1. Linkmeister on June 7, 2004 4:06 PM writes...

knuckle-dragging throwback

Missed opportunity to use "troglodyte."

2. imclonite100 on June 9, 2004 11:31 PM writes...

Wonderful. Stocks go up as long as there are still incorrect skeptics.

Let's just address H&N.

a) newly diagnosed patients per year are NOT the only target market. That market is most living with H&N which was not eradicated surgically.

b) 30% of patients now already take only RT and not chemo, despite the fact that chemo has proven survival benefits here. It is because the chemo regime also have proven harsh toxicity.

To imagine that the market for Erb is hence only some subset of this 30% is silly----a significant number of those taking chemo now may decide to switch to Erb on account of a significantly greater quality of life.

The real issue though is that the H&N results will accelerate marketing in colorectal, a significantly larger market.

The idea is that good cancer drugs tend stay looking good across multiple trials. Physicians will now assume that the 2nd line Erb trials in CRC will probably give survival or TTDP benefit.

I'm sure this guy would have similarly predicted a maximum $250 million/year market for Rituxan, as quite a number of people did upon its introduction. At present, Rituxan is the single largest selling drug for Genentech, giving $1.5 B/yr---and more overseas (but that goes to Roche, as MabThera). And that's almost all for one disease, Non_hodgkin's lymphoma (which is really many different related diseases).

CRC plus H&N are much bigger (but there is more competition too).

And Icahn is cashing in some, but not all of his stake. If he thought it were dangerously overvalued he would have sold it all.

Oh notice in his blog---he "lost money on Imclone"....sounds like he had a bad experience in the past (as many others had).

3. imclonite101 on June 9, 2004 11:34 PM writes...

Combined modality of chemo-radiation in locally advanced head and neck (and lung) is one of the most toxic regimens an oncologists can recommend to a patient.

100% of patients will experience horrible mucositis-esophagitis. Many oncologist recommend placement of a percutaneous feeding tube before treatment is started. Despite this, most will require hospitilization at some point in their treatment, sometimes weeks at a time. Parenteral nutrition is often required. Oncologists hate to prescribe this treatment.

Those who do well with chemo-XRT treatment ,over time, may develop esophageal strictures requiring periodic endoscopic balloon dilatation, with risk of esophageal perforation.

Without a doubt, when given the choice between these two treatment modalities of chemo-XRT vs Erbitux-XRT, oncologist will favor the later, because the side effect is so much better.....and efficacy at least equivilent.

4. imcl on June 9, 2004 11:37 PM writes...

Summary:
While the results of yesterday's presentation of radiotherapy with and
without Imclone (IMCL), Bristol-Myers Squibb (BMY) and Merck KgaA's (MRK GR)
Erbitux (cetuximab) in head and neck cancer appear seemingly good, a few
items caught our attention and cause us to restrain our enthusiasm.

Study conduct appears to be relatively good though limited visibility on
critical items like the exact method that locoregional control was evaluated.
Analysis is early with only 50% of the expected progression events thus far
having occurred and results like this are subject to change with additional
events.

If these results pan out, substantial integration into other head and neck
cancer settings in which radiotherapy is the standard of care, will be
investigated with the largest potential of these being the adjuvant setting
following surgical resection

Despite Erbitux's apparent success in combination with radiotherapy, which is
a squamous histology, we remain cautious about Erbitux in combination with
chemotherapy in adenocarcinoma of the colon.

We anticipate that tumors of the head and neck region will gain interest of
translational scientists as the epidermal growth factor receptor (EGFR) of
responders and longer survivors will be studied at the molecular level.
However, we do not envision such results impacting on the use or the label of
Erbitux.
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Based on the results on the presentation of the phase 3 study of radiotherapy
and Erbitux (cetuximab) in head and neck cancer, we emphasize that there is no
guarantee that the Food and Drug Administration (FDA) will seriously consider
this study for registration. While we have been less optimistic about the
outcome of this trial than the results appear to show, we note that more
mature results could trend toward lesser significance and potentially hamper a
supplemental registration of Erbitux in this setting of head and neck cancer.

Reasonable Study Design; Survival Not the Primary Efficacy Endpoint

The study enrolled patients with advanced head and neck squamous cell
carcinoma who were deemed not candidates for surgery or chemotherapy.
Approximately 200 patients were enrolled on each arm yielding a planned 90%
power to detect a 50% difference in locoregional progression and an 80% power
to detect a 50% difference in survival. The conventional log-rank test
statistic was prospectively selected and the type 1 error was chosen as the
standard two-sided 0.05.

Patients received either radiotherapy alone (in one of three fractionation
schemes) or radiation in combination with the approved dose and schedule of
cetuximab for colon cancer, for eight weeks. At progression, patients were
allowed to receive additional salvage therapy including neck dissection,
salvage surgery, additional radiotherapy or chemotherapy.

Arms Well-Balanced: Increased Confidence in Results