Two New drugs have deliver impactful benefit to =
patients=20
with inoperable/metastatic Melanoma: They are Ipilimumab(Yervoy) and=20
PLX4032(Vemurafenib). 1. Both drugs resulted in increase in Overall =
survival=20
of the treated patients versus the control. 2. However,both drugs =
have=20
certain key limitations which I have described below
Analysis
Ipilimumab, is a Monoclonal Antibody against CTL4 =
antigen=20
on the T lymphocytes and causes immune activation in a small =
fraction of=20
patients where it has resulted in tumor regressions, some of which are =
durable.=20
Unfortunately the drug only causes tumor regressions in about 10% of the =
patients, some of which are long lastiing. More than 90% of the patients =
have=20
limited or No benefit from this drug and will still be looking for =
better=20
therapies. All this(limited) benefit comes with heavy duty Costs of over =
$100,000 for a 12 week course of treatment and some serious(sometimes =
life=20
threatening) Adverse events. Is it worth it? It depends on whom you ask =
and who=20
is going to foot the bill. Vemurafenib is a modern day targeted =
therapy for=20
Melanoma and is clearly an attractive drug because it is taken =
orally and=20
it has resulted in high tumor regression rates(about 50% response rate). =
But=20
there are some caveats to this story. The drug is only indicated for use =
for 50% of Melanoma patients whose tumor shows BRAF mutations which =
is the=20
target for Vemurafenib. So if you do some math, only 1 in 4 patients =
with=20
metastatic melanoma will show benefit from this drug. In other words 75% =
of the=20
melanoma patients will have no benefit from the availability and =
use of=20
Vemurafenib. Furthermore the benefit (in these 25% of the patients) is =
in the=20
form of partial tumor regressions which do not last for more =
than 6=20
to 12 months. Once again we need to do some cost benefit analysis here. =
We=20
do need longer follow up to know the exact survival impact of =
Vemufaranib=20
as the current results are limited to 12-18 months of follow of patients =
in the=20
reported (BRIM 3) trial. Overall the news =
about these=20
2 developments in Melanoma therapy are encouraging but we still have a =
long way=20
to go before we can declare victory in curing patients who are victims =
of=20
metastatic melanoma, which currently remains incurable for more=20
than 80%-90% of the patients.
Sewa S. Legha, MD
Analyses are solely the work of the authors and =
have not=20
been edited or endorsed by GLG.
This author consults with leading institutions through GLG
This author consults with leading institutions through GLG
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