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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

« Eli Lilly vs. Canada | Main | Another Whack at the Cost of Drugs Issue »

May 1, 2014

Merrimack Wins One

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Posted by Derek

You don't get the chance to say "positive Phase III results in advanced pancreatic cancer" very often, but it looks like Merrimack Pharmaceuticals is able to today. The company has had some real highs and lows over the last few years, but they've made the money hold out long enough to see this. In combination with 5-fluorouracil and leucovorin (but not as a stand-alone), the company MM-398 showed a real increase in survival.

As you might expect, that increase can be looked at more than one way. The standard-of-care group made it for about four months, and the treatment group for about six. You can say "just two months more" or "fifty per cent improvement", as you wish. I hope that I never have to think about advanced pancreatic cancer survival figures in detail, is all I can say. It's worth noting that MM-398 is not some new compound or new mechanism - it's a new way to dose the well-known drug irinotecan, which is already part of the standard regiment for the disease. The company has made a liposomal formulation, and that data would indicate that this really does make a difference. Congratulations to them - that's a very, very tough patient population to see anything happen in.

Comments (8) + TrackBacks (0) | Category: Cancer | Clinical Trials


COMMENTS

1. Dr. Zoidberg on May 1, 2014 8:22 AM writes...

Always good to see some good news in this industry every now and then.

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2. Anonymous on May 1, 2014 9:00 AM writes...

Why wouldn't the control arm include typical dosing/formulation of irinotecan to really show benefit of MM-398?

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3. JIA on May 1, 2014 10:29 AM writes...

I also agree, any kind of news like this is good news in the pancreatic cancer field. I will note, however, that gemcitabine alone (their control arm) is not the standard of care for patients who can tolerate chemo-combo regimens, for example FOLFIRINOX or gemcitabine+Abraxane (nanoparticle albumin-bound nab-paclitaxel). Click link in my handle for more details on the latter: OS of 8.5 months vs 6.7 for gem-alone. It's hard to compare between trials, but it's not clear MM-398 is an improvement. Still, the different side effect profiles will allow doctors more choice in how to treat these very sick patients, so that's a benefit.

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4. anon on May 1, 2014 11:10 AM writes...

I'll bet that the company are hoping that their version of Irinotecan will replace the non-liposomal version in the long run.

One interesting thing from this company is that they have a "diagnostic" for this drug-it's a nanoparticle Fe compound that they say predicts whether a tumour will take up the drug (and I'm guessing they hope that this will predict whether patients will benefit from a course of the drug).

This approach is clearly not new in concept, but we may be at the cusp of being able to subject only those who will benefit from these poisons to the potential side effects. Also, it emphasises how primitive our treatment of solid tumours is at the moment.

Who knows whether this company's approach or another's will be the one that works...

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5. David Young MD on May 1, 2014 11:21 AM writes...

Funny how the FDA does not consider single agent Gemcitibine as the standard-of-care control arm in pancreatic cancer. Well, they did for Abraxane, when Abraxane plus Gemcitibine was somewhat better than Gemcitibine alone for Pancreatic cancer. (or was this a second line study? maybe then the FDA considers Fluorouracil as the standard second line.)

I recall a decade ago when Irofulven was compared to Fluorouracil for the treatment of second line pancreatic cancer. The Fluorouracil arm has an unprecendented excellent response rate and the Irofulven could not beat it... so ultimately the drug was dropped (maybe a good thing, I don't know). But generally, it is not hard to beat single agent Fluorouracil (Leucovorin not really being an anticancer drug) for pancreatic cancer.

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6. Fat Old Man on May 1, 2014 11:23 AM writes...

Some may object to 'old wine in new bottles'. From personal experience ( my wife was on Doxil for a while) I know that the cardio toxicity of doxorubicin disappeared in the liposomal formulation. Why I don't know. But I think quality of life when patients are on drug is worth it.

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7. Slugger on May 1, 2014 2:23 PM writes...

Advances in oncology are always welcome, especially against such a notoriously resistant disease as pancreatic cancer. However, the skeptic in me wonders if doing lots of trials over twentyfive years won't rather inevitably result in a few "significant" p-values. This is especially the case when the improvement is marginal and required more than one study of the new compound, and the fact that the new compound is not that different increases my concerns. Real advances were often seen in the first trials and were spectacular with drugs such as cisplatin in testicular and imatinib in CGL.
Hope I'm wrong and my concerns misplaced.

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8. pharma-zevt on May 1, 2014 9:50 PM writes...

Responding to those asking why not gemcitabine: the company reports that the trial recruited only patients who were already treated with gemcitabine and failed.

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