Ann: IMU Meets Endpoints in Phase 1b Gastric Cancer Trial, page-109

Hi Everyone,

 

My first post in the IMU threads...

 

To give you all some context around the trial results, let me give you a brief run down on my late wife's nightmare:

 

Diagnosed with metastatic HER2+ cancer of the GEJ (gastric cancer; found by accident) at 34 years of age (1 in a million unlucky).

A gastroscopy was required to confirm the primary as stomach tumours aren't visible in CT scans.

The primary was about 40mm (think golf ball) and there were multiple secondary tumours in liver and lungs up to 15+mm in size.

2 x 21-day cycles of ECX (Epirubicin, Cisplatin, and Capecitabine) scans after 42 days showed a partial response; some shrunk but some grew.

8 x 21-day cycles of EOX (Epirubicin, Oxiliplatin and Capecitabine) which showed an exceptional response. No secondary tumours visible in scans. Primary had shrunk by about 95% (think 5 cent piece).

About 6 weeks off treatment then commenced 3 weekly cycles of Herceptin (via a compassionate plan) with Cisplatin (and later Irinotecan)and Capecitabine.

This treatment regime lasted about 28 months before the Herceptin was no longer effective (ie. Herceptin isn't 100% effective against Her2+ gastric cancer.)

About 6 months later her nightmare ended (4 years and 1 week after initial treatment).

 

It's fair to say the results of the trial are promising andI understand why IMU is cautiously optimistic. It is unrealistic to think that all the tumours were going to instantly melt away.  Sure, a vaccine like response results in the body continuing to produce antibodies but we don't know how quick it produces them.  Bear in mind that tumours likely have far greater cell numbers than say, a virus and every antibody produced likely results in the death of a single cell.  The body may need to continually produce antibodies for months/years before the tumorous cells are eradicated from the body (if at all).

 

56 days is almost certainly too short a time period to assess efficacy of the drug. It however appears long enough to confirm toxicity(or lack thereof) whilst also demonstrating some efficacy (which could have been completely as a result of chemo only although unlikely given the increase in antibodies).

 

As has been noted by others, the life expectancy of a HER2+gastric cancer patient is extremely short. An anti HER2+ drug can almost certainly extend the life of a patient fora moderate amount of time or potentially longer. As my wife’s oncologist would point out, cure is unnecessary if the disease can be kept stable (although to be honest, that never really sat well with my wife but she had read on the Herceptin website that it wasn't completely effective against her disease).  The doctor also mentioned he had breast cancer patients that had been on Herceptin for 8-9+ years.

 

Make no mistake, cure isn't the only acceptable result.  I'm almost certain that my late wife would have been happy enough to have had access to a side effect free drug that kept her disease stable for an indefinite period. Herceptin wasn’t side effect free and neither was the chemo… I won’t mention the last 6 months when she had neither except to say it was much worse for her.

 

The outcome that I would be happy to see is that clinical trials show that B cell technology works, that B cell technology results in side effect free treatment and finally the treatment extends life expectancy well beyond the extra couple of years that my wife got from Herceptin.  If that was achieved or at least if a big pharma concluded that that was what was going to be achieved, I would not be surprised to see a T/O offer for around $1 per share ($4.6 Billion dollars). I think any offers below 50c would result in a bidding war which could well drive the price well over $1. Whilst I would like it to occur sooner rather than later whatever the case, I don't think it'll come before Phase 2results are known and there is a really good understanding of how effective the treatment and the B Cell platform will be.

 

Good luck to the scientists involved and also us shareholders. (I won't say good luck to all the cancer suffers because sadly it's almost certain they will be long gone before this drug hits the market.)