› Forums › General Melanoma Community › Merck’s anti PD-1 eligibility question
- This topic has 30 replies, 4 voices, and was last updated 11 years, 2 months ago by
kalisama.
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- September 6, 2014 at 3:36 pm
That is what the FDA approval seems to say. Also says if one tests BRAF+ then one must have also failed the Anti-BRAF treatments. One question is how it can be used under both the individual states and the Medicare off-label laws.
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- September 6, 2014 at 3:36 pm
That is what the FDA approval seems to say. Also says if one tests BRAF+ then one must have also failed the Anti-BRAF treatments. One question is how it can be used under both the individual states and the Medicare off-label laws.
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- September 6, 2014 at 3:36 pm
That is what the FDA approval seems to say. Also says if one tests BRAF+ then one must have also failed the Anti-BRAF treatments. One question is how it can be used under both the individual states and the Medicare off-label laws.
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- September 6, 2014 at 4:01 pm
Correct, conditions of the approval require that patients must have tried and experienced disease progression following treatment with Yervoy (ipilimumab) and, for patients who have the BRAF mutation (“BRAF positive”), also tried and experienced disease progression following treatment with at least one of the several BRAF or MEK inhibitors, including Zelboraf (vemurafenib), Tafinlar (dabrafenib), or Mekinist (trametinib). Merck’s press release states it as follows:"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."The additional implications are that eligibility requires at least two doses of Yervoy and that a patient must experience disease progression within six months of finishing the course of Yervoy. It's not clear what that means for (1) someone who has side effects requiring them to discontinue Yervoy after a single dose, or (2) someone who has a good response or at least stable disease for six months following Yervoy and then has disease progression after six months. I just saw Jerry’s response above and as he mentioned, I imagine these circumstances and others will then involve off-label use of pembrolizumab.Joe -
- September 6, 2014 at 4:01 pm
Correct, conditions of the approval require that patients must have tried and experienced disease progression following treatment with Yervoy (ipilimumab) and, for patients who have the BRAF mutation (“BRAF positive”), also tried and experienced disease progression following treatment with at least one of the several BRAF or MEK inhibitors, including Zelboraf (vemurafenib), Tafinlar (dabrafenib), or Mekinist (trametinib). Merck’s press release states it as follows:"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."The additional implications are that eligibility requires at least two doses of Yervoy and that a patient must experience disease progression within six months of finishing the course of Yervoy. It's not clear what that means for (1) someone who has side effects requiring them to discontinue Yervoy after a single dose, or (2) someone who has a good response or at least stable disease for six months following Yervoy and then has disease progression after six months. I just saw Jerry’s response above and as he mentioned, I imagine these circumstances and others will then involve off-label use of pembrolizumab.Joe -
- September 6, 2014 at 4:01 pm
Correct, conditions of the approval require that patients must have tried and experienced disease progression following treatment with Yervoy (ipilimumab) and, for patients who have the BRAF mutation (“BRAF positive”), also tried and experienced disease progression following treatment with at least one of the several BRAF or MEK inhibitors, including Zelboraf (vemurafenib), Tafinlar (dabrafenib), or Mekinist (trametinib). Merck’s press release states it as follows:"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."The additional implications are that eligibility requires at least two doses of Yervoy and that a patient must experience disease progression within six months of finishing the course of Yervoy. It's not clear what that means for (1) someone who has side effects requiring them to discontinue Yervoy after a single dose, or (2) someone who has a good response or at least stable disease for six months following Yervoy and then has disease progression after six months. I just saw Jerry’s response above and as he mentioned, I imagine these circumstances and others will then involve off-label use of pembrolizumab.Joe-
- September 7, 2014 at 2:12 pm
Thank you for clarifying, this is so disapointing. I have had progression on Zelb. and Taf/Mek combo. Starting Ipi for 6+ months simply to be eligible, when I have already decided not to go that route for several reasons, is beyond frustrating.
If you have a moment, could you explain to me what off-label use is?
Thank you again for your time and clarification,
kali -
- September 7, 2014 at 2:12 pm
Thank you for clarifying, this is so disapointing. I have had progression on Zelb. and Taf/Mek combo. Starting Ipi for 6+ months simply to be eligible, when I have already decided not to go that route for several reasons, is beyond frustrating.
If you have a moment, could you explain to me what off-label use is?
Thank you again for your time and clarification,
kali -
- September 7, 2014 at 2:12 pm
Thank you for clarifying, this is so disapointing. I have had progression on Zelb. and Taf/Mek combo. Starting Ipi for 6+ months simply to be eligible, when I have already decided not to go that route for several reasons, is beyond frustrating.
If you have a moment, could you explain to me what off-label use is?
Thank you again for your time and clarification,
kali -
- September 7, 2014 at 6:38 pm
Kali,
I don't think they aren't saying that you necessarily have to stay on ipi for 6 months (a standard four dose course of ipi only lasts 9 weeks from first dose until last dose). What I think it means is two things: first, obviously, if you have a response to ipi, you're not eligible for pembro. Second, if you have a response, or even stable disease, with ipi that lasts longer than 6 months, and then have disease progression, then you wouldn't be eligible for pembro. Frankly, it's confusing and worth asking your doctor about. But it sounds like the implication is that in that situation, you need to have another course or ipi before being eligible for pembro.
My understanding is that one a medication is approved by the FDA, it can be prescribed for "off-label" use, in other words for situations outside for what it was approved, for example, other diseases or scenarios. The biggest challenge becomes whether it will be covered by insurance or not. Some companies may not cover any off-label use while others may have specific off-label situations they'll cover, and I imagine there's a documentation and approval process that doctors must follow to get a medication off-label for a patient.
Regards, Joe
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- September 7, 2014 at 6:38 pm
Kali,
I don't think they aren't saying that you necessarily have to stay on ipi for 6 months (a standard four dose course of ipi only lasts 9 weeks from first dose until last dose). What I think it means is two things: first, obviously, if you have a response to ipi, you're not eligible for pembro. Second, if you have a response, or even stable disease, with ipi that lasts longer than 6 months, and then have disease progression, then you wouldn't be eligible for pembro. Frankly, it's confusing and worth asking your doctor about. But it sounds like the implication is that in that situation, you need to have another course or ipi before being eligible for pembro.
My understanding is that one a medication is approved by the FDA, it can be prescribed for "off-label" use, in other words for situations outside for what it was approved, for example, other diseases or scenarios. The biggest challenge becomes whether it will be covered by insurance or not. Some companies may not cover any off-label use while others may have specific off-label situations they'll cover, and I imagine there's a documentation and approval process that doctors must follow to get a medication off-label for a patient.
Regards, Joe
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- September 7, 2014 at 6:38 pm
Kali,
I don't think they aren't saying that you necessarily have to stay on ipi for 6 months (a standard four dose course of ipi only lasts 9 weeks from first dose until last dose). What I think it means is two things: first, obviously, if you have a response to ipi, you're not eligible for pembro. Second, if you have a response, or even stable disease, with ipi that lasts longer than 6 months, and then have disease progression, then you wouldn't be eligible for pembro. Frankly, it's confusing and worth asking your doctor about. But it sounds like the implication is that in that situation, you need to have another course or ipi before being eligible for pembro.
My understanding is that one a medication is approved by the FDA, it can be prescribed for "off-label" use, in other words for situations outside for what it was approved, for example, other diseases or scenarios. The biggest challenge becomes whether it will be covered by insurance or not. Some companies may not cover any off-label use while others may have specific off-label situations they'll cover, and I imagine there's a documentation and approval process that doctors must follow to get a medication off-label for a patient.
Regards, Joe
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- September 11, 2014 at 1:42 pm
his is not my understanding. The quote above is from the trial of pembro, not the prescribing information. My oncologist says that as long as you tried Yervoy (and BRAF drugs if applicable) and it either caused side effects and you had to stop (my case after one dose) or you progress then you can move on to pembro.
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- September 11, 2014 at 2:34 pm
Oh my goodness, thank you for the clarification! I was just about to reply with the full link and cite the paragraph and sentence, but I just reread the section and it appears to be as you said, the criteria that were used for the KEYNOTE-001 trial.
From:
"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."
Thanks again and my apologies to all for the confusion!
Best, Joe
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- September 11, 2014 at 2:34 pm
Oh my goodness, thank you for the clarification! I was just about to reply with the full link and cite the paragraph and sentence, but I just reread the section and it appears to be as you said, the criteria that were used for the KEYNOTE-001 trial.
From:
"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."
Thanks again and my apologies to all for the confusion!
Best, Joe
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- September 11, 2014 at 2:34 pm
Oh my goodness, thank you for the clarification! I was just about to reply with the full link and cite the paragraph and sentence, but I just reread the section and it appears to be as you said, the criteria that were used for the KEYNOTE-001 trial.
From:
"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."
Thanks again and my apologies to all for the confusion!
Best, Joe
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- September 11, 2014 at 1:42 pm
his is not my understanding. The quote above is from the trial of pembro, not the prescribing information. My oncologist says that as long as you tried Yervoy (and BRAF drugs if applicable) and it either caused side effects and you had to stop (my case after one dose) or you progress then you can move on to pembro.
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- September 11, 2014 at 1:42 pm
his is not my understanding. The quote above is from the trial of pembro, not the prescribing information. My oncologist says that as long as you tried Yervoy (and BRAF drugs if applicable) and it either caused side effects and you had to stop (my case after one dose) or you progress then you can move on to pembro.
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- September 8, 2014 at 12:49 am
Basically Off label is the usage of a medicine that is not on the approved list that the FDA approved the medicine for. I have read that aboout 40% of USW drugs approved by the FDA for specific are used for other uses. Medicare and about 1/2 of the 50 states have developed laws related to "other uses (off-label usage). Most state laws are similiar, but not exactly like the Medicare laws. Look up your state AND "off-label" AND Cancer to get your states off-label laws that relate specifically yo cancer.
http://jop.ascopubs.org/content/5/1/18.full
Recent Developments in Medicare Coverage of Off-Label Cancer Therapies
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- September 8, 2014 at 12:53 am
P.S. I have been on an off-label targeted Chemo drug (Gleevec) for over five years now that has held my c-kit mucosal melanoma stable since immediately after starting it.
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- September 8, 2014 at 12:53 am
P.S. I have been on an off-label targeted Chemo drug (Gleevec) for over five years now that has held my c-kit mucosal melanoma stable since immediately after starting it.
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- September 8, 2014 at 12:53 am
P.S. I have been on an off-label targeted Chemo drug (Gleevec) for over five years now that has held my c-kit mucosal melanoma stable since immediately after starting it.
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- September 8, 2014 at 12:49 am
Basically Off label is the usage of a medicine that is not on the approved list that the FDA approved the medicine for. I have read that aboout 40% of USW drugs approved by the FDA for specific are used for other uses. Medicare and about 1/2 of the 50 states have developed laws related to "other uses (off-label usage). Most state laws are similiar, but not exactly like the Medicare laws. Look up your state AND "off-label" AND Cancer to get your states off-label laws that relate specifically yo cancer.
http://jop.ascopubs.org/content/5/1/18.full
Recent Developments in Medicare Coverage of Off-Label Cancer Therapies
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- September 8, 2014 at 12:49 am
Basically Off label is the usage of a medicine that is not on the approved list that the FDA approved the medicine for. I have read that aboout 40% of USW drugs approved by the FDA for specific are used for other uses. Medicare and about 1/2 of the 50 states have developed laws related to "other uses (off-label usage). Most state laws are similiar, but not exactly like the Medicare laws. Look up your state AND "off-label" AND Cancer to get your states off-label laws that relate specifically yo cancer.
http://jop.ascopubs.org/content/5/1/18.full
Recent Developments in Medicare Coverage of Off-Label Cancer Therapies
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