After presenting some disappointing data at the spring ASCO meeting, Novartis and Schering AG's tyrosine kinase inhibitor for colon cancer (PTK/ZK) looked to be in trouble. The "CONFIRM-1" trial showed no real benefit from using the drug on top of standard chemotherapy, but "CONFIRM-2" was also underway. That one looked for efficacy in patients who had already failed first-line therapy, and the results are now in: no survival benefit. The financial markets weren't happy, but weren't too surprised - that second trial was a tougher one to reach significance in, given the nature of the patient population.
It's a real whimper of an ending for a drug that some were once touted as the next Avastin. Schering AG kept tossing billion-dollar sales projections around for a while there, and kept trying to put the best face on things even as the bad news started coming in. Their earlier press release on the CONFIRM-1 data, for example, is a model of the Power of Positive Thinking, and is worth a look in light of today's announcement.
It started off with the headline "First results from PTK/ZK CONFIRM 1 trial. . .show positive drug effects in advance colorectal cancer." As you read further, you got to a figure of 17% reduction in risk of disease progression for the combination therapy, as opposed to the standard regimen, "as assessed by investigators." "Assessment by central review," however, showed a 12 per cent reduction, which didn't even reach statistical significance. Halfway down the first page, and the wheels have come off completely, but you'd never know it from reading the bold print at the top.
The chances of PTK/ZK reaching the market have to be close to zero. I know that at one point the companies were looking to go into non-small cell lung cancer, but I wouldn't hold out much hope there, either. As usual when a heavily studied drug candidate goes into the trash, I'd like to remind everyone that all the money that Novartis and Schering AG spent on this, and it was surely a lot, is burned up and gone. This was a Phase III failure, about as expensive as it comes. That cost will be reflected in the price of the next things that either company gets to the market, depend on it. They'll have to make it up somewhere; it's the nature of our industry.
As fate would have it, some other negative clinical data came out today. A study in the New England Journal of Medicine has shown, rather definitively, that the popular herbal supplement echinacea seems to have no effect on colds at all. That's rather in contrast to the signage over on the herbal medicine shelves at my local pharmacy, when I think about it.
Ah, but now that this trial has been run, what are the chances of my being able to go to that drug store next week, next month, next year, and see echinacea promoted as being good for colds? Do I hear. . .close to one hundred per cent? Of course! Herbal medicine companies are made of sterner stuff than we are over here in the artificial non-holistic world. They won't let a little thing like lack of efficacy slow them down.