ASCO Survival Data

Posted by Jeff Berk, BOLT International;


I’m purposely NOT loading lots of Google search terms into this blog, so ONLY my dedicated readers are going to find it and get some free advice.  Not necessarily GOOD advice, but since you’re not paying for it, you’re getting infinitely good value.  Sort of makes my advice priceless, now doesn’t it?

Excuse me for a minute while I send this one last sext.  Okay, where were we?

So… I’m finally out of the dog kennel, back in the cootie cocoon that is a Southworst 737.  Out of Chicago; the Land of Gangsters.  Chicago is going to try to find a trillion dollar solution to their problem of marauding “disadvantaged teens”.  Actually Jefferson already came up with it, and it works really well.  It’s called the 2nd amendment.  Okay, so one anecdote captures the true ambience of the Blowhard City: I got accosted by a community organizer coming out of the Hyatt Regency.  Bullhorn in hand, he was trying to convince me to take up arms against the hotel because of their “brutal working conditions”.  I told the punk to get a job.  He said , “I have a job!” In Scottsdale we don’t consider “union thug” to be a legitimate job description.  But that’s Chicago.  Not a single person earns an honest living there.  Period.  And if you tell me otherwise, you’re a relative or friend of Anthony Weiner.  But back to “punky-poo”, people don’t hassle you like that in Scottsdale.  At least not when you show them a smile that truly comes from the heart, and the stock of a P238HD is poking out of your waistband.


So what can I say about ASCO?  Not a heck of a lot, because you’re not the dude paying my freight (unless you ARE, and you know who you are!).  But once I’ve rambled on for a while, you’ll get the one cherry that I’m going to give up, and you’ll think “that was worth it, even if I had to endure another one of his stupid rants”.

Let me just get some niceties out of the way… The most fun at ASCO, besides seeing ipilimumab 1st line survival data in melanoma, was dinner with Eric Rowinsky, Gene and Julia Saylors.   Eric is one of those high energy ponies.  If you can get on his right side, he’ll eat the carrot out of your hand.  But if you get on the wrong side, or I should say, on the back side, you’re gonna get kicked.  Then Gene and Julia are by far my two favorite hematologists (although I guess Gene is seeing a lot of solid tumors lately).  They both practice in Charleston, SC; Gene’s practice is part of a really high powered money-making mill, and Julia is in a more laid back community setting.  They are the nicest people, and I’m thinking of sending my father down to Gene to get treated for his prostate cancer.   Julia’s brother in law is that new relief pitcher playing for Pittsburgh (sorry he has to be there) but they live in Scottsdale (happy ending!).  I can hit his curve ball, but I don’t want to embarrass somebody half my age.  I really enjoyed meeting some of my blog readers.  It’s great to know that there are people out there who are even more demented than me.  Gregg Riely, it was great to meet you in person, finally.  Loved your IPI-504 study.  And for all the Panelists and a few others, who I could not meet up with in person, ASCO is a zoo.  Everybody knows that.  But you can come visit me in Snottsdale this summer.  Michael Hay (Sagient, BioMedTracker), always a pleasure.  Oh, one more… Ryoma, I hope that the Geiger counter helps.  And that it continues to read “zero”, even once you get home.


And now’s as good a time as any to come clean:  Yes, that is a picture of me on my Facebook page and yes, it is true that I am the one who did in fact post that photograph.  I take full responsibility, but I’m not resigning.


So here we go… BMS had a great meeting.  Not only did they make the case that for melanoma, Yervoy should be used early and often (sort of like Anthony Weiner’s constituents, wouldn’t you say?), but we’re starting to see that immunotherapy with ipilimumab is going to be much broader than just melanoma.  I think what everybody does agree on is that Yervoy is a stupid name.  (But I’m not going to start resorting to stupid name calling).


Overall survival was 11.2 mo on ipilimumab vs 9.1 mo DTIC alone; hazard ratio for death, 0.72; P < .001). 1-year survival was 47.3% on IPI + DTIC vs 36.3% for DTIC monotherapy, 2 years (28.5% vs 17.9%), and 3 years (20.8% vs 12.2%).  So I quote Nick Mulcahy iterviewing Kari Kendra: “The improvement was “not what we had hoped,” Kari Kendra, MD, from Ohio State University in Columbus, told Medscape Medical News. But, she added, the data “still demonstrate that the combination of chemotherapy with [ipilimumab] can enhance survival.””  What?!  Did she actually say that?  Could you please look at the three year survival difference.  For those of you without a calculator, THAT’s A 70% IMPROVEMENT.  Kari, not everybody should get up in front of a microphone.  Just ask…  Anthony Weiner.


BOLT published a Melanoma Thought Leader Panel in the summer of 2010 and we GUARANTEED that the ipilimumab 1st line data would show a survival advantage.  (For those of you who hung in there, I’m just about to mention something worthwhile).  How did we KNOW?  I mean, the trial wasn’t even fully recruited.  Pretty simple actually.  A fart smellow explained this to me some time ago.  He said that all you have to do is count the bodies.  See, with melanoma, you’re going to have a lot of them, and fast.  So last summer my panelists were telling me that there just weren’t enough bodies piling up.  Since we know the mortality rate in the DTIC arm from historical controls, we knew that all of these patients were already dead.  If Ipilimumab + DTIC was only a slight improvement, we would have been seeing some of these deaths as well.  but there weren’t enough.  That had to mean that the patients on ipilimumab weren’t doing a little better.  They had to be doing a LOT better.  Nine months later, this was presented to be the case.



So compare this to Erbitux in colorectal cancer.  You know, the drug that costs $600,000 per QALY?  Do you think that the body count for that trial looked like what I just described?  I’ll give you a hint:  I’ve already done this analysis for a client, and of course it doesn’t.  So what does that mean?  It means that the pharmacoeconomic case for ipilimumab is going to be a lot more credible than the case for Erbitux.  Or, for that matter, you know that when Genentech has that little face-to-face with the P&T committee, there is always a lady in the audience muttering underneath her breath about value equation for Avastin.


So kids, here’s your homework.  Now that you know what to look for, what other trials are going to show a meaningful survival advantage?  Email me and we can compare notes.  Or show some guts and POST your comments.  For all the world to see.  Just like Tony’s sexts, they’ll be there forever!


One of the nice things about getting drunk with practicing oncologists (I was drunk, I’m not saying for sure that they were), is you get to hear about what is really important in their practice.  Saving lives, blah, blah, blah.  Okay, besides that, let me list four of these:


First was the hours and hours per month spent trying to decide how to cut down the million dollars worth of drug inventory that they are carrying.  Do the math.  $1,000,000 at a cost of capital today in the 6% range (I’m being very charitable), and their practice is losing more than $60,000 / yr.  That’s working out to $10,000 per partner.


#2:  Prior authorization doesn’t mean guarantee to pay.  All it means is that the physician is authorized to buy the drug, give it to the patient, and then apply for reimbursement.  Which is declined 5% – 20% of the time, even after prior authorization.  So while money-making Gene’s practice can afford to take some of this risk (but won’t because they KNOW how to make money in this business), community-based Julia’s practice can’t.  For Julia, not getting paid for one Avastin administration is her profit for 20 other Avastin administrations.  So everybody passes these patients off to the hospital, they eat the cost of Avastin for the uninsured patient, and charge the rest of us $100 for a Kleenex.


Here’s the 3rd thing.  Carboplatin is $8/cycle, and oxaliplatin is $8,000/cycle?  As my friend Karen from New Zealand would say, “Are you blinkin’ crazy?”  Actually there, the world spins backwards and I actually agree with Donald Berwick about something: it isn’t worth an extra 37 days of life to put a patient’s family in debt by an extra $40,000.  And if you’re an oncologist and you write that scrip, you’re related to Anthony Weiner.  (Note in editing… I’m sure that by tomorrow I’ll find the flaw in that logic somewhere.  Because if Donald Berwick thinks it, it’s wrong.  That boy is the POSTER CHILD for wiggly-worms in the Obama administration).


Point #4:  Gene gets paid to administer drugs.  In the good old days (days ten years or longer before he started to practice; he’s 35) his partners were making an 8% margin on drugs that they administered.  Gene’s making less than 4% on the drugs he sells.  He HATES to prescribe orals.  For any oral product, he will spend the same two hours working up the patient, and the insurance company will require the patient to purchase through their pharmacy.  Gene won’t see a dime of that.  Nobody’s saying that he chooses to scrip a drug based on these economics, but I’m just sayin’…



Okay, to recap:  BMS rocks with ipilimumab.  And this wasn’t really that hard to see coming.


That’s it for now.  Quit being a lurker (and post something meaningful in response to what you read here).  Or else I’m going to resort calling you “Anthony Weiner”.  Or “wiggly-worm”.




Categories: CANCER, colorectal cancer, melanoma
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