Merrill:
Interim IFM phase III data consistent with phase II
Preliminary interim phase III data from the IFM study of Velcade in combination
with dexamethasone vs. VAD (vincristine, adriamycin, dex) as induction therapy
prior to autologous stem cell transplant (ASCT) in newly diagnosed multiple
myeloma patients presented at ASH (Amer. Soc. Hematology) was consistent
with prior phase II data showing Velcade/dex had a higher response rate. But it
would be competing with the all oral regimen of Thalomid/dex (and likely
Revlimid/dex later). We maintain estimates and our Neutral rating.
Velcade + dex shows higher response rate than VAD
Preliminary data was available for 165 of the 420 enrolled patients in the phase III
IFM study. The combination of Velcade/dex showed a CR/nCR rate (complete
response/near complete response) of 20% compared to 9% for VAD, consistent
with prior phase II data. No p-values were provided as it is only preliminary interim
data and it is not known whether the response rate remains higher for the
Velcade/dex patients after their transplant.
IFM phase IIl study part of plan for Velcade in front-line MM
Millennium may file a supplemental new drug application (sNDA) in 2007 based
on the IFM phase III trial. Other front-line multiple myeloma efforts for Velcade
include the HOV phase III trial (800 transplant patients), initiated in June ’05,
which is studying Velcade/adriamycin/dex vs. VAD, and the VISTA phase III trial
(680 non-transplant patients), initiated in 1Q05, which is studying
Velcade/melphalan/prednisone (VMP) vs MP.
Competition from oral regimens, No change to estimates
The early IFM phase III data showed higher response rates for Velcade/dex
compared to VAD, but the combination would be competing with the established
all oral regimens of Thalomid/dex, and later Revlimid/dex, which have also shown
superior response rates compared to VAD. Our model, however, already
assumes Velcade usage in the front-line multiple myeloma setting and thus we
leave our estimates unchanged.
Maintain Neutral
Our Velcade model already assumes usage in mantle cell lymphoma (label
expansion approved Dec. 9) and in the front-line multiple myeloma setting. With
increasing competition for Velcade, we look for Millennium to continue exploring
ways to increase revenue through potential collaborative and acquisitive activities. |
