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  • thirdmeinvestor thirdmeinvestor Jan 14, 2006 6:45 AM Flag

    Cynical About Simultaneous Announcement

    Iressa is very well studied and it will serve as a good standard. As long as ASSIST 2 trial documents EGFR protein kinase mutation or skin rash status, it will be OK. Oncologists including TJ Lynch of MGH and Harvard Med have high opinions about Iressa. Last year, Lynch said that he was hopeful that Iressa would eventually be resurrected by FDA. Subpopulations of NSCLC tumors(Asian or tumors with EGFR pk mutations) respond remarkably well. The response rates among Japanese and Chinese patients are as high as 60-80%. The overall survival rate is comparable to Tarceva for the subpopution with pk mutations. A problem I see is that the size of the trial is only 200 and it will include only about 16 patients (8%) with the mutation.

    The real killer application of Telcyta is the triplet or doublet combo against NSCLC, of course. The small studies announced last May
    were remarkable. One of the study was led by Lynch mentioned above.

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    • > A problem I see is that the size of the trial is only 200 and it will include only about 16 patients (8%) with the mutation.<

      If this percentage relates to those with BAC in the NSCLC population, then it should be noted that patients with BAC are excluded from this trial.

      Also, investors scrutinizing the ASSIST-2 trial (which they should) must also realize that at the time of its design, Tarceva was not available in the US or other countries. In fact, ASSIST-2 was announced one month before the successful Tarceva phase III NSCLC results.

      So I'm not sure there is much to criticize with respect to the *design* of the trial. Now whether the trial *results* are as relevant today as they would have been 2 years ago is a matter for individual investors to decide for themselves.

      • 3 Replies to poorgradstudent
      • Poorgrad

        Since I own both TELK and MLNM I check boards and noticed you just posted on both sites. Do you own any other biotechs?

        thanks

        smalltownzus

      • The easiest way to show the efficacy of Telcyta is to show that it is as good as or better than the best case for I or T. I or T works best for the tumors with the mutation, which is linked to good response to I. The occurence rate of the favorable mutation is only 8%. My point was a possible mutation documentation would not do the job. However, the rash rate for I is around 60%. So, this marker could be used to compare the two arms. I was trying to point out that the trial is NOT a 'damaged good'.

      • ASSIST-2 was fine as designed. Tarceva was
        not available then as poorgradstudent points
        out. I probably should have said this explicitly
        but I think mostly everyone is on the same page.

        More is known about Iressa at this point
        and consequently it's hardly the best benchmark - anymore.
        Consequently: damaged good.

        It's a case of OBE: overtaken by events.

        The whole NSCLC situation is different than
        when this study went into play.

        Again, my main point is that ASSIST-1 is
        the study to watch and probably the gating
        study in any case.

 
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