Biotech Values

[DewDiligence]

Re Squalamine in NSCLC:

Thanks, Randy, for digging up those NSCLC results. (For “thread tracking” purposes, your post #1871 is a reply to #1833: #msg-2863014.)

In the Hainsworth study you cited, we can employ linear interpolation (accurate enough for our purposes) to approximate the median survival. Using linear interpolation, the duration of time until 50% of patients are alive is 5/6 of the duration of time until 40% are alive, which we know is one year. Hence the approximate median survival in this trial is 5/6 years or 10 months. This is almost exactly the median survival in the Iressa trials you cited for the patients who received chemo only. (You said “mean” survival but I assume you meant to say “median”.)

Hence, we have data from approximately 1,300 stage-3b/4 NSCLC patients in three distinct trials giving a median survival of about 10 months for treatment with Paclitaxel and Carboplatin. It therefore seems reasonable to use this 10-month median survival as the historical chemo-only control for GENR’s NSCLC trial in which Squalamine was added to Paclitaxel and Carboplatin.

>> [Randy]: I would guess that if we lower the chemo dosage and keep survival rates in line with these survival rates that someone will have an interest in taking this on to additional trials. <<

I am somewhat more pessimistic than you are. I think Squalamine will have to show a survival advantage relative to the 10-month historical value to receive funding (from GENR or someone else) for additional trials. My best guess is that a median survival of 12 months (a 20% and 2-month improvement) is the minimum to justify continuing the clinical program.

The fact that the chemo dose in the Squalamine trial was less intensive than what is typically given to NSCLC patients in this setting is beneficial in terms of making the treatment more tolerable, but this is not sufficient in its own right to justify continuing the program without a survival benefit, IMHO. The chemo-reduction benefit in the Squalamine trial is one of timing –spreading the chemo over weekly rather than tri-weekly infusions—but the cumulative amount of chemo given during a course of treatment is the same.

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What do the scientists, oddsmakers, and pundits think is the probability that Squalamine will be able to add two months to the median survival? Feel free to chime in…