Biotech Values

[mcbio]

The results of the phase II study of perifosine in colorectal cancer were published in JCO:

jco.ascopubs.org/content/early/2011/10/03/JCO.2011.36.1980.abstract

genisi or others: What are your thoughts on the detailed data? Per the link, 38 total mCRC patients receiving 2nd or 3rd-line therapy comprised of perifosine+capecitabine or placebo+capecitabine. Primary endpoint was time to progression and secondary endpoints were OS, ORR, safety, and tolerability. Median TTP was 27.5 weeks for perifosine arm vs. 10.1 weeks for the control arm. That was stat sig at p<.001. Median OS also favored the perifosine arm at 17.7 months vs. just 7.6 months for the control arm. That was also stat sig at p<.0052.

These are extremely positive results, aren't they? Stat sig in such a very small number of patients, in particular for OS, seems very impressive to me. Just wondering if I'm missing something. I guess there's the question if the perifosine arm got mostly 2nd-line patients whereas the control arm got mostly 3rd-line patients. That could of course skew things but I don't know how evenly the arms were actually balanced or if there could even be such a dramatic difference if the arms were widely imbalanced between the 2nd and 3rd-line patients. All told, this seems like very promising data for a PI3K/Akt inhibitor in mCRC.