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Combo Nivo and Ipi Therapy questions
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Combo Nivo and Ipi Therapy questions

› Forums › General Melanoma Community › Combo Nivo and Ipi Therapy questions

  • Post
    • August 18, 2016 at 1:15 am
    slh4448
    Participant

      FDA Approves Opdivo and Yervoy Combination for Advanced Melanoma

       
      Thu, 2015-10-01

       

      Statement from Tim Turnham, Executive Director, Melanoma Research Foundation

       
      The Melanoma Research Foundation (MRF) applauds the FDA’s approval of the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for patients with previously untreated BRAF wild-type advanced melanoma. Today’s approval marks a turning point in melanoma treatment. For the first time patients will have access to a regimen that utilizes two critical findings—that the patient’s own immune system can be engaged in the fight against cancer, and that the right combination of two or more drugs can have a synergistic effect.
       
      Studies combining Opdivo and Yervoy, both developed by Bristol-Myers Squibb, show a much stronger response rate from people with previously untreated late-stage melanoma compared to Yervoy alone. Data from one study of the combination reported an objective response rate of 61% in previously untreated advanced melanoma patients, a number that would have been inconceivable just five years ago. 
       
      Both Opdivo and Yervoy are FDA-approved to treat advanced melanoma as monotherapies, or as independent treatments. Yervoy, an immunotherapy, was approved in 2011 after almost 13 years without a new treatment for advanced melanoma. Opdivo was approved by the FDA in late 2014. Both drugs are part of a class of drugs called “checkpoint inhibitors” which disable the body’s natural mechanisms for limiting the immune system. Immunotherapies have been shown to be effective in treating people with advanced melanoma. The combination of these two treatments result in an aggressive and innovative approach to fighting growing melanoma cells. 
       
      Melanoma researchers and scientists across the world agree the cure for melanoma is hiding in combination therapies. Key to this, however, is identifying the specific treatment for each individual patient that will result in a positive response. The combination of Yervoy and Opdivo brings the melanoma community one important step closer to finding the solution to this cancer

      SO HAS ANYONE ASKED ABOUT THIS AND/OR HAD DISCUSSIONS WITH YOUR DOCS ABOUT THIS??? I'm stage 3a. I saw my med onc today and we agreed to start on Ipi 3mg. Then I saw this…could I be on this combo?? I sent my onc an email just alittle while ago! Anyone have any feedback on this combo?? Thanks, Stacy

       

    Viewing 5 reply threads
    • Replies
        • August 18, 2016 at 1:51 am
        jennunicorn
        Participant

          The combo is only approved for stage 4.

          The only approved option (beside the old interferon) for stage 3 is Ipi, which you'll be doing.

          Hope Ipi goes smoothly for you.

          • August 18, 2016 at 1:51 am
          jennunicorn
          Participant

            The combo is only approved for stage 4.

            The only approved option (beside the old interferon) for stage 3 is Ipi, which you'll be doing.

            Hope Ipi goes smoothly for you.

            • August 18, 2016 at 1:51 am
            jennunicorn
            Participant

              The combo is only approved for stage 4.

              The only approved option (beside the old interferon) for stage 3 is Ipi, which you'll be doing.

              Hope Ipi goes smoothly for you.

                • August 18, 2016 at 12:28 pm
                slh4448
                Participant

                  Hey Jenn,

                  Thanks for the clarification. I wondered about that simply because I didn't see exactly what stage it would be approved for.

                  Yes, I am starting Yervoy 3mg infusions next Thursday. I appreciate your message about doing well on it! I too, hope it goes smoothy :-))

                  Stacy

                  • August 18, 2016 at 1:26 pm
                  ed williams
                  Participant

                    Stacy, there are also clinical trials out there offering the Pd-1 drugs Nivo or Pembro vs Ipi, for stage 3 folks. Best wishes!!!Ed

                    • August 18, 2016 at 4:52 pm
                    JohnA
                    Participant

                      Yes but don't forget the new data suggesting that ipi then nivo produces better outcomes than nivo then ipi.

                      i posted an article on this last week and Celeste has done a blog on it because, let's face it, she rocks.

                      • August 18, 2016 at 7:34 pm
                      ed williams
                      Participant

                        Hi John, I think it goes the other way, Nivo followed by Ipi for stage 4 folks is showing better result, which still is not as good as getting the combination of the two drugs at the same time. On the second comment I would have to agree with you that Celeste does rock and her blog is excellent. The only problem I have with her blog is I always get side tracked looking at all the sewing stuff!!! 

                        • August 18, 2016 at 7:34 pm
                        ed williams
                        Participant

                          Hi John, I think it goes the other way, Nivo followed by Ipi for stage 4 folks is showing better result, which still is not as good as getting the combination of the two drugs at the same time. On the second comment I would have to agree with you that Celeste does rock and her blog is excellent. The only problem I have with her blog is I always get side tracked looking at all the sewing stuff!!! 

                          • August 18, 2016 at 7:34 pm
                          ed williams
                          Participant

                            Hi John, I think it goes the other way, Nivo followed by Ipi for stage 4 folks is showing better result, which still is not as good as getting the combination of the two drugs at the same time. On the second comment I would have to agree with you that Celeste does rock and her blog is excellent. The only problem I have with her blog is I always get side tracked looking at all the sewing stuff!!! 

                            • August 18, 2016 at 10:04 pm
                            Bubbles
                            Participant

                              Hey John and my Edster!

                              Yes, Nivo THEN ipi yeilds a 41% response rate, while ipi followed by nivo provides an ORR of only 21%!!! It gets confusing, John….Ed and I have been swimming in these waters for a long time!!  But, you were right in trying to give a head's up.  Here's my rant on the subject from 2015:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/09/sequential-nivo-then-ipi-orr-of-41-ipi.html

                              Here's another report from ASCO 2016 (3rd report in this link):  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/05/asco-2016-three-anti-pd1-reports.html

                              Crazy stuff.  Had a great visit to Vancouver and Victoria recently, Ed.  And…if you'll send me your measurements….I'll make you a shirt that will delight your students!!! 

                              Keep up the good work, John.  We need all the help we can get from everybody here.  It's a pretty great team when you think about it!!

                              Love you both!  C

                              • August 18, 2016 at 10:04 pm
                              Bubbles
                              Participant

                                Hey John and my Edster!

                                Yes, Nivo THEN ipi yeilds a 41% response rate, while ipi followed by nivo provides an ORR of only 21%!!! It gets confusing, John….Ed and I have been swimming in these waters for a long time!!  But, you were right in trying to give a head's up.  Here's my rant on the subject from 2015:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/09/sequential-nivo-then-ipi-orr-of-41-ipi.html

                                Here's another report from ASCO 2016 (3rd report in this link):  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/05/asco-2016-three-anti-pd1-reports.html

                                Crazy stuff.  Had a great visit to Vancouver and Victoria recently, Ed.  And…if you'll send me your measurements….I'll make you a shirt that will delight your students!!! 

                                Keep up the good work, John.  We need all the help we can get from everybody here.  It's a pretty great team when you think about it!!

                                Love you both!  C

                                • August 18, 2016 at 10:04 pm
                                Bubbles
                                Participant

                                  Hey John and my Edster!

                                  Yes, Nivo THEN ipi yeilds a 41% response rate, while ipi followed by nivo provides an ORR of only 21%!!! It gets confusing, John….Ed and I have been swimming in these waters for a long time!!  But, you were right in trying to give a head's up.  Here's my rant on the subject from 2015:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/09/sequential-nivo-then-ipi-orr-of-41-ipi.html

                                  Here's another report from ASCO 2016 (3rd report in this link):  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/05/asco-2016-three-anti-pd1-reports.html

                                  Crazy stuff.  Had a great visit to Vancouver and Victoria recently, Ed.  And…if you'll send me your measurements….I'll make you a shirt that will delight your students!!! 

                                  Keep up the good work, John.  We need all the help we can get from everybody here.  It's a pretty great team when you think about it!!

                                  Love you both!  C

                                  • August 18, 2016 at 4:52 pm
                                  JohnA
                                  Participant

                                    Yes but don't forget the new data suggesting that ipi then nivo produces better outcomes than nivo then ipi.

                                    i posted an article on this last week and Celeste has done a blog on it because, let's face it, she rocks.

                                    • August 18, 2016 at 4:52 pm
                                    JohnA
                                    Participant

                                      Yes but don't forget the new data suggesting that ipi then nivo produces better outcomes than nivo then ipi.

                                      i posted an article on this last week and Celeste has done a blog on it because, let's face it, she rocks.

                                      • August 18, 2016 at 10:20 pm
                                      slh4448
                                      Participant

                                        Ed you're right. I did discuss that with my med onc and I don't qualify because I did not have the clnd which I believe is a criteria of getting into those types of trials. Do you or anyone else know any thing different perhaps because if so, I'd love to know about it. Thanks!

                                        Stacy

                                        • August 18, 2016 at 10:20 pm
                                        slh4448
                                        Participant

                                          Ed you're right. I did discuss that with my med onc and I don't qualify because I did not have the clnd which I believe is a criteria of getting into those types of trials. Do you or anyone else know any thing different perhaps because if so, I'd love to know about it. Thanks!

                                          Stacy

                                          • August 18, 2016 at 10:20 pm
                                          slh4448
                                          Participant

                                            Ed you're right. I did discuss that with my med onc and I don't qualify because I did not have the clnd which I believe is a criteria of getting into those types of trials. Do you or anyone else know any thing different perhaps because if so, I'd love to know about it. Thanks!

                                            Stacy

                                            • August 18, 2016 at 1:26 pm
                                            ed williams
                                            Participant

                                              Stacy, there are also clinical trials out there offering the Pd-1 drugs Nivo or Pembro vs Ipi, for stage 3 folks. Best wishes!!!Ed

                                              • August 18, 2016 at 1:26 pm
                                              ed williams
                                              Participant

                                                Stacy, there are also clinical trials out there offering the Pd-1 drugs Nivo or Pembro vs Ipi, for stage 3 folks. Best wishes!!!Ed

                                                • August 18, 2016 at 12:28 pm
                                                slh4448
                                                Participant

                                                  Hey Jenn,

                                                  Thanks for the clarification. I wondered about that simply because I didn't see exactly what stage it would be approved for.

                                                  Yes, I am starting Yervoy 3mg infusions next Thursday. I appreciate your message about doing well on it! I too, hope it goes smoothy :-))

                                                  Stacy

                                                  • August 18, 2016 at 12:28 pm
                                                  slh4448
                                                  Participant

                                                    Hey Jenn,

                                                    Thanks for the clarification. I wondered about that simply because I didn't see exactly what stage it would be approved for.

                                                    Yes, I am starting Yervoy 3mg infusions next Thursday. I appreciate your message about doing well on it! I too, hope it goes smoothy :-))

                                                    Stacy

                                                  • August 18, 2016 at 10:16 pm
                                                  slh4448
                                                  Participant

                                                    Thanks all for your comments. I actually asked my med onc who is going to start me on Vervoy 3mg next week if I could have the ipi/nivo combo and he said no because he is treating me adjuctantly with a single agent.

                                                    Now I know from reading about nivo that a stage 3 person can get this drug if they have a unresectable tumor/cancer. I had surgery and only one lymph node removed from the snlb, which was positive, but not doing the clnd. My thought is and another question that I will ask my med onc is why can't he write for the combo "off-label"? Docs use drugs all the time off-label. Just curious and maybe it is a hard no and that's the way it is, but won't hurt to ask, right?

                                                    Both drugs made by BMS so "maybe" easier to get off-label than two drugs from two different manufacturers??? I'm just thinking out loud here and certainly welcome any more comments fro you guys!!

                                                    Thanks,

                                                    Stacy

                                                    • August 18, 2016 at 10:16 pm
                                                    slh4448
                                                    Participant

                                                      Thanks all for your comments. I actually asked my med onc who is going to start me on Vervoy 3mg next week if I could have the ipi/nivo combo and he said no because he is treating me adjuctantly with a single agent.

                                                      Now I know from reading about nivo that a stage 3 person can get this drug if they have a unresectable tumor/cancer. I had surgery and only one lymph node removed from the snlb, which was positive, but not doing the clnd. My thought is and another question that I will ask my med onc is why can't he write for the combo "off-label"? Docs use drugs all the time off-label. Just curious and maybe it is a hard no and that's the way it is, but won't hurt to ask, right?

                                                      Both drugs made by BMS so "maybe" easier to get off-label than two drugs from two different manufacturers??? I'm just thinking out loud here and certainly welcome any more comments fro you guys!!

                                                      Thanks,

                                                      Stacy

                                                        • August 18, 2016 at 10:45 pm
                                                        jennunicorn
                                                        Participant

                                                          They are doing trials for Nivo and Pembro testing in the adjuvant (stage 3) setting but to qualify I believe you'd have to have had more than 1 positive node, besides the clnd as well. So, at some point probably not too far off, Nivo will be available in the adjuvant setting. I have not heard of anyone stage 3A getting Nivo off-label, pretty sure it will be a no from your onc, because there is just no data supporting Nivo for use with someone in your case right now, but of course it never hurts to ask.

                                                          • August 18, 2016 at 10:45 pm
                                                          jennunicorn
                                                          Participant

                                                            They are doing trials for Nivo and Pembro testing in the adjuvant (stage 3) setting but to qualify I believe you'd have to have had more than 1 positive node, besides the clnd as well. So, at some point probably not too far off, Nivo will be available in the adjuvant setting. I have not heard of anyone stage 3A getting Nivo off-label, pretty sure it will be a no from your onc, because there is just no data supporting Nivo for use with someone in your case right now, but of course it never hurts to ask.

                                                            • August 18, 2016 at 10:45 pm
                                                            jennunicorn
                                                            Participant

                                                              They are doing trials for Nivo and Pembro testing in the adjuvant (stage 3) setting but to qualify I believe you'd have to have had more than 1 positive node, besides the clnd as well. So, at some point probably not too far off, Nivo will be available in the adjuvant setting. I have not heard of anyone stage 3A getting Nivo off-label, pretty sure it will be a no from your onc, because there is just no data supporting Nivo for use with someone in your case right now, but of course it never hurts to ask.

                                                            • August 18, 2016 at 10:16 pm
                                                            slh4448
                                                            Participant

                                                              Thanks all for your comments. I actually asked my med onc who is going to start me on Vervoy 3mg next week if I could have the ipi/nivo combo and he said no because he is treating me adjuctantly with a single agent.

                                                              Now I know from reading about nivo that a stage 3 person can get this drug if they have a unresectable tumor/cancer. I had surgery and only one lymph node removed from the snlb, which was positive, but not doing the clnd. My thought is and another question that I will ask my med onc is why can't he write for the combo "off-label"? Docs use drugs all the time off-label. Just curious and maybe it is a hard no and that's the way it is, but won't hurt to ask, right?

                                                              Both drugs made by BMS so "maybe" easier to get off-label than two drugs from two different manufacturers??? I'm just thinking out loud here and certainly welcome any more comments fro you guys!!

                                                              Thanks,

                                                              Stacy

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