Trawling through all the reports & trying to remember & compare...

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    Trawling through all the reports & trying to remember & compare critical values - to help assess relative effectiveness of Cavatak versus Amgen’s T-Vec, is frustrating.

    So, I’ve tabulated available data on Cavatak versus T-Vec – together with some parameter definitions.

    If others can fill in any blank fields, please post data in this thread – along with info source. Presumably data for many of these will be supplied at ASCO in June 1.

    Summary conclusion is: VLA looking very competitive.

    Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Column 8 Column 9 Column 10
    0
    Treatment ►

    Cavatak

    T-Vec

    Biovex OncoVex Phase 2 Melanoma. Final data



    Average results from trials of 40 anti cancer drugs on patients with Stage 3 & 4 melanoma

    1
    Reference ►

    VLA 30 Jan 2014

    VLA. 2 June 2014

    VLA

    29

    Sept 2014

    VLA

    21

    April

    2015

    VLA.

    30 Jan 2014

    Edison Rpt. Aug 2 2013

    2
    Parameter


    As at July 2013

    As at Sept 2013

    As at Nov 2013

    As at Jan 2014

    As at June 2014

    As at

    Sept

    2014

    As at April 2015



    3
    % patients demonstrating immune related progress free survival at 3 months after first dose

    60

    18/30

    NR

    50

    19/38

    NR




    50


    4
    % patients demonstrating

    irPFS

    immune related progress. free survival at 6 months after first dose

    35

    8/23

    33

    10/30

    34

    12/35

    35

    14/40

    37

    19/51

    38.6

    22/57

    38.6

    22/57

    This is twice the initial target

    19

    = Durable response rate from Stage 3 trials.?

    Over what term??

    15

    5
    % overall response rate

    27

    8/30

    NR

    24

    9/38

    NR

    26

    15/57

    28

    28

    16/57

    26

    13/50

    Ex stage 2 trial


    6
    1 year survival rate

    NR

    NR

    56

    9/16

    60

    12/20

    63.6

    21/33

    73

    33/45

    75

    36/48

    58


    7
    Response lasting at least 6 months








    92%

    Ex stage 2 results


    8
    Complete response








    20%

    Ex stage 2 results




    IMMUNE RELATED, PROGRESSION FREE SURVIVAL (irPFS)

    irPFS = complete response, partial response (more than 30% drop in size of tumours)
    and stable disease

    So far 22 patients have reached the point where immune-related progression free survival (irPFS) can be measured at six months. This measure of progression free survival is adapted for immunotherapies - where it is accepted that the tumours may initially
    continue to grow as the immune response takes effect, which is somewhere between six to 10 weeks in the injected lesion. Responses have been seen as late as nine months after initial treatment in metastatic (non-injected) lesions. In this trial patients
    are injected with the CAVATAK virus directly into some melanoma lesions. The minimum goal in this key measure was to get 10 of the (initially planned total of) 54 patients to reach irPFS at six months, meaning that after six months the person's cancer has been held controlled.

    % OVERALL RESPONSE RATE
    I take it that this is the same as the “Objective response rate”
    My take from Edison is that this is measured by the number of patients who have achieved greater than 30% reduction in size of all tumours in the body



 
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