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Velcade in a trans plant set ting: Phase III ran dom ized study of vincristine, adriamycin, dexa meth a sone
ver sus Velcade, adriamycin and dexa meth a sone as an in duc tion ther apy and Velcade main te nance in the
trans plant setting.
Velcade plus SGN 40: In June 2008 Se at tle Ge net ics/Genentech (USA) ini ti ated a phase Ib trial of SGN
40 plus Velcade in pa tients with re lapsed or re frac tory MM.
In Sep tem ber 2008, Mil len nium re ported that there are also a num ber of on go ing phase I and II tri als
with Velcade as a sin gle agent or in com bi na tion with other chemotherapeutic agents as a po ten tial treat -
ment for hematologic ma lig nan cies in clud ing non-Hodg kin’s lym phoma and Waldenstrom’s
macroglobulinemia, and var i ous solid tu mors in clud ing lung, breast, pros tate and ovarian cancers.
In Au gust 2006, the FDA granted Mil len nium a pri or ity re view des ig na tion for Velcade for the treat ment of
re lapsed man tle cell lym phoma, an ag gres sive, in cur able sub type of NHL, for which there is cur rently no
standard of care.
In terim anal y sis of a phase III, ran dom ized, open-la bel study of 646 pa tients with re lapsed or re frac tory
MM showed that the com bi na tion of J&J’s Doxil (doxorubicin) and Velcade pro vided a nearly three month
im prove ment in time to dis ease pro gres sion, ver sus Velcade alone. The data was pre sented in De cem ber
2006 at the meet ing of the Amer i can So ci ety of He ma tol ogy. The study re sults dem on strate that pa tients
who re ceived Doxil/Velcade had 45% less risk of their dis ease pro gress ing and a sta tis ti cally sig nif i cant
im prove ment in me dian time to dis ease pro gres sion. The pat terns of ad verse events were con sis tent with
the known tox ic i ties of Doxil and Velcade. There was an in crease in clin i cally rel e vant treat ment-re lated
ad verse events as so ci ated with the com bi na tion of Doxil plus Velcade, mostly due to in creased
hematologic ad verse events such as ane mia (low red blood cell count), neutropenia (low white blood cell
count), thrombocytopenia (low platelet count), and gas tro in tes ti nal ad verse events (such as con sti pa -
tion, di ar rhea, nau sea and vom it ing). The in ci dences of se ri ous ad verse events (36% and 31% for the
Doxil/Velcade and Velcade groups, re spec tively) and ad verse events with out come of death (4% and
3%, re spec tively) tended to be sim i lar be tween the two treat ment groups. The in ci dences of
thromboembolic events (blood clots) were 1% for both the com bi na tion and for Velcade monotherapy.
16% of pa tients ran dom ized to the com bi na tion ex pe ri enced hand-foot syn drome, whereas none of the
pa tients re ceiv ing Velcade monotherapy ex pe ri enced this side ef fect. In Jan u ary 2007, J&J filed an sNDA
for Doxil as com bi na tion ther apy with Velcade for injection to treat patients with MM who have received at
least one prior therapy. This was approved in May 2007.
In June 2007, Mil len nium re ported pos i tive data for Velcade for MM pa tients who had re ceived at least
one prior ther apy. Data in cluded re sults from a phase II trial for sub cu ta ne ous ad min is tra tion of Velcade,
which is an op tion be ing eval u ated by Millennium and J&J.
Com pe ti tion: Celgene’s Thalomid (tha lid o mide) is re ported to be the most widely-pre scribed drug for
MM, but is known to cause se ri ous birth de fects if used by women of child bear ing age. Tha lid o mide is an
old drug (first in tro duced in the 1950s) and is used off la bel for a va ri ety of dis eases. Celgene is re ported
to be seek ing for mal ap proval for use in MM, but the FDA has asked for up dated safety in for ma tion be fore
al low ing the drug to be mar keted for treat ing newly-di ag nosed MM. How ever, in March 2006, it was re -
ported that tha lid o mide failed in a study to pro long the lives of pa tients with MM. In June 2006, up dated
clin i cal data from an on go ing multi-cen tered, ran dom ized, pla cebo-con trolled phase III study of oral
com bi na tion ther apy tha lid o mide plus dexa meth a sone ver sus dexa meth a sone alone as in duc tion ther -
apy for pre vi ously un treated MM sug gested that the com bi na tion of tha lid o mide plus dexa meth a sone led
to a sta tis ti cally sig nif i cant im prove ment in median time to disease progression; this was the primary
endpoint of this trial.
Celgene has now de vel oped a suc ces sor drug, the immunomodulator Revlimid (lenalidomide) for the
treat ment of mul ti ple myeloma and MDS. Revlimid in com bi na tion with dexa meth a sone was ap proved
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