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Biogen Inc. Message Board

  • ERNIEOSD ERNIEOSD Apr 24, 1998 12:53 PM Flag



    WE ARE DYIN' HERE!!!!!!!!!!

    COME ON GUYS..............................

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    • You raise interesting point about the greater
      safety risk of hot mabs. But we don't have direct
      comparison of hot and cold safety vs efficacy, except
      coulter comparing their own. I mean we don't have a
      direct comparison of Rituxan, which may be better than
      Coulter's cold (or may not be, but it is on the market) and
      Bexxar which may be headed for market. Also, where did
      you see the 5.3% Bexxar platelet < 10K figure? Was
      it in the published phase II article? It is true
      that transfusions are an added expense, but also very
      common with chemotherapy. Coulter was careful to point
      out today that these "heavily pre-treated" patients
      had already been through the wars, so the implication
      is nobody should be surprised. In my father's case,
      he got into the Bexxar study with barely the minimum
      blood counts. He did need platelet and whole blood
      transfusions. The HMO paid for transfusions and did not even
      blink. (They will not pay for experimental treatment,
      but will pay for supportive care that is comparable
      to that needed for chemo, if you manage to get in a

    • to everybody for taking the time to discuss and
      answer my questions. Now I understand why I was asked --
      first question, before anything else -- what my
      platelet count was, when I applied to Bexxar trial and to
      Rituxan-with-yttrium trial.

      All of you are terrific!

    • Thanks for posting the randomized trial info
      comparing hot antibody (Baxxar) vs. cold antibody
      (anti-B1). The interim efficacy result came in no surprise
      in favor of hot antibody because the radiolabelled
      antibody usually penetrates thru tumor cells more
      effectively. However, one should not forget what these
      patients need to suffer. i.e. Patient will definitely
      experience more severe hemotologic toxicities when treating
      with hot antibody. For example, 5.3% of the
      Baxxar-treated patients experienced platelets of 10,000 means
      that these patients need immediate platelet
      transfusion in the hot antibody therapy. I don't know if the
      medical cost can be justified if the insurance company
      will pay $8K-10K for the hot antibody in addition to
      the cost of platelet transfusions. I think it is
      going to be critical for the FDA advisory board members
      to access the risk and benefit of the two type of
      approaches before they can jump into any conclusions. BETTER
      response rate can accompany by a longer duration of
      response, the hot antibody will be in favor. Otherwise, it
      may be better off with cold antibody first before try
      hot antibody therapy.

    • Bob: You have raised some interesting points
      that, in my myopia, I hadn't thought about. If you've
      been reading these threads, you know I have NHL and
      have been trying to get into various trials. I had
      been thinking of these treatments as overlapping, and,
      of course, there's no reason they should. (What I
      mean by that is that if you responded to one you would
      respond to another, and if you failed at cold you would
      have a better chance with hot and vice-versa.) I see
      now that there could be a large variety of
      combinations of various kinds of treatment with various kinds
      of patient types that might lead to success in one
      case and not in another. Thanks for pushing my
      thinking into another direction. And even though your
      information is anecdotal and second-hand, you're not
      publishing in a scientific journal here, and as long as we
      all know from whence it came, it's most useful and
      most helpful.

      Oexwiz: Yttrium's getting to the
      bone worries me. I've had numerous regimens of
      treatment which included strong doses of steroid (part of
      standard treatment for NHL, both with and without other
      chemotherapy). Steroid also affects the bone. And for a female
      my age (I'm older than my tag line says -- I've been
      aging while watching Techniclone go through its
      throes), that's very worrisome. But my doctors don't seem
      to be as concerned as me (they never are) and they
      all seem to be ready to put me on Rituxan with
      yttrium as soon as I have a relapse.

      I was also
      under the impression that with the ease-up from the
      Nuclear Regulatory Agency regarding whether or not Bexxar
      patients had to be isolated, that they could be given
      treatment, which includes radioactive iodine, and go home.
      If I remember correctly, as soon as that ruling
      became public, Coulter's stock started going

      So maybe it's a choice between glowing in the dark
      and contaminating all around you, or getting
      osteoporosis and breaking your hip. Some think anything's
      better than cancer, but having been there, I'm not so
      sure about that. Side effects do matter.

      to both of you for responding to my posts.

    • Berblady, you may have caught me doing a "Davis"
      here, in that I have repeated second hand reports that
      can't be verified by anything in print. A university
      researcher who treated patients in both the rituxan and
      bexxar trials told me "some" patients who had little or
      no response to bexxar did respond later to rituxan,
      including one patient he personally treated. (This
      university only did a handful of bexxar treatments. But I
      was under the impression that there were other
      similar cases at other test sites.) When we consider the
      variable nature of these diseases, we shouldn't assume
      that the 40% of people who respond to rituxan are also
      part of the 60% who respond to bexxar. (Or whatever
      the exact numbers are.) They may not completely
      overlap. It may be that for some people, several
      treatments of cold is better than one or two of hot. This
      may be one reason why Coulter thought it wise to go
      back and get some hot vs cold data, even though it
      might not be directly related to FDA approval. Or I may
      be all wet. We'll just have to wait and see.

    • Thanks, Bob, for your comments. As usual, they're
      worthwhile. I didn't know that some people who didn't respond
      to hot did respond to cold. Time will tell.

      don't know how to scan, or whatever it is you do to get
      a whole document onto the screen, so I'm going to
      type what I think were the relevant parts of the Oct.
      20, 1997 press release.

      Business Wire 1091,
      Oct. 20, 1997

      Coulter Pharmaceutical Compares
      Bexxar to Unlabeled Monoclonal
      Antibody for
      treatment of Non-Hodgkin's Lymphoma.

      Palo Alto,
      Calif .... Coulter announced preliminary
      clinical data from a trial comparing the company's Bexxar
      .... to its unlabeled anti-CD20 monoclonal antibody in
      patients with low-grade non-Hodgkin's lymphoma.

      trial is designed to assess the therapeutic benefit of
      adding the radioisotope to the anti-CD20 monoclonal

      The interim data, which are being presented at this
      week's American Society for Therapeutic Radiology and
      Oncology meeting, indicated that Bexxar therapy is
      demonstrating a trend toward higher response rates compared to
      the unlabeled monoclonal. In addition, both Bexxar
      and the unlabeled antibody were well-tolerated.
      However, more patients in the Bexxar-treated arm
      experienced transient and reversible low blood cell

      (Then there's a paragraph about how wonderful it all

      The preliminary data were generated from 15 patients
      of a planned 78-patient randomized, controlled Phase
      II clinical trial and were presented by Susan Knox,
      M.D., Ph. D., associate professor, Radiation Oncology
      at Stanford University Medical Center and a
      principal investigator for the clinical trial.

      trial is being conducted in low-grade, non-Hodgkin's
      lymphoma patients with chemotherapy refractory NHL who
      have progressed within one year after completing their
      last chemotherapy regimen. Patients are randomized 1:1
      to receive either Bexxar therapy or the unlabeled
      monoclonal antibody specific for the CD20 antigen found on
      NHL cells.

      Dr Knox reported that 75 percent
      (six of eight) of the patients randomized to the
      Bexxar arm responded to the therapy, compared to only 43
      percent (three of seven) of patients who responded to the
      unlabeled antibody. Two of the patients in the Bexxar arm
      experienced a complete remission of their disease while only
      one patient in the unlabeled antibody arm achieved a
      complete remission.

      (End of direct

      It goes on to talk about progression, what it all
      means, what Coulter does, etc. Then:

      "Coulter has
      generated clinical data using Bexxar in all stages of
      low-grade, non-Hodgkin's lymphoma, including patients at the
      time of diagnosis as well as patients in late-stage of
      disease who are refractory to chemotherapy and require
      salvage therapy."

      They go on to say that they plan
      to complete their Phase II/III multicenter trial
      with Bexxar, which was completed recently, and about
      which we'll probably hear at the coming clinical
      oncology meetings.

    • You asked for comments. Here are mine, for
      whatever they may be worth. Hot seems to work better for
      more people than cold. However, cold works for some
      people where hot failed. In other words, Rituxan has
      produced significant responses in people who didn't get
      much from Bexxar. Maybe this will be a small
      population, though. The ability to administer cold in any
      chemotherapy outpatient clinic, without nuclear medicine
      staff, means it will be cheaper and more readily
      available. Perhaps a lot of patients will be encouraged to
      try cold before hot.

    • Is it possible for you to post that press release
      in the thread ? As far as I know, the pivotal trial
      that Coulter is planning to submit for US approval is
      an open-label, single-arm trial without any active
      control group in the study. Why would Coulter want to
      conduct a randomized trial but not use for the
      submission. IMHO, Coulter might have some concern about the
      randomized trial that Suan Knox is currently conducting.

    • While waiting for some news about conference next
      week (I thought the abstracts would be made public
      this week, but haven't heard or seen hide nor hair of
      them), I looked back through some of my files. The
      following is not meant to throw cold water on our optimism
      re IDEC, but to keep us sharp about what IDEC's
      facing as to competition.

      A Coulter press
      release, dated Oct. 20, 1997. Presents preliminary
      clinical data from a trial comparing Bexxar to its
      unlabeled anti-CD20 monoclonal antibody in patients with
      low-grade NHL. Study is a planned 78-patient randomized,
      controlled Phase II clinical trial by Susan Knox, MD, PhD,
      Stanford University Medical Center. Hot monoclonal was
      better than cold. This suggests a couple of things. 1)
      If cold is needed before hot, Coulter can do that.
      2) If you want to prove that hot is better than
      cold, Coulter seems to be doing that, not just with
      possibly not comparable statistics, but in a
      scientifically controlled design. I haven't heard more about
      this study. Will we hear more next week?

      from my Coulter files: Press release dated Jan. 30,
      1998. Bigham, president and CEO of Coulter, said (among
      other things) "We also began manufacturing Bexxar at a
      central facility and shipping the therapy in a
      convenient, ready-to-use formulation."

      Any comments?

    • Any idea of timeline for data on this and rutuxin and chemo combination?

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