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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Again, What's It Worth to You? | Main | Anyone from GSK Interested? »

June 8, 2010

Iplimumab (And Progress Against Cancer)

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Posted by Derek

This time last year, Medarex made all sorts of headlines with their antibody iplimumab. A press release from the Mayo Clinic made it sound like a miracle cure for prostate cancer; the company's stock soared, and they were acquired not long afterwards by Bristol-Myers Squibb. I wrote about iplimumab once, and I still get email from people asking me if I know how they can possibly get some for their relatives with cancer.

As Jim Edwards points out at Bnet, though, this week's ASCO meeting has results for the drug that are more in keeping with what we've come to expect. The antibody had real effects in metastatic melanoma patients, and that's a good thing, because that's a particularly hard situation to show anything useful. (And all too many melanoma patients present after the disease has already gone metastatic, for that matter). From the data that BMS presented, there appears to be no doubt that iplimumab extended survival.

But it did so by three or four months, on average, with some serious adverse events in the treatment group. As I said yesterday, this is the sort of progress that we generally make in oncology, not the oh-my-God-the-cancer-disappeared sort that last year's press release had people thinking about. And again, you can look at this news in two different ways. On the one hand, showing real statistical efficacy against metastatic melanoma is impressive: pretty much everything else we've got does nothing at all. But on the other hand, well. . .three and a half months.

For some people, that's definitely going to be worth it, while for others, they (and their heirs) would be better off not spending the money. That's a very hard decision, one of the hardest, but it is a decision. And either people will make it for themselves, or someone will make it for them. Given the continued emphasis on bringing down the costs of modern medical care - which doesn't look to be going away any time soon - you have to expect that there will be times that governments and/or insurance carriers will say "No, not for that price." Expect? It already happens. But it'll happen more.

This does present a problem for drug discovery. As many commenters noted yesterday, these are the sorts of incremental improvements that can add up in oncology. We're unlikely to hit many miracle-cure home runs, so we have to add a few months here and a few months there, learning as we go, and coming back around with better ideas next time. This takes money - big stacks of it - and we in the industry are expecting people (and their insurance companies, and their governments) to pay up. What if they don't, or not so much?

One thing we could see is companies finding themselves caught out, developing drugs in anticipation of a pricing structure that won't materialize. And it's true that strong pricing pressure will likely slow down progress in the whole field - after all, we don't have any other cheaper ways to develop drugs yet. But that doesn't mean that it couldn't happen. If we want to forestall it, I think we should make clear how incremental and expensive most oncology work is likely to be, and to point out that if there are miracle cures out there, that we're probably not going to find any of them without going through a lot of not-so-miraculous ones first.

Comments (9) + TrackBacks (0) | Category: Cancer | Drug Prices


COMMENTS

1. Anonymous on June 8, 2010 7:29 AM writes...

ipilimumab

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2. Anon on June 8, 2010 7:32 AM writes...

ipilimumab

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3. john on June 8, 2010 7:47 AM writes...

Derek, the design of this trial was a little unusual, in that they used no placebo group. The arms were gp100, gp100+iplimumab, and iplimumab alone. Gp100 is apparently a melanoma antigen that has been used as an experimental vaccine.

A lot of the current thinking in the cancer vaccine area seems to be that the reason most vaccines have not worked is local immune suppression in the vicinity of the tumor. According to this line of reasoning, coadministration of compounds like iplimumab should eliminate this local immune suppression and provide activity.

I think this trial was planned around the idea that iplimumab+gp100 would be a "home run". Instead they ended up with iplimumab alone giving results similar to the combination, and gp100 alone giving results that were arguably worse than those obtained historically with placebo.

So they have a funny set of data to try to interpret. Furthermore, the failure of the iplimumab+gp100 to give better results than iplimumab alone seems to me to be a setback for the whole area of cancer vaccines. Maybe someone with knowledge of this area can comment on this?

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4. john on June 8, 2010 7:49 AM writes...

Oops, I got the name wrong too.

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5. partial agonist on June 8, 2010 8:02 AM writes...

Annon, for ethical reasons pII cancer trials typically have no true placebo group- there is a standard-of-care group. If (as is typical) the test drug is tried as an add-on to an approved therapy, the study arms are approved therapy+test drug and approved therapy (or approved therapies).

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6. partial agonist on June 8, 2010 8:07 AM writes...

Annon, for ethical reasons pII cancer trials typically have no true placebo group- there is a standard-of-care group. If (as is typical) the test drug is tried as an add-on to an approved therapy, the study arms are approved therapy+test drug and approved therapy (or approved therapies).

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7. John on June 8, 2010 8:08 AM writes...

PA, I understand but according to the WSJ article there is no standard of care for late stage melanoma, or at least not one containing gp100.

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8. nucleotide on June 8, 2010 8:15 AM writes...

Tough loss Derek, giving up seven runs in four innings against the D-backs last night...

Maybe you be a reliever in the bullpen instead of a start while working on your blog entries about the trends in the pharmaceutical industry.

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9. RandDChemist on June 8, 2010 9:41 AM writes...

#6 Not sure if it matters, but it was phase III. And the nature of the "placebo" was noted as odd in a few of the reports.

The NYT pieces that was posted a little while ago talks about a few months here and a few months there adding up, at least potentially if more treatments arise.

So a question is, are you buying time, or delaying the inevitable?

One of the issues noted in oncology in a Newsweek feature (from several months ago) on why there has not been better progress is that researchers who get funded are the ones looking for the home runs. Not the singles. The "sexy" science gets funded.

Progress is usually incremental. It's usually not pretty. It's not what anyone wants for cancer treatment, but it is reality.

The echo chambers around the so-called "death panels" seriously damaged a much-needed discussion in the US around end-of-life decisions. If people had good, honest discussions with caregivers, then they have a better opportunity to make sensible decisions that enhance their quality of life. Pallative care was set back by the rhetoric.

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