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Ann: Recruitment of stage 1 of part B in TACTI-002 study complete, page-16

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    @isabella8685, my-to-be-lotto-winning-best-friend ....

    To put significance of this in perspective I try to paint a bit of picture:

    This Phase II study is in 3 parts; A, B and C, each involving two stages 1 & 2 to allow data monitoring/review in between before moving to stage 2 from stage 1. That means if the drug makes it to stage 2 that is good news!

    Now, this announcement tells us only stage 1 of part B recruitment has completed but ... lets go back a bit. Here is what different parts are:

    Part A: Efti (IMP321) as only (1st) line of treatment for patients with late stage lung cancer - The 1st and 2nd stage completed.

    Part B: Efti (IMP321) as 2nd line (still in combo but sequentially) after failure of a first-line treatment (for metastatic disease).

    But first things first in terms of significance. Recruitment continuing or completing means (a) the patients are surviving and (b) there has been no significant adverse effect to suggest an intervention, meaning PROGRESS as hoped/planned/expected.

    Then Part A having (a) passed through the data monitoring/review point AND (b) completing 2nd stage and (c) positive results, means Efti passed safety and efficacy when used as a 1st line treatment for the same (late stage) disease. And now Part B stage 1 completing, all indicates the likely direction is to stage 2 and if that happens then it all meaning things are PROGRESSING as hoped/planned/expected.

    There is also Pat C, stage 1 completed, data monitoring/review passed, stage 2 recruiting. While Part C is for patients with Heand & Neck cancer, i.e., different cancer to Part B (& A), it still uses the same IMM's drug (Efti/IMP321) as for Part A & B with same combo as 2nd line.
    Last edited by tuts: 18/08/20
 
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