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In transition, I plan to update my Bio in the near future. -- Justin
  • Treanda® plus Rituxan® followed by Zevalin® - New Standards for NHL & Indolent Lymphoma 10 comments
    Feb 1, 2010 11:26 AM | about stocks: SPPI, CEPH, BIIB, RHHBY
    ASH 2009
    Treanda (bendamustine) plus Rituxan (rituximab) offers new standard of care for NHL and indolent lymphoma

    Indolent Lymphoma & AML
    • Treanda plus Rituxan was shown to be better tolerated and improved progression-free survival (NYSE:PFS) compared with standard CHOP plus Rituxan (CHOP-R) as first-line therapy for indolent lymphoma in a multicenter, randomized, controlled trial conducted by the German Study Group on Indolent Lymphoma (StiL).
    • Studies also demonstrate steady progress in elderly patients with acute myeloid leukemia (AML). The results indicate that one cycle of post-remission therapy extended survival in elderly patients with AML.
    • 549 symptomatic patients (splenomegaly, pain, large tumor burden) enrolled at 82 centers, with a median age of 64 years.
    • Patients were randomized to either Treanda plus Rituxan (T/R) or CHOP-R.
    • Of these, 513 patients were evaluable for toxicity and efficacy. 
    • Histologies were distributed equally between T/R and CHOP-R.
       


    Improvement in Progression-Free Survival

    Source: CancerNetwork

    ASH 2008

    Landmark Study: first-line consolidation therapy with Zevalin (yttrium-90-ibritumomab tiuxetan)

    Indolent Lymphoma
    • 414 patients from 77 medical centers throughout the EU
    • Patients received a variety of induction therapy regimens, which included different chemotherapy agents and, in approximately 15% of patients, also included the monoclonal antibody Rituxan® (rituximab).
    • After induction therapy, patients were randomized to no consolidation therapy or consolidation with a two-course “priming” dose of Rituxan followed by a single dose of Zevalin.
    • The results showed that consolidation therapy – a form of adjuvant therapy after initial or “induction” therapy to induce remission – with a single dose of Zevalin significantly improved progression-free survival in all patient subgroups compared to patients in the control arm, who only received induction therapy.
    • Dr. John Leonard, director of the Center for Lymphoma and Myeloma at Weill Cornell Medical College in New York, its good safety profile and the fact that it is well tolerated by patients makes Zevalin “particularly attractive for [use in] older patients,” who may not handle more toxic chemotherapy regimens very well.

    Improvement in Progression-Free Survival (PFS)


    77% PR to CR Conversion Rate
    • 77% of the patients, who received a partial response (PR) to induction therapy “converted” to a complete response (NYSE:CR) after receiving Zevalin.
    • According to investigators at the Universitair Medisch Centrum Utrecht in the Netherlands, the team responsible for analyzing the Zevalin study, “[t]his constitutes one of the highest PR-to-CR conversion rates reported in published phase 3 randomized studies in first-line follicular lymphoma.”
    Source: NCI Cancer Bulletin, Vol.5 No.21 October 21, 2008.


    THE PLAYERS

    • Treanda is marketed by Cephalon (NASDAQ:CEPH).
    • Rituxan is marketed by partners Biogen Idec (NASDAQ:BIIB) and Roche-Genentech (OTCQX:RHHBY). 
    • Zevalin is now marketed by Spectrum Pharmaceuticals (NASDAQ:SPPI).

    Q
    . Will Treanda affect Zevalin?


    Zevalin is already FDA approved for first-line consolidation therapy, which follows induction therapy (combo of Chemo and Rituxan). As I can tell, Treanda would fit into induction therapy and responsible for breaking down the bulky cancer, whereas Zevalin is administered after induction therapy and cleans up the residual cancer. Zevalin converts PRs to CRs and ultimately improves PFS and OS. Generically speaking, Zevalin eliminates the likelihood of recurrence for most patients. So, Zevalin is a cure for most patients.

    If anything, the two drugs, Zevalin and Treanda, would most likely be used together in different stages to treat patients with NHL. Example: Treanda would be administered during induction therapy along with Rituxan and consolidation therapy with Zevalin would follow.

    Therefore, I view Treanda and Zevalin more as allies in the war as opposed to foes or competitors.


    Disclosure: Long SPPI.
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Comments (10)
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  • Betsy de Parry
    , contributor
    Comments (5) | Send Message
     
    Hi Jason,

     

    I agree with you that Zevalin, chemo or Treanda should be allies. Most importantly, studies have shown that achieving a complete remission (CR) is an important factor in increasing the duration of remission periods and for improving the survival of patients. Several studies have also shown that RIT produces the highest CR rates as well as the longest periods of remission, often measured in years. Additional studies such as the ones you mention are adding to that growing body of evidence. Thus I believe - and deeply hope - that consolidation therapy will find greater acceptance - which of course translates in more sales for the company.

     

    Betsy

     

    Betsy
    1 Feb 2010, 07:33 PM Reply Like
  • horse625
    , contributor
    Comments (16) | Send Message
     
    thanks, seems that SPPI's current price is under pushing down for a take over of the company. Let's see.
    2 Feb 2010, 05:58 PM Reply Like
  • horse625
    , contributor
    Comments (16) | Send Message
     
    SPPI's new deal sucks! Raj is hungary for cash or what?
    2 Feb 2010, 07:13 PM Reply Like
  • Justin M. Hall
    , contributor
    Comments (753) | Send Message
     
    Author’s reply » Betsy:

     

    Regarding the adoption of RIT via consolidation therapy, the somewhat limited feedback that I have received has been positive. I do believe shift is occurring.

     

    I always appreciate your comments. Thank you!

     

    Justin
    18 Feb 2010, 04:43 AM Reply Like
  • Justin M. Hall
    , contributor
    Comments (753) | Send Message
     
    Author’s reply » Horse:

     

    I like the addition of this particular drug. I believe it will prove to be a smart move down the road. This drug appears to be similar in some ways to ALTH's drug PTX (my abbreviation for the drug).

     

    With all four of its late-stage cancer drugs approved by 2012- a long shot - SPPI will look more like a Biogen Idec (BIIB) or maybe even a Celgene (CELG). While not a total impossibility, it's very wishful thinking.

     

    Horse, we shall see my friend.

     

    Justin
    18 Feb 2010, 04:54 AM Reply Like
  • beachmimi
    , contributor
    Comment (1) | Send Message
     
    I received zevalin tx in 1/20011 and had a good partial response, but a new tumor was found on pet scan. Would I be a canadidate for treanda?
    29 Mar 2011, 01:07 PM Reply Like
  • Justin M. Hall
    , contributor
    Comments (753) | Send Message
     
    Author’s reply » I encourage you to consult with your treating doctor.
    29 Mar 2011, 04:46 PM Reply Like
  • kidsandliz
    , contributor
    Comment (1) | Send Message
     
    One problem is that Bexxar does a better job of advertising than Zevalin which is unfortunate. This, in my opinion, is the biggest error this company is making with this drug (and a very fixable error). In addition, according to my oncologist, the makers of Zevalin are no longer making it on demand, rather only twice a month which as a patient is a pain in the rear. I am trying to time the bone marrow crash and have now partly lost the ability to do so. Makes me think about considering Bexxar even though Bexxar (but not Zeavlin) risks your thyroid...

     

    From the investor side someone needs to get after this company to more aggressively market their drug. Lack of marketing is going to kill them, rather than lack of efficacy of the drug - it is very, very effective for many patients. They need to advertise studies like this, address the MD fears of long term bone marrow suppression and potential effects on a future stem cell transplant (I know some patients who have had Zevalin both before and after a stem cell transplant so there is probably some data out there, if not there needs to be and perhaps tracking the people in this study - and others like it - will provide the data). The marketing need to be both to the doctor (especially the doctors who write the standards for treatment - that would be really cost effective to target them as there are no that many - along with the major non-Hodgkin's lymphoma centers in the USA since most of us at least go to one for a second opinion so this would be cost effective as well) and to the patient (via the non-hodgkin's lymphoma yahoo group, the website that listowner keeps www.nhlcyberfamily.org/ which is a wealth of information about this disease, and support to other patient boards with ads. *I* am the one who found out about this and brought it to my doctor's attention.

     

    As your first poster said, Treanda and Zevalin are not competitors - they are complementary.

     

    I am a patient (follicular non-Hodgkin's lymphoma) who just finished Rituxan/Treanda and am waiting for my counts to recover to do Zeaviln. I have a PhD in business.
    24 Apr 2011, 02:11 PM Reply Like
  • calep1954
    , contributor
    Comment (1) | Send Message
     
    I have agressive NHL which is in remissionvia Rituxan. It will come back. They will then use Treandra with Rituxan. Major problem is I have a bone marrow disorder. My white count is 2000, and my neutrophil count is 450.My platelets and red count is marginally normal I will get neulasta prior to injection but what are the chances of my survival with my blood count being what it is?What % reduction of WBC can I expect? Thanks for any info you can give me
    27 Feb 2012, 02:56 PM Reply Like
  • Justin M. Hall
    , contributor
    Comments (753) | Send Message
     
    Author’s reply » Calep1954, I apologize for responding so late. For whatever reason, I did not catch your comment.

     

    I would strong recommend that you contact my friend Betsy de Parry, a NHL survivor and patient advocate. She is inspiring - a good person doing good things. I would visit her site at: http://bit.ly/GIqcCQ As I recall, you can contact her directly from the site.

     

    I do hope this helps and wish you a very speedy remission.

     

    Justin
    21 Mar 2012, 10:09 AM Reply Like
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