Kidney cancer drugs:

Sometimes kidney cancer is called by
its medical name, renal cell carcinoma.
Kidney cancer includes various forms,
including clear cell, papillary,
sarcomatoid, transitional cell, and
Renal cell carcinoma is a type of
kidney cancer in which the cancerous
cells are found in the lining of very
small tubes (tubules) in the kidney.

Tivozanib (not approved yet), Nexavar
and Pfizer's Sutent are all oral drugs
that turn off the same signaling
pathway cancers use to grow.

In December 2011 the Oncologic
Drugs Advisory Committee of the FDA  
voted unanimously to add axitinib
(Inlyta, Pfizer) to the current
armamentarium of approved drugs to
treat patients with advanced renal cell
carcinoma (RCC).

In the phase 3 Axis trial 723 patients
with clear cell advanced RCC in whom
prior treatment had failed were
randomly assigned to axitinib (Inlyta), 5
mg twice daily, or to sorafenib
(Nexavar, Bayer HealthCare), 400 mg
twice daily.

The results showed that axitinib
extended progression-free survival by
2 months over that achieved with
sorafenib. The objective response rate
 with axitinib was also superior, at
19.4%, compared with  9.4% with

The panel took special note of the fact
that the toxicity profiles of the 2 drugs
were dissimilar. Adverse effects with
axitinib included gastrointestinal
adverse events, fatigue, asthenia,
hypertension, dysphonia, and
hypothyroidism. Adverse effects with
sorafenib were severe rash, hand-foot
syndrome, alopecia, and anemia.
The different toxicity profile  is
important for those patients who don't
tolerate sorafenib.

Tuan Ha-Ngoc, the president and CEO
of Aveo Pharmaceuticals, is leading a
very smart charge to advance
tivozanib to the market for kidney
cancers called advanced renal cell
carcinoma (RCC).

In January 2012 an experimental drug
from Aveo Pharmaceuticals delayed
tumor growth in patients with advanced
kidney cancer more effectively than
Onyx Pharmaceuticals' currently
approved drug Nexavar, according to
results from a late-stage study.

The phase III study, dubbed TIVO-1,
was  pitted the experimental tivozanib
head-to-head against Onyx's Nexavar.
Testing an experimental drug against
an active comparator rather than a
placebo can be a risky proposition, but
for Aveo, the bet paid off.

Treatment with tivozanib delayed the
progression of cancer by a median of
11.9 months compared to a median
9.1 months for Nexavar. Both
numerically and statistically, the results
from TIVO-1 demonstrated that
tivozanib was superior to Nexavar,
Aveo said. The study enrolled 517
patients with advanced kidney cancer.
In June 2010, the company showed
results from a Phase II study of a the
drug--a potent blocker of all three
vascular endothelial growth factor
(VEGF) receptors, which play a role in
the formation of blood vessels that
feed tumors--that patients taking the
drug on average lived without their
cancer getting worse for 11.8 months.
That same key indicator of
effectiveness was nearly 14.8 months
among patients with a clear cell form of
RCC who had prior surgeries to
remove at least part of their kidneys.

Pfizer has a  similar drug, axitinib.

Aveo is sharing equally North
American and European development
costs and profits related to tivozanib
with Japan's Astellas Pharma.

Afinitor by Novartis;
Everolimus (Afinitor) may stop the
growth of tumor cells by blocking some
of the enzymes needed for cell growth
or by blocking blood flow to the tumor.

A phase III trial is studying everolimus
to see how well it works in treating
patients with kidney cancer who have
undergone surgery.
Trial no: NCT01120249