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IPI Fast Tracked by FDA

Forums Cutaneous Melanoma Community IPI Fast Tracked by FDA

  • Post
    Jerry from Cape Cod
    Participant

    Promising Treatment for Metastatic Melanoma 'Fast Tracked' by FDA

    Sep 9, 2010 12:34:00 (ET)

    HACKENSACK, N.J., Sept 09, 2010 /PRNewswire via COMTEX/ — Researchers from the John Theurer Cancer Center at Hackensack University Medical Center played an important role in a study that led to the Food & Drug Administration's (FDA) recent fast tracking of ipilimumab, a promising treatment for metastatic melanoma. The FDA based its decision largely on the results of a pivotal study published in the New England Journal of Medicine on August 19, 2010 – the same day the agency accepted Bristol-Myers Squibb's application for the drug's approval and granted the application priority review status.

    Ipilimumab is the first drug shown in randomized, placebo-controlled trials to improve survival in stage IV melanoma.

    "This study, and the FDA's decision, provides new hope for people with this devastating cancer," said Andrew L. Pecora, M.D., F.A.C.P., C.P.E., Chairman and Executive Administrative Director, John Theurer Cancer Center, who led the study at the John Theurer Cancer Center. "We are proud to have played a role in helping move another promising cancer treatment closer to market."

    The incidence of metastatic melanoma has increased over the last three decades, and the death rate continues to climb faster than that of most other cancers. According to the American Cancer Society, there were approximately 68,000 new cases of melanoma in the United States in 2009, and 8,700 melanoma-related deaths. Melanoma accounts for about three percent of all skin cancers, but 80 percent of skin cancer deaths. Melanoma is difficult to treat once it has spread beyond the skin to other parts of the body (metastasized). Very few treatment options exist for people with metastatic melanoma.

    In this phase III study, researchers randomly assigned patients to one of three treatment groups: those receiving ipilimumab plus an inactive (placebo) version of gp 100, a cancer vaccine; those receiving ipilimumab plus gp 100; and those receiving gp 100 plus ipilimumab placebo. The treatments were administered once every three weeks, for a total of four treatments. The study was double blinded: neither the researchers nor the patients knew which medications the patients were being given.

    To participate in the study, patients must have had stage III or IV (metastatic) melanoma, and must have been previously treated unsuccessfully with another cancer drug. They must also have had a life expectancy of at least four months. 676 patients participated in the study at 125 cancer centers.

    Those who received ipilimumab, both by itself and with gp 100, lived a median of about 10 months, while those who received only gp 100 lived about 6.4 months. After two years, approximately 23 percent of those who got ipilimumab were alive, while 14 percent of those who did not receive this drug survived. Ten to 15 percent of those who received ipilimumab suffered attacks on their bodies' immune systems (autoimmune reactions), and seven of the 540 patients who got this drug died from these attacks. Most adverse events suffered by study participants, however, were reversible with treatment.

    A monoclonal antibody, ipilimumab activates the body's immune system to fight cancer by blocking a protein called CTLA-4. CTLA-4 is a molecule on T-cells, white blood cells that play a critical role in regulating immune responses. CTLA-4 suppresses the immune system's response to disease, so blocking its activity stimulates the immune system to fight the melanoma.

    The FDA grants priority review status to drugs that offer major advances in treatment, or that provide treatment where no adequate therapy exists. The projected FDA action date for the ipilimumab application is December 25, 2010.

     

    -end

     

    Jerry from Cape Cod

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  • Replies
      Kevin from Atlanta
      Participant

      Jerry,

      Do you have any idea of what percentage of people on Ipi are late responders? I forgot to ask that question at the oncologist.

      After 4 treatments, mine grew.

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        jag
        Participant

        Kevin, how long has it been since your 1st treatment? Ipilimumab was first thought to be not so effective because initially the tumors would appear to grow, when what was actually happening was the immune system was attacking the tumors, causing them to swell.  Ipi can take awhile to show long lasting results, it has crossed the blood brain barrier as well.  Since I think I remember you mentioning having had some radiation in the past, that can also cause necrosis.  If you have no new tumors, I wouldn't panic yet.  Easy for me to say, I guess, sometimes the hardest thing can be the waiting.  

        Will keep you in my prayers.

        John

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        jag
        Participant

        Kevin, how long has it been since your 1st treatment? Ipilimumab was first thought to be not so effective because initially the tumors would appear to grow, when what was actually happening was the immune system was attacking the tumors, causing them to swell.  Ipi can take awhile to show long lasting results, it has crossed the blood brain barrier as well.  Since I think I remember you mentioning having had some radiation in the past, that can also cause necrosis.  If you have no new tumors, I wouldn't panic yet.  Easy for me to say, I guess, sometimes the hardest thing can be the waiting.  

        Will keep you in my prayers.

        John

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      Kevin from Atlanta
      Participant

      Jerry,

      Do you have any idea of what percentage of people on Ipi are late responders? I forgot to ask that question at the oncologist.

      After 4 treatments, mine grew.

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      DebbieH
      Participant

      When you actually read the numbers, we need to hope and pray for something that will help more people. 

      I know this is going in the right direction, and I'm glad for that.  But I have a hard time cheering for something so toxic that can give us an extra 3.6 months.  On the bright side, hopefully the 165 people or so that are still living out of those 676 can change those numbers and keep going!  Let's hope this is the start of something good.

      DebbieH

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        Jerry from Cape Cod
        Participant

        When you're stage IV and the doc says your options are if you do plan A you die if you do plan B there's a chance to extend your life, no guarantees.  The side effects for the majority are managable.  The level III trial you used as a basis had different arms with varying treatment.  The true issue is that there will have to be multiple treatments that work for different segments of the patient population just like there are for other cancers. 

        There are no magic bullets or simple answers, it's a miserable disease that needs to be attacked from many different directions.

        Jerry from Cape Cod

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        Jerry from Cape Cod
        Participant

        When you're stage IV and the doc says your options are if you do plan A you die if you do plan B there's a chance to extend your life, no guarantees.  The side effects for the majority are managable.  The level III trial you used as a basis had different arms with varying treatment.  The true issue is that there will have to be multiple treatments that work for different segments of the patient population just like there are for other cancers. 

        There are no magic bullets or simple answers, it's a miserable disease that needs to be attacked from many different directions.

        Jerry from Cape Cod

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        jag
        Participant

         

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        jag
        Participant

         

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      DebbieH
      Participant

      When you actually read the numbers, we need to hope and pray for something that will help more people. 

      I know this is going in the right direction, and I'm glad for that.  But I have a hard time cheering for something so toxic that can give us an extra 3.6 months.  On the bright side, hopefully the 165 people or so that are still living out of those 676 can change those numbers and keep going!  Let's hope this is the start of something good.

      DebbieH

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      Jim M.
      Participant

      Hi Jerry,

       Thanks for posting this. It gives me hope that our experience (yours, mine, others) with Ipilimumab will benefit the lives of many others to come. That is worth celebrating!

       God Bless,

       Jim M.

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      Jim M.
      Participant

      Hi Jerry,

       Thanks for posting this. It gives me hope that our experience (yours, mine, others) with Ipilimumab will benefit the lives of many others to come. That is worth celebrating!

       God Bless,

       Jim M.

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      Lori C
      Participant

      Thank you for posting this.  I am still hoping that Will may get a chance to try ipi.  He's still responding to the chemo, tumors getting gradually smaller.  If this continues long enough perhaps ipi or Oncovex is an option for him.  My fight with BMS over this is pretty well documented here : )   Knowing this is going to be FDA approved (likely) very shortly gives me more hope – and hope is "that thing with feathers", after all –

      Hope     

      Hope is the thing with feathers
      That perches in the soul,
      And sings the tune–without the words,
      And never stops at all,

      And sweetest in the gale is heard;
      And sore must be the storm
      That could abash the little bird
      That kept so many warm.

      I've heard it in the chillest land,
      And on the strangest sea;
      Yet, never, in extremity,
      It asked a crumb of me.

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      Lori C
      Participant

      Thank you for posting this.  I am still hoping that Will may get a chance to try ipi.  He's still responding to the chemo, tumors getting gradually smaller.  If this continues long enough perhaps ipi or Oncovex is an option for him.  My fight with BMS over this is pretty well documented here : )   Knowing this is going to be FDA approved (likely) very shortly gives me more hope – and hope is "that thing with feathers", after all –

      Hope     

      Hope is the thing with feathers
      That perches in the soul,
      And sings the tune–without the words,
      And never stops at all,

      And sweetest in the gale is heard;
      And sore must be the storm
      That could abash the little bird
      That kept so many warm.

      I've heard it in the chillest land,
      And on the strangest sea;
      Yet, never, in extremity,
      It asked a crumb of me.

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