pembrolizumab

Brian, I've heard similar rumors, too, but haven't seen anything substantive about it. I doubt there will be head-to-head studies, so perhaps the best we'll be able do is compare results from large studies, which still leaves room for confusion depending on how the studies are constructed and patients are accrued. With ipi already available, BMS has an especially interesting "hand of cards" and much will depend on how they decide to approach it. Some studies seem to show similar results for BMS and Merck anti-PD-1 (are we calling the nivo and pembro now?). But the ipi/nivo combination seems to improve on either as a monotherapy. It's wonderful that these options are fast becoming available, but confusing for patients.

I've also noticed a greater emphasis on 1- and 2-year overall survival (OS) rates instead of response rates, OR, CR, PR, etc., out of ASCO this year. Not saying that it's good or bad, just an observation that may just be something I'm perceiving. It is a recognition that one doesn't have to be considered a complete responder to reach any survival milestones, and with combination therapies, including combining systemic therapies with more "tactical" treatments of surgery and radiation, someone can reach NED without being a complete responder to any one therapy. Again, just thinking out loud…

I'm curious, too, if anyone has any comments on BMS' vs. Merck's anti-PD-1?  Whether that's data, comments from their medical oncologist, or even just personal opinion? The impression I have (perhaps falsely) is that institutions are aligning with and offering one or the other, but not both. Is that correct or are there hospitals actively participating in trials for both?

When I mentioned to my long distance doc that pembro at 10mg/kg every 2 weeks got a 52% response rate but that same dose every 3 weeks got 27% response rate he basically said he could get 100 different people and the responses would be different. Also the 2mg/kg every 3 weeks got 25% which is what I'm getting and what the FDA is looking at. That still doesn't make sense to me what he said but I think his point was they have a medicine that works they just don't know yet why it works in some and not in others. There is also some data to suggest if it is working for you and you have I believe it's pdl on your tumors then it works better.

My local doc does BMS but I was never allowed to take it so I don't know much about it except that doc always said everyone is different. He can give 1 medicine to a person and it works and another it doesn't. 1 person can have tons of side affects and another doesn't. Like I took zelboraf which did not work and I had over 24 side affects. But I took the taf/mek combo got a partial response and few side affects. Other's of his patients have had lots of side affects with the taf/mek combo so he switched them to zelboraf and they had few side affects.

That about the jist of the comments I've had from my 2 doctors.

Also my local doc has applied for the Merck EAP although they never did Merck pd1. They are just waiting for Merck to get it to them. So yeah most probably picked one or the other during the trials probably so they didn't have to deal with double the paper work but now that they are both getting close to FDA approval they are getting on board with both.

When I mentioned to my long distance doc that pembro at 10mg/kg every 2 weeks got a 52% response rate but that same dose every 3 weeks got 27% response rate he basically said he could get 100 different people and the responses would be different. Also the 2mg/kg every 3 weeks got 25% which is what I'm getting and what the FDA is looking at. That still doesn't make sense to me what he said but I think his point was they have a medicine that works they just don't know yet why it works in some and not in others. There is also some data to suggest if it is working for you and you have I believe it's pdl on your tumors then it works better.

My local doc does BMS but I was never allowed to take it so I don't know much about it except that doc always said everyone is different. He can give 1 medicine to a person and it works and another it doesn't. 1 person can have tons of side affects and another doesn't. Like I took zelboraf which did not work and I had over 24 side affects. But I took the taf/mek combo got a partial response and few side affects. Other's of his patients have had lots of side affects with the taf/mek combo so he switched them to zelboraf and they had few side affects.

That about the jist of the comments I've had from my 2 doctors.

Also my local doc has applied for the Merck EAP although they never did Merck pd1. They are just waiting for Merck to get it to them. So yeah most probably picked one or the other during the trials probably so they didn't have to deal with double the paper work but now that they are both getting close to FDA approval they are getting on board with both.

When I mentioned to my long distance doc that pembro at 10mg/kg every 2 weeks got a 52% response rate but that same dose every 3 weeks got 27% response rate he basically said he could get 100 different people and the responses would be different. Also the 2mg/kg every 3 weeks got 25% which is what I'm getting and what the FDA is looking at. That still doesn't make sense to me what he said but I think his point was they have a medicine that works they just don't know yet why it works in some and not in others. There is also some data to suggest if it is working for you and you have I believe it's pdl on your tumors then it works better.

My local doc does BMS but I was never allowed to take it so I don't know much about it except that doc always said everyone is different. He can give 1 medicine to a person and it works and another it doesn't. 1 person can have tons of side affects and another doesn't. Like I took zelboraf which did not work and I had over 24 side affects. But I took the taf/mek combo got a partial response and few side affects. Other's of his patients have had lots of side affects with the taf/mek combo so he switched them to zelboraf and they had few side affects.

That about the jist of the comments I've had from my 2 doctors.

Also my local doc has applied for the Merck EAP although they never did Merck pd1. They are just waiting for Merck to get it to them. So yeah most probably picked one or the other during the trials probably so they didn't have to deal with double the paper work but now that they are both getting close to FDA approval they are getting on board with both.

Brian, I've heard similar rumors, too, but haven't seen anything substantive about it. I doubt there will be head-to-head studies, so perhaps the best we'll be able do is compare results from large studies, which still leaves room for confusion depending on how the studies are constructed and patients are accrued. With ipi already available, BMS has an especially interesting "hand of cards" and much will depend on how they decide to approach it. Some studies seem to show similar results for BMS and Merck anti-PD-1 (are we calling the nivo and pembro now?). But the ipi/nivo combination seems to improve on either as a monotherapy. It's wonderful that these options are fast becoming available, but confusing for patients.

I've also noticed a greater emphasis on 1- and 2-year overall survival (OS) rates instead of response rates, OR, CR, PR, etc., out of ASCO this year. Not saying that it's good or bad, just an observation that may just be something I'm perceiving. It is a recognition that one doesn't have to be considered a complete responder to reach any survival milestones, and with combination therapies, including combining systemic therapies with more "tactical" treatments of surgery and radiation, someone can reach NED without being a complete responder to any one therapy. Again, just thinking out loud…

I'm curious, too, if anyone has any comments on BMS' vs. Merck's anti-PD-1?  Whether that's data, comments from their medical oncologist, or even just personal opinion? The impression I have (perhaps falsely) is that institutions are aligning with and offering one or the other, but not both. Is that correct or are there hospitals actively participating in trials for both?

Brian, I've heard similar rumors, too, but haven't seen anything substantive about it. I doubt there will be head-to-head studies, so perhaps the best we'll be able do is compare results from large studies, which still leaves room for confusion depending on how the studies are constructed and patients are accrued. With ipi already available, BMS has an especially interesting "hand of cards" and much will depend on how they decide to approach it. Some studies seem to show similar results for BMS and Merck anti-PD-1 (are we calling the nivo and pembro now?). But the ipi/nivo combination seems to improve on either as a monotherapy. It's wonderful that these options are fast becoming available, but confusing for patients.

I've also noticed a greater emphasis on 1- and 2-year overall survival (OS) rates instead of response rates, OR, CR, PR, etc., out of ASCO this year. Not saying that it's good or bad, just an observation that may just be something I'm perceiving. It is a recognition that one doesn't have to be considered a complete responder to reach any survival milestones, and with combination therapies, including combining systemic therapies with more "tactical" treatments of surgery and radiation, someone can reach NED without being a complete responder to any one therapy. Again, just thinking out loud…

I'm curious, too, if anyone has any comments on BMS' vs. Merck's anti-PD-1?  Whether that's data, comments from their medical oncologist, or even just personal opinion? The impression I have (perhaps falsely) is that institutions are aligning with and offering one or the other, but not both. Is that correct or are there hospitals actively participating in trials for both?

I'm getting ready to start (fingers crossed that I'm not disqualified after scans on Friday) the Merk EAP. At my appointment last week I mentioned that BMS was opening an EAP of their own and asked if he thought one was better than the other. He told me he wasnt allowed to say, but that so far the side effect profiles seem to be similar. Then he said: "Really we just don't know- they haven't been around long enough to make any meaningful objective comparisons." Fair enough, I suppose. I did check at 2 other regional research centers (that are more convenient than the one I'm going to, one of which is Sloan Kettering) and was surprised to see that neither was offering either of the EAPs. I did notice, however, that Sloan Kettering's listing of trials heavily favored BMS drugs, and I do wonder if they were waiting for the BMS EAP, but I was still surprised that they weren't offering the Merk. Oh well. Merk is what is available to me right now so Merk is what I'll get and I'll be happy I get anything at all. I just hope it works.

Interesting side note- when we discussed the EAP and I heard that the protocol is a dose every 3 weeks for 2 years (assuming all goes well, etc) I was a bit surprised. I asked if that was the protocol they were seeking FDA approval for or if they were applying with a shorter course, like with Ipi. The response was that the FDA approved protocol for Ipi is actually 4 initial doses then a booster every 12 weeks, it's just that insurance refuses to pay for the boosters so no one ever gets more than the initial 4 doses. Merk is applying for every 3 weeks for 2 years as their protocol for PD-1- I wonder what the insurance companies will pay for this time…

Thanks for bringing up the issue of what the FDA approved regimen for PD1 might look like. The uncertainty around it, given the prior example of IPI, is one reason I feel good about being in a trial, for the opportunity to get a "full" 96 week regimen of PD1, if all goes well.

For IPI I received the FDA/insurance company approved 4 dose cycle in 2011. And I *didn't* know, or at least don't remember, that there is an FDA approved booster maintenance doseage as well — even if it is a moot issue with insurance.

– Kyle

Thanks for bringing up the issue of what the FDA approved regimen for PD1 might look like. The uncertainty around it, given the prior example of IPI, is one reason I feel good about being in a trial, for the opportunity to get a "full" 96 week regimen of PD1, if all goes well.

For IPI I received the FDA/insurance company approved 4 dose cycle in 2011. And I *didn't* know, or at least don't remember, that there is an FDA approved booster maintenance doseage as well — even if it is a moot issue with insurance.

– Kyle

Thanks for bringing up the issue of what the FDA approved regimen for PD1 might look like. The uncertainty around it, given the prior example of IPI, is one reason I feel good about being in a trial, for the opportunity to get a "full" 96 week regimen of PD1, if all goes well.

For IPI I received the FDA/insurance company approved 4 dose cycle in 2011. And I *didn't* know, or at least don't remember, that there is an FDA approved booster maintenance doseage as well — even if it is a moot issue with insurance.

– Kyle

I'm getting ready to start (fingers crossed that I'm not disqualified after scans on Friday) the Merk EAP. At my appointment last week I mentioned that BMS was opening an EAP of their own and asked if he thought one was better than the other. He told me he wasnt allowed to say, but that so far the side effect profiles seem to be similar. Then he said: "Really we just don't know- they haven't been around long enough to make any meaningful objective comparisons." Fair enough, I suppose. I did check at 2 other regional research centers (that are more convenient than the one I'm going to, one of which is Sloan Kettering) and was surprised to see that neither was offering either of the EAPs. I did notice, however, that Sloan Kettering's listing of trials heavily favored BMS drugs, and I do wonder if they were waiting for the BMS EAP, but I was still surprised that they weren't offering the Merk. Oh well. Merk is what is available to me right now so Merk is what I'll get and I'll be happy I get anything at all. I just hope it works.

Interesting side note- when we discussed the EAP and I heard that the protocol is a dose every 3 weeks for 2 years (assuming all goes well, etc) I was a bit surprised. I asked if that was the protocol they were seeking FDA approval for or if they were applying with a shorter course, like with Ipi. The response was that the FDA approved protocol for Ipi is actually 4 initial doses then a booster every 12 weeks, it's just that insurance refuses to pay for the boosters so no one ever gets more than the initial 4 doses. Merk is applying for every 3 weeks for 2 years as their protocol for PD-1- I wonder what the insurance companies will pay for this time…

I'm getting ready to start (fingers crossed that I'm not disqualified after scans on Friday) the Merk EAP. At my appointment last week I mentioned that BMS was opening an EAP of their own and asked if he thought one was better than the other. He told me he wasnt allowed to say, but that so far the side effect profiles seem to be similar. Then he said: "Really we just don't know- they haven't been around long enough to make any meaningful objective comparisons." Fair enough, I suppose. I did check at 2 other regional research centers (that are more convenient than the one I'm going to, one of which is Sloan Kettering) and was surprised to see that neither was offering either of the EAPs. I did notice, however, that Sloan Kettering's listing of trials heavily favored BMS drugs, and I do wonder if they were waiting for the BMS EAP, but I was still surprised that they weren't offering the Merk. Oh well. Merk is what is available to me right now so Merk is what I'll get and I'll be happy I get anything at all. I just hope it works.

Interesting side note- when we discussed the EAP and I heard that the protocol is a dose every 3 weeks for 2 years (assuming all goes well, etc) I was a bit surprised. I asked if that was the protocol they were seeking FDA approval for or if they were applying with a shorter course, like with Ipi. The response was that the FDA approved protocol for Ipi is actually 4 initial doses then a booster every 12 weeks, it's just that insurance refuses to pay for the boosters so no one ever gets more than the initial 4 doses. Merk is applying for every 3 weeks for 2 years as their protocol for PD-1- I wonder what the insurance companies will pay for this time…