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October 30, 2014 at 2:47 pm #22222jeffbGuest
In order to get the Merk PD1, you must have “failed” IPI or Braf.
So what exactly constitutes IPI failure? The easy answer is disease progression. But what about mixed responses and/or “stable” disease? From what I’ve seen from some past postings, if you’ve had a response of some kind to IPI, you can sometimes get a re-infusion after about 6 months, even if your disease is stable or still declining. A booster so to speak.
However, for the Merk PD1, you have to “fail” IPI before you can even get your first PD1 infusion. I have to say this makes no sense at all. Think about it: You can get a re-infusion of a drug with a lesser response rate even if (and maybe especially if) you’re still getting tumor reductions but you can’t get an infusion of a drug with a considerably higher response rate and fewer side effects.
Ok, that’s my rant but I’ve suggested to two people recent who had IPI at least a year ago and have at least stable disease that they check out the Merk PD1. Would they be denied?
Is there a time limit after which you can get the Merk PD1? Say 6 months? Or is that the next step?
JeffOctober 31, 2014 at 3:39 pm #65750JonathanParticipant
I believe anyone who is stable after Ipi is likely to be classified as “unfailed.” Some sort of progression, including a mixed response, is necessary to be classified as “failed.” In my case, I had a positive response to Ipi for 18 months, but then began to show progression again, whereupon I got a second round of Ipi (little response), and even a third one (no response). All this over a 3 year interval. Another year, another experimental chemo, and more progression led to me qualifying for Merck’s Keytruda (first as expanded access beginning in May), and I’m showing a good response to that. I’ll post that story separately.
P.S. It is nuts that Merck’s Keytruda is limited to failed Ipi patients because of the way they initially avoided a large phase III clinical trial. It’s clearly a good drug with an excellent response rate, so why can’t it be approved for first line use? They’re going to have to do a large phase III trial to get that o.k. from the FDA…October 31, 2014 at 5:21 pm #65751Catherine PooleKeymaster
Hang on, the data is coming soon, phase III data from Merck so this awful prerequisite for IPI failure will disappear. I know some docs are working about the rules and I appreciate their commitment to their patients! I heard in the next 6 months this will all change thankfully.November 1, 2014 at 9:52 am #65752JBunyanParticipant Surely a major issue is that of cost? I believe PD1 costs slightly less than double the cost of Ipi, which is already very expensive and out of the reach of the uninsured? I suspect the insurance companies (in US ) and other sponsors (in UK the NHS) are unwilling to fund these very expensive drugs without a “failure” of the cheaper one. It is interesting to a non US citizen to see the US discussions where these wonderful new techniques are often developed, but the cost is rarely mentioned. Are the insurers able to fund this treatment for a wide range of the population?November 1, 2014 at 12:44 pm #65753Catherine PooleKeymaster Sadly, the cost will not be going down on these drugs. And believe me, I am upset at the lack of access for those in other countries. New Zealand still hasn’t approved IPI because of the cost and patients are forced to pay out of pocket there. We can talk about it and be saddened and frustrated but I don’t know the answer. I will post this under another topic area.
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