Keytruda Off Label

I just started a monotherapy of Keytruda (Off Label) 1 week ago this past Thursday.  I saw on another post that Nano happened to start Keytruda on the same day (although it appears not to a monotherapy).  Does anyone else have any experience with Keytruda?  

«1

Comments

  • NanoSecond
    NanoSecond Member Posts: 653
    Monotherapy

    While it is true that I still take Avastin along with Keytruda (which I started on a little less than 2 weeks ago).  However, the Avastin is to prevent fluid build-up - it is not clear, what, if any, synergism there might be with Keytruda - although I am aware there is a clinical trial that combines them in the same manner I am.

    If I do not respond to Keytruda alone then my oncologist plans to add Ipilumumab (Yervoy - an anti-CTLA4) to the mix.  This will almost double the chances that I will show a response - but it likewise will more than double the risk of a severe auto-immune response (not good).

  • todd121
    todd121 Member Posts: 1,448 Member

    Monotherapy

    While it is true that I still take Avastin along with Keytruda (which I started on a little less than 2 weeks ago).  However, the Avastin is to prevent fluid build-up - it is not clear, what, if any, synergism there might be with Keytruda - although I am aware there is a clinical trial that combines them in the same manner I am.

    If I do not respond to Keytruda alone then my oncologist plans to add Ipilumumab (Yervoy - an anti-CTLA4) to the mix.  This will almost double the chances that I will show a response - but it likewise will more than double the risk of a severe auto-immune response (not good).

    Good Luck!

    Neil,

    Best of luck to you on this drug. I'm pulling for you. Glad that you've been pretty stable on Afinitor.

    Did you experience any side effects on Afinitor? How did you feel? How long have you been taking it now?

    Todd

  • NanoSecond
    NanoSecond Member Posts: 653
    todd121 said:

    Good Luck!

    Neil,

    Best of luck to you on this drug. I'm pulling for you. Glad that you've been pretty stable on Afinitor.

    Did you experience any side effects on Afinitor? How did you feel? How long have you been taking it now?

    Todd

    Afinitor

    Many thanks Todd. I had been more than stable on Afinitor.  I was considered an "exceptional responder" because after 8 weeks all of my tumors has shrunk - some by as much as 50%.  Only 3% of patients get that kind of response.

    The only side effect I had on Afinitor was annoying Acne - mostly on my scalp and chest.  I felt great on the drug and have regretted having to stop it.  I started it on June 28th and stopped taking it on November 9th - 4 days before I got my first infusion of Keytruda.

  • KeepCalmAnd
    KeepCalmAnd Member Posts: 8

    Monotherapy

    While it is true that I still take Avastin along with Keytruda (which I started on a little less than 2 weeks ago).  However, the Avastin is to prevent fluid build-up - it is not clear, what, if any, synergism there might be with Keytruda - although I am aware there is a clinical trial that combines them in the same manner I am.

    If I do not respond to Keytruda alone then my oncologist plans to add Ipilumumab (Yervoy - an anti-CTLA4) to the mix.  This will almost double the chances that I will show a response - but it likewise will more than double the risk of a severe auto-immune response (not good).

    Side Effects

    Nano - how have your side effects been on Keytruda?  Anything noticeable? 

  • NanoSecond
    NanoSecond Member Posts: 653

    Side Effects

    Nano - how have your side effects been on Keytruda?  Anything noticeable? 

    Side effects

    So far only high fatigue for about 5 days following the infusion.  Some low grade fevers that came and went as well.

  • vinnyc
    vinnyc Member Posts: 19

    Afinitor

    Many thanks Todd. I had been more than stable on Afinitor.  I was considered an "exceptional responder" because after 8 weeks all of my tumors has shrunk - some by as much as 50%.  Only 3% of patients get that kind of response.

    The only side effect I had on Afinitor was annoying Acne - mostly on my scalp and chest.  I felt great on the drug and have regretted having to stop it.  I started it on June 28th and stopped taking it on November 9th - 4 days before I got my first infusion of Keytruda.

    Affinitor

    My massive neck lymph node started to shrink after a week on Affinitor. 3 month scan all lesions shrunk. It wasn't clear why you had to stop affinitor after just over 4 months.

  • NanoSecond
    NanoSecond Member Posts: 653
    vinnyc said:

    Affinitor

    My massive neck lymph node started to shrink after a week on Affinitor. 3 month scan all lesions shrunk. It wasn't clear why you had to stop affinitor after just over 4 months.

    Why I stopped Afinitor

    Even though my CT-scan on October 30th looked good on paper - with no progression and no new mets - my oncologist was concerned about 4 blood test results.  Three of them concerned my liver enzymes.  They were slowly rising.  The fourth parameter, my LDH (Lactate Dehydrogenase) level was also increasing.  This was a bad sign because my LDH has perfectly tracked the progression and regression of my mets.  The bottom line is that my oncologist felt that these results meant that Afinitor was failing or about to fail.  He did not want to wait to find out which because Keytruda can take up to 3 months before it "works".  So we immediately took steps to get it, figuring we would have to fight with my insurance company to get coverage.  However, there was no fight.  They approved coverage in less than one week.

    I have now been off of Afinitor for over 3 weeks.  My next Keytruda infusion will be this Thursday.  Of course we will also be looking closely at those 4 blood tests.  Last week, 2 of the 3 liver enzymes had reversed and were heading back to normal.  Of more significance, my LDH level had also reversed and was heading back down again.  I am hoping this trend will be shown to be continuing on Thursday.  We'll see.

  • vinnyc
    vinnyc Member Posts: 19

    Why I stopped Afinitor

    Even though my CT-scan on October 30th looked good on paper - with no progression and no new mets - my oncologist was concerned about 4 blood test results.  Three of them concerned my liver enzymes.  They were slowly rising.  The fourth parameter, my LDH (Lactate Dehydrogenase) level was also increasing.  This was a bad sign because my LDH has perfectly tracked the progression and regression of my mets.  The bottom line is that my oncologist felt that these results meant that Afinitor was failing or about to fail.  He did not want to wait to find out which because Keytruda can take up to 3 months before it "works".  So we immediately took steps to get it, figuring we would have to fight with my insurance company to get coverage.  However, there was no fight.  They approved coverage in less than one week.

    I have now been off of Afinitor for over 3 weeks.  My next Keytruda infusion will be this Thursday.  Of course we will also be looking closely at those 4 blood tests.  Last week, 2 of the 3 liver enzymes had reversed and were heading back to normal.  Of more significance, my LDH level had also reversed and was heading back down again.  I am hoping this trend will be shown to be continuing on Thursday.  We'll see.

    Off label

    Hi NanoSecond   I may be in a similar situation, but I'll ride affinitor for as long as I can, as long as my scans are ok. I'm in San Francisco @ UCSF.

    My Dr. thinks a dramatic response can equal a long response. I guess you could go back to Affinitor in the future, if needed.

    Liver enzymes could be from Affinitor and dying cancer cells could raise LDH.

    I was dying and had a few weeks left, I started Affinitor and after a week I could feel my massive neck masses starting to shrink,

    3 month scan showed multiple liver, lung, abdominal and the mediastinal masses squeezing my heart all shrunk.

    My next scan will be in January 2015. We are almost synced.

    Ofcourse I have to think about the next option.

    I'm so worried about using retirement money my wife will need later, just to buy PD-1 for me , with no guarantee.

    You have renal cell and your insurance approved. You're so lucky. I have Healthnet/Senority Plus, a Medicare plan.

    What is your health plan? Are there any special pre-authorization codes or techniques?

    I know my doctor is already treating renal cell patients out-of-pocket with PD-1. I guess the patients did not even attempt to get it

    authorized or it was denied.  Good luck, I hope you have good results with your PD1 infusion. Vinny

     

     

  • NanoSecond
    NanoSecond Member Posts: 653
    vinnyc said:

    Off label

    Hi NanoSecond   I may be in a similar situation, but I'll ride affinitor for as long as I can, as long as my scans are ok. I'm in San Francisco @ UCSF.

    My Dr. thinks a dramatic response can equal a long response. I guess you could go back to Affinitor in the future, if needed.

    Liver enzymes could be from Affinitor and dying cancer cells could raise LDH.

    I was dying and had a few weeks left, I started Affinitor and after a week I could feel my massive neck masses starting to shrink,

    3 month scan showed multiple liver, lung, abdominal and the mediastinal masses squeezing my heart all shrunk.

    My next scan will be in January 2015. We are almost synced.

    Ofcourse I have to think about the next option.

    I'm so worried about using retirement money my wife will need later, just to buy PD-1 for me , with no guarantee.

    You have renal cell and your insurance approved. You're so lucky. I have Healthnet/Senority Plus, a Medicare plan.

    What is your health plan? Are there any special pre-authorization codes or techniques?

    I know my doctor is already treating renal cell patients out-of-pocket with PD-1. I guess the patients did not even attempt to get it

    authorized or it was denied.  Good luck, I hope you have good results with your PD1 infusion. Vinny

     

     

    Off-label

    Hi Vinny.  Yes, you are correct, the elevated liver enzymes could have been due to Afinitor and the LDH could have been due to reasons other than Afinitor failing.  The point was we did not want to wait to find out if that was the case.  And yes, I can still go back to Afinitor at a later date as it did not "officially" fail me.

    Like you I was only weeks away from death when I started on Afinitor. And it worked almost immediately for me as well.  However, my LDH soon started to drop as well.  That is why when it starting going back up (while still on Afinitor) my oncologist got very concerned.

    My insurance is CareFirst/BlueCross/BlueShield in Maryland.  There are no special pre-authorization or techniques that I am aware of. They have been terrific.  They also never disputed covering the cost of Cabozantinib off-label.

    I was fully prepared to pay for Keytruda personally if necessary.  And then fight for as long as necessary to get coverage.  But that turned out to be not necessary in my case.

    Hang in there.  Nivolumab is now due to be FDA approved no later than March 2015.

     

  • vinnyc
    vinnyc Member Posts: 19

    Off-label

    Hi Vinny.  Yes, you are correct, the elevated liver enzymes could have been due to Afinitor and the LDH could have been due to reasons other than Afinitor failing.  The point was we did not want to wait to find out if that was the case.  And yes, I can still go back to Afinitor at a later date as it did not "officially" fail me.

    Like you I was only weeks away from death when I started on Afinitor. And it worked almost immediately for me as well.  However, my LDH soon started to drop as well.  That is why when it starting going back up (while still on Afinitor) my oncologist got very concerned.

    My insurance is CareFirst/BlueCross/BlueShield in Maryland.  There are no special pre-authorization or techniques that I am aware of. They have been terrific.  They also never disputed covering the cost of Cabozantinib off-label.

    I was fully prepared to pay for Keytruda personally if necessary.  And then fight for as long as necessary to get coverage.  But that turned out to be not necessary in my case.

    Hang in there.  Nivolumab is now due to be FDA approved no later than March 2015.

     

    keytruda off label

    Got it. Thanks

  • vinnyc
    vinnyc Member Posts: 19

    Off-label

    Hi Vinny.  Yes, you are correct, the elevated liver enzymes could have been due to Afinitor and the LDH could have been due to reasons other than Afinitor failing.  The point was we did not want to wait to find out if that was the case.  And yes, I can still go back to Afinitor at a later date as it did not "officially" fail me.

    Like you I was only weeks away from death when I started on Afinitor. And it worked almost immediately for me as well.  However, my LDH soon started to drop as well.  That is why when it starting going back up (while still on Afinitor) my oncologist got very concerned.

    My insurance is CareFirst/BlueCross/BlueShield in Maryland.  There are no special pre-authorization or techniques that I am aware of. They have been terrific.  They also never disputed covering the cost of Cabozantinib off-label.

    I was fully prepared to pay for Keytruda personally if necessary.  And then fight for as long as necessary to get coverage.  But that turned out to be not necessary in my case.

    Hang in there.  Nivolumab is now due to be FDA approved no later than March 2015.

     

    off label

    Forgot to ask, did your Dr. check your PDL1 expression? 

    Also a quick check online shows March 2015 date for Nivolumab FDA review for 

    melanoma, I did not see anything specific for Renal Cell Carcinoma. Where is the

    online link?

    Thanks Vinny

  • NanoSecond
    NanoSecond Member Posts: 653
    vinnyc said:

    off label

    Forgot to ask, did your Dr. check your PDL1 expression? 

    Also a quick check online shows March 2015 date for Nivolumab FDA review for 

    melanoma, I did not see anything specific for Renal Cell Carcinoma. Where is the

    online link?

    Thanks Vinny

    Questions

    1.  No, my doctor did not check for PDL1 expression.  It would be rather pointless.  You see some patients who do not express PDL1 have had significant responses while other patients with PDL1 expression have had none.  In other words, it is not a reliable marker.

    2. Nivolumab, like Keytruda, will first attempt to get approval for Melanoma, not renal cancer.  You will still have to apply to get Nivolumab off-label for mRCC.  Eventually they may or may not try to do the same for renal cancers.

    3.  There is no online link.  I got this information from several different doctors up at Johns Hopkins.  They conducted many of the initial clinical trials of Nivolumab.

  • sledhead
    sledhead Member Posts: 11

    Side effects

    So far only high fatigue for about 5 days following the infusion.  Some low grade fevers that came and went as well.

    off-label process

    How can one apply/obtain Keytruda off label for RCC? 

  • Srashedb
    Srashedb Member Posts: 482 Member
    vinnyc said:

    off label

    Forgot to ask, did your Dr. check your PDL1 expression? 

    Also a quick check online shows March 2015 date for Nivolumab FDA review for 

    melanoma, I did not see anything specific for Renal Cell Carcinoma. Where is the

    online link?

    Thanks Vinny

    UCSF

    Vinny, who do you see at UCSF? My husband is being treated there.

    Sarah

  • vinnyc
    vinnyc Member Posts: 19
    sledhead said:

    off-label process

    How can one apply/obtain Keytruda off label for RCC? 

    off label

    read the dec 3 reply conversation, it's there

  • vinnyc
    vinnyc Member Posts: 19
    Srashedb said:

    UCSF

    Vinny, who do you see at UCSF? My husband is being treated there.

    Sarah

    ucsf

    Started Dr. Minor CPMC, now Dr.Fong.

  • vinnyc
    vinnyc Member Posts: 19

    Questions

    1.  No, my doctor did not check for PDL1 expression.  It would be rather pointless.  You see some patients who do not express PDL1 have had significant responses while other patients with PDL1 expression have had none.  In other words, it is not a reliable marker.

    2. Nivolumab, like Keytruda, will first attempt to get approval for Melanoma, not renal cancer.  You will still have to apply to get Nivolumab off-label for mRCC.  Eventually they may or may not try to do the same for renal cancers.

    3.  There is no online link.  I got this information from several different doctors up at Johns Hopkins.  They conducted many of the initial clinical trials of Nivolumab.

    off label

    There is a statistical correlation in the trials, I just thought the insurance would want 

    to see that before authorizing,  since this not a trial and your getting it before FDA

    approval for Renal Cell. But this is not the case.

  • Srashedb
    Srashedb Member Posts: 482 Member
    vinnyc said:

    ucsf

    Started Dr. Minor CPMC, now Dr.Fong.

    UCSF?

    is Dr. Fong at UCSF or PMC?

     

  • vinnyc
    vinnyc Member Posts: 19
    Srashedb said:

    UCSF?

    is Dr. Fong at UCSF or PMC?

     

    Ucsf

     ucsfmedctr 

    dr sneed for radiation 

     

  • NanoSecond
    NanoSecond Member Posts: 653
    vinnyc said:

    off label

    There is a statistical correlation in the trials, I just thought the insurance would want 

    to see that before authorizing,  since this not a trial and your getting it before FDA

    approval for Renal Cell. But this is not the case.

    Correlation is not causation

    There is correlation with PDL1 expression in many cases but it is not always.  That is why oncologists are reluctant to use this as a biomarker.

    I have chromophobe - a rare cancer to begin with.  Rarer still is whenever chromophobe metastases.  Therefore there will never be a Phase III trial for metastatic chromophobe patients.  My insurance company agreed with this and waived that provision.