As I initiate this "mental exorcise", I want to start by acknowledging that IMMU has a long history of presenting data on very small populations, and then hyping that data. There was a time and a trading climate when that sort of hype could, and did take the pps to $40.00.
We comfort ourselves with the notion that it is different this time because we have larger patient numbers and we have FDA validation given the breakthrough therapy designation granted IMMU-132 for TNBC. I contend that if things are different, it's in the trading climate and the skepticism with which investors view data coming from IMMU. Let's note that good or bad data, IMMU has never gotten any therapeutic to market in its three decades of existence.
Let's take a closer look at IMMU-132 in TNBC. Here's what Dr G had to say in the November 5th conference call:
"Survival is really key because there's been so many cases in the literature and the product approval that an early start gets a product approved. And it's very rare that the survival data can confirm those early surrogates used for approval.
So, unfortunately, because triple negative breast cancer, in particularly those patients that come into our trial, don't have a good prognosis they usually die very quickly. We're pleased that they're staying alive so long but of course the implication of that is that it will take longer for us to get complete survivor data, which I think is very critical to consider any opportunity for an accelerated approval"
When the Wells Fargo analyst, Matthew Andrews asked when the 80th patient was enrolled in the ph II, Dr. G answered, "probably about four to six weeks ago."
Lets say 5 weeks before that cc held on 11/5/15 gets us roughly to the first day of October, 2015. The results we see on the company presentation were posted as of May 2016. That means, the last patient in the phII for TNBC was enrolled about 7.5 months ago. I had learned from Chau in past conversation that the 60th patient that meets the Ph3 protocol is the same as the 80th (or 83rd patient?). In any event, we know that some portion of the 60 patients that did not achieve an OS event (i.e. did not die), have not reached the interim median OS recently reported as 14.3 months.
Here is what the PI for this study says on this data:
"In this context, the median progression-free survival of 5.6 months observed with IMMU-132 was encouraging, Bardia said, although the results need to be interpreted with caution because the study enrolled a small number of patients and was not randomized to compare IMMU-132 against another drug. Data on overall survival was too immature to be interpretable, he added. "
O.K. So we're just laying some groundwork in order to get a better understanding of where we're at. I'll explore the above, and more, in subsequent posts when I have time to do so. |
