Merck’s PD1 Approved by FDA

At the recommended dose of 2mg/kg given every three weeks, $12,500/month which works out to $150,000 for a full year.

Joe

At the recommended dose of 2mg/kg given every three weeks, $12,500/month which works out to $150,000 for a full year.

Joe

At the recommended dose of 2mg/kg given every three weeks, $12,500/month which works out to $150,000 for a full year.

Joe

It means " too bad " for those who do not fit the criteria.

The object of this is to smear Bristol Meyers Yervoy and steal market share away in this billion dollar game.

Why else would there be a stipulation that you had to have a "failed response to Bristol Meyer's Yervoy" , other than to taint the perception of the Bristol Meyer product and give themselves an edge.

Quite frankly, it's disgusting. I can only get the treatment if I failed on a competitor's product ?  Outrageous.

They had to beat Bristol Meyer to the market because Bristol Meyer has a follow up treatment about to be approved also. Their follow up anti pd1 treatment has had fantastic results, especially when used after, or with Yervoy. 

Bristol Meyer forced Merck's hand.

Whoever gets to market first, gets a huge advantage in this high stakes game of cancer treatment.

shane

It means " too bad " for those who do not fit the criteria.

The object of this is to smear Bristol Meyers Yervoy and steal market share away in this billion dollar game.

Why else would there be a stipulation that you had to have a "failed response to Bristol Meyer's Yervoy" , other than to taint the perception of the Bristol Meyer product and give themselves an edge.

Quite frankly, it's disgusting. I can only get the treatment if I failed on a competitor's product ?  Outrageous.

They had to beat Bristol Meyer to the market because Bristol Meyer has a follow up treatment about to be approved also. Their follow up anti pd1 treatment has had fantastic results, especially when used after, or with Yervoy. 

Bristol Meyer forced Merck's hand.

Whoever gets to market first, gets a huge advantage in this high stakes game of cancer treatment.

shane

I don't know Shane. Maybe Tim can shed some light on why it is set up like it is. Why would you require a patient to use your competitor's product before they can use your's if you are solely concerned with market share. Strictly on a business decision I would want the customer to use my product first and only my product. 

I don't know Shane. Maybe Tim can shed some light on why it is set up like it is. Why would you require a patient to use your competitor's product before they can use your's if you are solely concerned with market share. Strictly on a business decision I would want the customer to use my product first and only my product. 

I don't know Shane. Maybe Tim can shed some light on why it is set up like it is. Why would you require a patient to use your competitor's product before they can use your's if you are solely concerned with market share. Strictly on a business decision I would want the customer to use my product first and only my product. 

I don't think the "prior ipi" requirement was Merck's choice in an attempt to make BMS look bad.  It's a complicated situation for sure.  After having ipi on the market for only about three years, BMS themselves were probably fuming at the prospect of Merck getting accelerated approval (without completing their Phase III trial) for pembro and taking a huge chunk out of BMS' ipi revenue.  At the same time, BMS can't scream too loudly, because they'd love for nivo to get the same accelerated approval (they're supposedly going to submit for approval in the next few months), even though it will also eat into their ipi revenue — in other words, they'd much rather not lose any ipi revenue, but if they're going to, they'd prefer to lose it to another of their own products.  A cynic might wonder how hard BMS would have pushed nivo development, in order to protect ipi for a few more years, if Merck didn't have pembro, but I'll give them the benefit of the doubt.  There will be a big effort by BMS on the ipi/nivo combo front, I'm sure.  Again, a complicated situation, especially for BMS, and hence for the FDA.  As a patient, it's frustrating to say the least, but I also recognize that these companies are in business and drug development isn't cheap — not only the cost to develop them, but run trials, get approvals, etc.  Then factor in the development costs of drugs that don't make it to market, that have to be recouped somehow.  I'm neither a critic or defender of the industry, only a very interested observer who doesn't see an easy answer.

With regards to my earlier questions, thinking a little further, I imagine the "at least two doses of ipi" requirement is to prevent someone from purposefully receiving the minimal dose with the sole intent of satisfying the requirement before moving on to pembro.  If a patient has to discontinue due to adverse side-effects, I think a doctor could still prescribe it off-label, at which point it would be up to the insurance company to approve it with extenuating circumstances.  Again, not ideal, but I'm guessing that's how it will be.  

The same goes for the "disease progression within six months" of ipi requirement.  Again, I believe at that point a doctor could prescribe it off-label, but the justification to the insurance company might be more of a challenge.  At $120K for another 12-week course of ipi (after having already spent $120K for a first course), one wonders what an insurance company might decide compared to the cost of pembro, which will have an indeterminant cost based on if and for how long the patient responds to pembro.

Hopefully this all changes quickly.  Once the final Phase III results are submitted to and reviewed by the FDA (not sure exactly where that stands), the FDA will lift these prior therapy requirements and make it a first-line treatment option alongside ipi and the BRAF agents.

Exciting news today, but still plenty to navigate for anyone facing treatment decisions.

I don't think the "prior ipi" requirement was Merck's choice in an attempt to make BMS look bad.  It's a complicated situation for sure.  After having ipi on the market for only about three years, BMS themselves were probably fuming at the prospect of Merck getting accelerated approval (without completing their Phase III trial) for pembro and taking a huge chunk out of BMS' ipi revenue.  At the same time, BMS can't scream too loudly, because they'd love for nivo to get the same accelerated approval (they're supposedly going to submit for approval in the next few months), even though it will also eat into their ipi revenue — in other words, they'd much rather not lose any ipi revenue, but if they're going to, they'd prefer to lose it to another of their own products.  A cynic might wonder how hard BMS would have pushed nivo development, in order to protect ipi for a few more years, if Merck didn't have pembro, but I'll give them the benefit of the doubt.  There will be a big effort by BMS on the ipi/nivo combo front, I'm sure.  Again, a complicated situation, especially for BMS, and hence for the FDA.  As a patient, it's frustrating to say the least, but I also recognize that these companies are in business and drug development isn't cheap — not only the cost to develop them, but run trials, get approvals, etc.  Then factor in the development costs of drugs that don't make it to market, that have to be recouped somehow.  I'm neither a critic or defender of the industry, only a very interested observer who doesn't see an easy answer.

With regards to my earlier questions, thinking a little further, I imagine the "at least two doses of ipi" requirement is to prevent someone from purposefully receiving the minimal dose with the sole intent of satisfying the requirement before moving on to pembro.  If a patient has to discontinue due to adverse side-effects, I think a doctor could still prescribe it off-label, at which point it would be up to the insurance company to approve it with extenuating circumstances.  Again, not ideal, but I'm guessing that's how it will be.  

The same goes for the "disease progression within six months" of ipi requirement.  Again, I believe at that point a doctor could prescribe it off-label, but the justification to the insurance company might be more of a challenge.  At $120K for another 12-week course of ipi (after having already spent $120K for a first course), one wonders what an insurance company might decide compared to the cost of pembro, which will have an indeterminant cost based on if and for how long the patient responds to pembro.

Hopefully this all changes quickly.  Once the final Phase III results are submitted to and reviewed by the FDA (not sure exactly where that stands), the FDA will lift these prior therapy requirements and make it a first-line treatment option alongside ipi and the BRAF agents.

Exciting news today, but still plenty to navigate for anyone facing treatment decisions.

I don't think the "prior ipi" requirement was Merck's choice in an attempt to make BMS look bad.  It's a complicated situation for sure.  After having ipi on the market for only about three years, BMS themselves were probably fuming at the prospect of Merck getting accelerated approval (without completing their Phase III trial) for pembro and taking a huge chunk out of BMS' ipi revenue.  At the same time, BMS can't scream too loudly, because they'd love for nivo to get the same accelerated approval (they're supposedly going to submit for approval in the next few months), even though it will also eat into their ipi revenue — in other words, they'd much rather not lose any ipi revenue, but if they're going to, they'd prefer to lose it to another of their own products.  A cynic might wonder how hard BMS would have pushed nivo development, in order to protect ipi for a few more years, if Merck didn't have pembro, but I'll give them the benefit of the doubt.  There will be a big effort by BMS on the ipi/nivo combo front, I'm sure.  Again, a complicated situation, especially for BMS, and hence for the FDA.  As a patient, it's frustrating to say the least, but I also recognize that these companies are in business and drug development isn't cheap — not only the cost to develop them, but run trials, get approvals, etc.  Then factor in the development costs of drugs that don't make it to market, that have to be recouped somehow.  I'm neither a critic or defender of the industry, only a very interested observer who doesn't see an easy answer.

With regards to my earlier questions, thinking a little further, I imagine the "at least two doses of ipi" requirement is to prevent someone from purposefully receiving the minimal dose with the sole intent of satisfying the requirement before moving on to pembro.  If a patient has to discontinue due to adverse side-effects, I think a doctor could still prescribe it off-label, at which point it would be up to the insurance company to approve it with extenuating circumstances.  Again, not ideal, but I'm guessing that's how it will be.  

The same goes for the "disease progression within six months" of ipi requirement.  Again, I believe at that point a doctor could prescribe it off-label, but the justification to the insurance company might be more of a challenge.  At $120K for another 12-week course of ipi (after having already spent $120K for a first course), one wonders what an insurance company might decide compared to the cost of pembro, which will have an indeterminant cost based on if and for how long the patient responds to pembro.

Hopefully this all changes quickly.  Once the final Phase III results are submitted to and reviewed by the FDA (not sure exactly where that stands), the FDA will lift these prior therapy requirements and make it a first-line treatment option alongside ipi and the BRAF agents.

Exciting news today, but still plenty to navigate for anyone facing treatment decisions.

Posting a correction to one of my posts from last week.  In the Merck press release at:

http://www.mercknewsroom.com/news-release/oncology-newsroom/merck-receives-accelerated-approval-keytruda-pembrolizumab-first-fda-

I noted that Merck had a two-dose minimum of prior Yervoy and disease progression within six months of completing Yervoy to be eligible for pembro (Keytruda).  In another thread eariler today, someone pointed out that this was criteria used for the study which was used for the approval, but there's no indication that these criteria are in effect for the approved use.  Here's the section I was referencing:

"The approval of KEYTRUDA was based on data from a multi-center, open-label, randomized, dose-comparative study cohort of the ongoing KEYNOTE-001 Phase 1b trial in patients with unresectable or metastatic melanoma and progression of disease. Key eligibility criteria included prior treatment with ipilimumab (two or more doses at 3 mg/kg or higher) and a BRAF or MEK inhibitor, if BRAF V600 mutation positive; and disease progression within 24 weeks following the last dose of ipilimumab."

When it was pointed out to me and I reread it, I see that the first sentence notes that these were the criteria for the kEYNOTE-001 Phase 1b trial.  To be clear, prior ipil and BRAF or MEK (for BRAF-positive patients) is still required, but it would appear that the two dose minimum and disease progression within 24 months of ipi are not included in the final approval.

My sincere apologies and thanks to "evleye" for pointing this out,
Joe

Posting a correction to one of my posts from last week.  In the Merck press release at:

http://www.mercknewsroom.com/news-release/oncology-newsroom/merck-receives-accelerated-approval-keytruda-pembrolizumab-first-fda-

I noted that Merck had a two-dose minimum of prior Yervoy and disease progression within six months of completing Yervoy to be eligible for pembro (Keytruda).  In another thread eariler today, someone pointed out that this was criteria used for the study which was used for the approval, but there's no indication that these criteria are in effect for the approved use.  Here's the section I was referencing:

"The approval of KEYTRUDA was based on data from a multi-center, open-label, randomized, dose-comparative study cohort of the ongoing KEYNOTE-001 Phase 1b trial in patients with unresectable or metastatic melanoma and progression of disease. Key eligibility criteria included prior treatment with ipilimumab (two or more doses at 3 mg/kg or higher) and a BRAF or MEK inhibitor, if BRAF V600 mutation positive; and disease progression within 24 weeks following the last dose of ipilimumab."

When it was pointed out to me and I reread it, I see that the first sentence notes that these were the criteria for the kEYNOTE-001 Phase 1b trial.  To be clear, prior ipil and BRAF or MEK (for BRAF-positive patients) is still required, but it would appear that the two dose minimum and disease progression within 24 months of ipi are not included in the final approval.

My sincere apologies and thanks to "evleye" for pointing this out,
Joe

Posting a correction to one of my posts from last week.  In the Merck press release at:

http://www.mercknewsroom.com/news-release/oncology-newsroom/merck-receives-accelerated-approval-keytruda-pembrolizumab-first-fda-

I noted that Merck had a two-dose minimum of prior Yervoy and disease progression within six months of completing Yervoy to be eligible for pembro (Keytruda).  In another thread eariler today, someone pointed out that this was criteria used for the study which was used for the approval, but there's no indication that these criteria are in effect for the approved use.  Here's the section I was referencing:

"The approval of KEYTRUDA was based on data from a multi-center, open-label, randomized, dose-comparative study cohort of the ongoing KEYNOTE-001 Phase 1b trial in patients with unresectable or metastatic melanoma and progression of disease. Key eligibility criteria included prior treatment with ipilimumab (two or more doses at 3 mg/kg or higher) and a BRAF or MEK inhibitor, if BRAF V600 mutation positive; and disease progression within 24 weeks following the last dose of ipilimumab."

When it was pointed out to me and I reread it, I see that the first sentence notes that these were the criteria for the kEYNOTE-001 Phase 1b trial.  To be clear, prior ipil and BRAF or MEK (for BRAF-positive patients) is still required, but it would appear that the two dose minimum and disease progression within 24 months of ipi are not included in the final approval.

My sincere apologies and thanks to "evleye" for pointing this out,
Joe

Trial approval and FDA approval processes are complicated. To get approval (and funding) for trials they have to meet certain criteria because the idea is to try and determine better therapies both overall for patients but also how better to tailor therapy for the individual. Also keep in mind that pretty much any new drug in trial is going to require that FDA approved therapies be attempted before enrollment. Many of the previously approved therapies do work well for people and should not be discounted just because there's a new drug in development.

In the Merk press announcement they also noted that they are still undergoing phase II and III trials with the drug (I didn't read that carefully, but these are likely in combo with Yervoy and/or other FDA approved therapies) so there are still likely opportunities to get the drug if you haven't been through/failed the other therapies. We all get a bit impatient sometimes wanting the most recent, most exciting thing coming down the pipe. 

I certainly understand the frustration, but at least it has approval and is now (or will be soon) available outside of tirals and EAPs

One step at a time, and couldn't have come at a better time for me!

-Eva

Trial approval and FDA approval processes are complicated. To get approval (and funding) for trials they have to meet certain criteria because the idea is to try and determine better therapies both overall for patients but also how better to tailor therapy for the individual. Also keep in mind that pretty much any new drug in trial is going to require that FDA approved therapies be attempted before enrollment. Many of the previously approved therapies do work well for people and should not be discounted just because there's a new drug in development.

In the Merk press announcement they also noted that they are still undergoing phase II and III trials with the drug (I didn't read that carefully, but these are likely in combo with Yervoy and/or other FDA approved therapies) so there are still likely opportunities to get the drug if you haven't been through/failed the other therapies. We all get a bit impatient sometimes wanting the most recent, most exciting thing coming down the pipe. 

I certainly understand the frustration, but at least it has approval and is now (or will be soon) available outside of tirals and EAPs

One step at a time, and couldn't have come at a better time for me!

-Eva

Trial approval and FDA approval processes are complicated. To get approval (and funding) for trials they have to meet certain criteria because the idea is to try and determine better therapies both overall for patients but also how better to tailor therapy for the individual. Also keep in mind that pretty much any new drug in trial is going to require that FDA approved therapies be attempted before enrollment. Many of the previously approved therapies do work well for people and should not be discounted just because there's a new drug in development.

In the Merk press announcement they also noted that they are still undergoing phase II and III trials with the drug (I didn't read that carefully, but these are likely in combo with Yervoy and/or other FDA approved therapies) so there are still likely opportunities to get the drug if you haven't been through/failed the other therapies. We all get a bit impatient sometimes wanting the most recent, most exciting thing coming down the pipe. 

I certainly understand the frustration, but at least it has approval and is now (or will be soon) available outside of tirals and EAPs

One step at a time, and couldn't have come at a better time for me!

-Eva

It means " too bad " for those who do not fit the criteria.

The object of this is to smear Bristol Meyers Yervoy and steal market share away in this billion dollar game.

Why else would there be a stipulation that you had to have a "failed response to Bristol Meyer's Yervoy" , other than to taint the perception of the Bristol Meyer product and give themselves an edge.

Quite frankly, it's disgusting. I can only get the treatment if I failed on a competitor's product ?  Outrageous.

They had to beat Bristol Meyer to the market because Bristol Meyer has a follow up treatment about to be approved also. Their follow up anti pd1 treatment has had fantastic results, especially when used after, or with Yervoy. 

Bristol Meyer forced Merck's hand.

Whoever gets to market first, gets a huge advantage in this high stakes game of cancer treatment.

shane

Pembrolizumab works just as well as a first line treatment — I wonder if  doctors will be able to get it 'Off Label" soon? And if insurance companies would help cover the cost?  

Pembrolizumab works just as well as a first line treatment — I wonder if  doctors will be able to get it 'Off Label" soon? And if insurance companies would help cover the cost?  

Pembrolizumab works just as well as a first line treatment — I wonder if  doctors will be able to get it 'Off Label" soon? And if insurance companies would help cover the cost?  

Sadly, the data is very clear that anti-PD1 products work much better in treatment naive patients.  Hopefully, studies that continue to demonstrate that, like those published this year at ASCO, will allow docs to pressure all companies involved….insurance and manufacturers…to gain approval and payment for use as they see fit BEFORE patients are forced to fail both ipi and BRAFi. 

Yet, at least it is a step forward toward needed treatment for some.  Thanks to all the ratties out there who made it happen!!!  Best – c

Sadly, the data is very clear that anti-PD1 products work much better in treatment naive patients.  Hopefully, studies that continue to demonstrate that, like those published this year at ASCO, will allow docs to pressure all companies involved….insurance and manufacturers…to gain approval and payment for use as they see fit BEFORE patients are forced to fail both ipi and BRAFi. 

Yet, at least it is a step forward toward needed treatment for some.  Thanks to all the ratties out there who made it happen!!!  Best – c

Well Celeste, I like to think of myself more alone the lines of a mouse than a rat. It is nice to see that we can all find something to debate after this wonderful news from Merck today. Being a mouse, from the BMS labs side of things has some advantages, mainly price tag, wow that is big bucks if you don't have coverage. My first thought about price, was will they charge by the Kilo and if so I am sure glad I am on the trial, otherwise I would need to go on a diet ASAP.  Here is something to think about, if the BMS trial of Ipi combined with Nivolumab get approved in the near future will insurance companies cover it ?  The trial that I am on has 4 doses of Ipi over 12 weeks and Nivolumab every two weeks for 2 years, I wonder what that price tag would look like?  My understanding is the big target for BMS is lung cancer approval with the combination. My stats might be off a little but I think there are around 200, 000 patients a year for lung cancer vs maybe 10,000 for melanoma. My last comment on the topic is ," boy I am sure glad these drugs are working." Stage 4 with brain and lung mets summer of 2013 and still here!!!!  Ed

Well Celeste, I like to think of myself more alone the lines of a mouse than a rat. It is nice to see that we can all find something to debate after this wonderful news from Merck today. Being a mouse, from the BMS labs side of things has some advantages, mainly price tag, wow that is big bucks if you don't have coverage. My first thought about price, was will they charge by the Kilo and if so I am sure glad I am on the trial, otherwise I would need to go on a diet ASAP.  Here is something to think about, if the BMS trial of Ipi combined with Nivolumab get approved in the near future will insurance companies cover it ?  The trial that I am on has 4 doses of Ipi over 12 weeks and Nivolumab every two weeks for 2 years, I wonder what that price tag would look like?  My understanding is the big target for BMS is lung cancer approval with the combination. My stats might be off a little but I think there are around 200, 000 patients a year for lung cancer vs maybe 10,000 for melanoma. My last comment on the topic is ," boy I am sure glad these drugs are working." Stage 4 with brain and lung mets summer of 2013 and still here!!!!  Ed

Well Celeste, I like to think of myself more alone the lines of a mouse than a rat. It is nice to see that we can all find something to debate after this wonderful news from Merck today. Being a mouse, from the BMS labs side of things has some advantages, mainly price tag, wow that is big bucks if you don't have coverage. My first thought about price, was will they charge by the Kilo and if so I am sure glad I am on the trial, otherwise I would need to go on a diet ASAP.  Here is something to think about, if the BMS trial of Ipi combined with Nivolumab get approved in the near future will insurance companies cover it ?  The trial that I am on has 4 doses of Ipi over 12 weeks and Nivolumab every two weeks for 2 years, I wonder what that price tag would look like?  My understanding is the big target for BMS is lung cancer approval with the combination. My stats might be off a little but I think there are around 200, 000 patients a year for lung cancer vs maybe 10,000 for melanoma. My last comment on the topic is ," boy I am sure glad these drugs are working." Stage 4 with brain and lung mets summer of 2013 and still here!!!!  Ed

You can be a mouse, Ed!!!  I always rather liked being a rattie in my nivo trial.  I figured we rats had tougher tails.  But, either way….all of us are made of pretty tough stuff!!!  This approval provides a wonderful opportunity for many.  I just worry about those who may, STILL, not have the option as soon as they need it.  Hopefully, even more options and opportunities will come.  BMS will be sending in their FDA request for Nivo as a melanoma treatment by Sept 30 and as a treatment for lung cancer by the end of the year…so they say.  And yes, you are right.  The ipi and nivo combo is still in process as is some nivo/BRAF combos and nivo with anti-KIR.  Hopefully even more good news will come very soon!!! c

You can be a mouse, Ed!!!  I always rather liked being a rattie in my nivo trial.  I figured we rats had tougher tails.  But, either way….all of us are made of pretty tough stuff!!!  This approval provides a wonderful opportunity for many.  I just worry about those who may, STILL, not have the option as soon as they need it.  Hopefully, even more options and opportunities will come.  BMS will be sending in their FDA request for Nivo as a melanoma treatment by Sept 30 and as a treatment for lung cancer by the end of the year…so they say.  And yes, you are right.  The ipi and nivo combo is still in process as is some nivo/BRAF combos and nivo with anti-KIR.  Hopefully even more good news will come very soon!!! c

You can be a mouse, Ed!!!  I always rather liked being a rattie in my nivo trial.  I figured we rats had tougher tails.  But, either way….all of us are made of pretty tough stuff!!!  This approval provides a wonderful opportunity for many.  I just worry about those who may, STILL, not have the option as soon as they need it.  Hopefully, even more options and opportunities will come.  BMS will be sending in their FDA request for Nivo as a melanoma treatment by Sept 30 and as a treatment for lung cancer by the end of the year…so they say.  And yes, you are right.  The ipi and nivo combo is still in process as is some nivo/BRAF combos and nivo with anti-KIR.  Hopefully even more good news will come very soon!!! c

Hi Joe

Im totally agree with you, and that issue was commented with my onc. Many times i have thought the same as you, i think the different response to anti pd1 after ipi is not for ipi itself, is just because thouse people have a low response to inmunotheraphy and even taking pembro as a front line, the result would be the same.

Juan

Hi Joe

Im totally agree with you, and that issue was commented with my onc. Many times i have thought the same as you, i think the different response to anti pd1 after ipi is not for ipi itself, is just because thouse people have a low response to inmunotheraphy and even taking pembro as a front line, the result would be the same.

Juan

Hi Joe

Im totally agree with you, and that issue was commented with my onc. Many times i have thought the same as you, i think the different response to anti pd1 after ipi is not for ipi itself, is just because thouse people have a low response to inmunotheraphy and even taking pembro as a front line, the result would be the same.

Juan

I've been wondering the same thing Joe.

I've been wondering the same thing Joe.

I've been wondering the same thing Joe.

Yes, Joe.  Many researchers are already deeply involved in the research related to the priming of the immune system and how to retrigger an immune response AGAIN when needed!!!  Charles Drake, MD, PhD from John Hopkins and many others have been working on this for some time.  This post includes a link to an amazing presentation he gave in Baltimore in Sept of 2013.  Luckily, smart guys like him are learning more everyday to the benefit of all of us.

http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/06/how-to-make-anti-pd1-work-better-with.html

Yours, Celeste

Yes, Joe.  Many researchers are already deeply involved in the research related to the priming of the immune system and how to retrigger an immune response AGAIN when needed!!!  Charles Drake, MD, PhD from John Hopkins and many others have been working on this for some time.  This post includes a link to an amazing presentation he gave in Baltimore in Sept of 2013.  Luckily, smart guys like him are learning more everyday to the benefit of all of us.

http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/06/how-to-make-anti-pd1-work-better-with.html

Yours, Celeste

Yes, Joe.  Many researchers are already deeply involved in the research related to the priming of the immune system and how to retrigger an immune response AGAIN when needed!!!  Charles Drake, MD, PhD from John Hopkins and many others have been working on this for some time.  This post includes a link to an amazing presentation he gave in Baltimore in Sept of 2013.  Luckily, smart guys like him are learning more everyday to the benefit of all of us.

http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/06/how-to-make-anti-pd1-work-better-with.html

Yours, Celeste

Sadly, the data is very clear that anti-PD1 products work much better in treatment naive patients.  Hopefully, studies that continue to demonstrate that, like those published this year at ASCO, will allow docs to pressure all companies involved….insurance and manufacturers…to gain approval and payment for use as they see fit BEFORE patients are forced to fail both ipi and BRAFi. 

Yet, at least it is a step forward toward needed treatment for some.  Thanks to all the ratties out there who made it happen!!!  Best – c