Biotech Values

[poorgradstudent]

My point with the BIOM data is that it can be easy to dismiss impressive prior data *knowing* that the follow-up failed. However, had you read BIOM's phase II data at the time of its release, would you have invested?

One thing to keep an eye on for tesmilifine: it's noted to enhance chemotherapy cytotoxicity possibly by modulating p450 or interfering with MDR. If that's the case, my little mind suggests that an arm with cytotoxic X + tesmilifine should have a higher response rate than the cytotoxic alone. This is likely to be accompanied by higher toxicity for the cytotoxic + tesmilifine arm.

I note that from the JCO paper, tesmilifine did not increase the number of objective responses but did increase toxicity (note that an MDR inhibitor has failed phase III NSCLC due to toxicity). Also interesting is that the ASCO abstract for this trial suggests that an interim analysis looking for increased response rate failed to show it, but did show increased toxicity.

The other red flag with the phase III described in the JCO article is that overall survival was increased by the addition of tesmilifine without an increase in PFS. If this increased survival is a drug effect attributable to tesmilifine, then why isn't PFS significantly increased? As described (if you imagine the kaplan-meier curves), the data suggests a long-term survival bias for the tesmilifine arm well past the time that treatment ended... which begs the question about patient treatment following their progression *off* the trial. I haven't had time yet to comb over the JCO paper, so these questions may be answered. If not, they may be reason for caution.

This used to be a Bristol Myers drug? Any idea how it landed into YM's lap? Interesting to note that BMS is in the ASCO abstract, but their name is missing from the JCO publication. Did they drop it for toxicity?