Biotech Values

[NP1986]

Where do you get that perifosine works specifically in KRAS CRC patients? I thought all their data to date is just in a general mCRC patient population and not specifically targeted to KRAS CRC patients.

KRAS status is probably not predictive of perifosine efficacy, although I don't believe this has been confirmed in clinical trials.

On the other hand, Erbitux and Vectibix don't work in these patients, so anti-EGFR agents are restricted to patients with wild type KRAS. This leaves KRAS mutant patients with limited treatment options once they fail 5FU-based therapy with irinotecan and oxaliplatin.

KRAS testing is now pretty routine in the United States, so it will be possible to tell from the X-PECT trial if perifosine works regardless of KRAS status. If that's the case, then perifosine's market opportunity is significant, IMO.


Reading the publication that genisi kindly alerted us to, the results look quite impressive despite the small size of the study. Both the PFS and OS curves are well separated, and there was a complete response in the perifosine-capecitabine arm as well as three partial responses (compared to one PR in the capecitabine arm).

This was actually part of a larger phase II study which involved patients with other solid tumors, so I don't know if their initial interim analysis controlled for multiple comparisons. But even if they didn't, the p-value for TTP is still quite low.

One issue which could have an impact on the outcome of the phase III study is the dose of capecitabine, which was increased from the 825 mg/m2 dose in the phase II study to 1000 mg/m2 in X-PECT.