From time to time I visit yahoo MLNM board. Baronate and poorgradstudents posts are worth reading, imo.
The question is how will MLNM designee front-line trial(s)? I guess, few of my guesses (respond to PG) are worth repeating here.
finance.messages.yahoo.com
PG,
So far data indicate that V is highly synergistic with PEG-DOX, and APER trial indicate that V+DEX works better in combination than each alone (otherwise Pts will turned completely to V-only arm, not be adding V to what they are receiving now). So, direct comparison of the V+VAD to VAD as frontline therapy is one option for MLNM.
However, T + DEX in combination with and without V is second option. MLNM will have some safety data on V+T combination (ongoing trials), so FDA and leading oncologysts can not be simple blind for this option, regardless that T is not approved for any MM (and will not be in near future).
Due to facts that most likely than not T will go generic in 2005/6, FDA can not stop penetration of the T in front-line and second-line approach to treat MM. In this case I will go with T+V+Dex (all in reduced dose) as one arm , V + D as second arm, and VAD+ D as control arm. After this regime failed or Pts relapse one can try (as second line) higher chemo dose and higher V dose without fear that Pts will be refractory and non-responsive to chemo-V combination.
Lastly, I do not see T as direct V competitor. After going generic overall treatment price due to T component will be reduced by 20-25%, so commercial component will be important to MLNM and J&J.
All those are only my current best guess. Front line trial will last at least 24 months (before preliminary data will be known, survival and re-treatment option), and many things can change in next 24 months. This is thought business, and to survive one need to have many back-up options available.
Miljenko
PS: Also, I will go for superiority. All or nothing! |
