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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM)

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To: Ian@SI who wrote (2669)6/22/2006 8:46:30 AM
From: tom pope   of 3044
 
Merrill's take:

More positive data for Velcade in front-line MM
MLNM announced positive data from a 60-patient open-label phase I/II trial of
Velcade in combination with melphalan and prednisone (V-MP) vs. MP in elderly
(60-85yrs) patients with newly diagnosed multiple myeloma who were ineligible
for stem cell transplants. Velcade combination regimens have consistently shown
encouraging data in the front-line setting and we expect interim data from at least
one of 3 ongoing phase III trials in front-line multiple myeloma by YE 2006. But
from a competitive standpoint, an all oral regimen will likely have an advantage in
the front-line setting, particularly in the elderly. Maintain Neutral.
Consistently high response rates in front-line MM
The phase I/II data for V-MP showed a complete response (CR) rate of 32%, a
near complete response (nCR) rate of 11% and an overall response rate (ORR) of
89%. These are at the high end of prior data for various Velcade combination
regimens in the front-line setting that have shown CR’s in the 20-33% range and
ORR up to 95%.
Velcade in 3 phase Ill trials in front-line multiple myeloma
Velcade is currently in 3 phase III combination trials in the treatment of front-line
multiple myeloma, including the VISTA trial, initiated in 1Q05, which is assessing
the V-MP regimen. We expect interim data from at least one of the phase III trials
by year-end 2006.
But, oral regimens may have advantage in the elderly
The reported Velcade data in the elderly is impressive, but from a competitive
standpoint, an all oral regimen such as R-MP (Revlimid, melphalan, prednisone),
which is entering phase III later in ‘06, may have an advantage in elderly patients.
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