://clinicaltrials.gov/ct2/show/NCT01871805?term=CH5424802&rank=2