based data and randomized clinical trials. Initial CN is
likely underutilized, particularly in non-academic centers
where this underuse may contribute to inferior survival
outcomes among patients who present with mRCC. We
believe that it is important for medical oncologists and
urologists (working as a team) to seriously consider CN
for every patient who presents with mRCC. The choice
of the most appropriate treatment options should be
based on guidelines established by groups like the AUA
and EAU and should reflect careful evaluation of risk
stratification. Patients with favorable to intermediate risk
metastatic RCC constitute the group with the greatest
likelihood of benefiting from initial CN.
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of care for earlier lines of therapy.
The Company plans to discuss the updated OS results
with the FDA to identify the appropriate path forward for
tivozanib in RCC in the fourth quarter, and to provide an
update regarding the potential submission of a New Drug
Application for tivozanib in RCC following these discussions.
“These are the first data to demonstrate durable
improvements in this highly refractory advanced kidney
cancer population, including the post-immunotherapy setting,
a predefined subset of the TIVO-3 trial,” said Brian Rini,
MD, Professor of Medicine, Cleveland Clinic Lerner College
of Medicine of Case Western Reserve University, Director,
Cleveland Clinic Genitourinary Cancer Program, and principal
investigator of the TIVO-3 trial. “The TIVO-3 study suggests
the potential for tivozanib to serve as an important
new treatment option for patients with advanced RCC.
I look forward to seeing tivozanib studied further in the
immunotherapy combination setting, and to continuing
to explore its full potential in the evolving RCC treatment
landscape.”
EAU Calls Upfront Immune Checkpoint
Inhibition New Metastatic RCC Standard of Care
Updated guidelines from the European Association of
Urology (EAU) consider immune checkpoint inhibition
with pembrolizumab plus axitinib or ipilimumab plus
nivolumab to be a new standard of care for the first-line
treatment of metastatic clear-cell renal cell carcinoma
(RCC).
According to the guidelines, the EAU recommends that
physicians offer pembrolizumab plus axitinib to treatmentnaïve
patients with any IMDC (International Metastatic
Renal Cell Carcinoma Database Consortium) risk disease
and ipilimumab plus nivolumab to treatment-naïve
patients with IMDC intermediate- and poor-risk disease.
The recommendations are based on clinical trials showing
that these combinations are associated with a survival
benefit in these patients. In the KEYNOTE-426 trial, the
combination of pembrolizumab and axitinib was associated
with a significant 47% decreased risk of death compared
with sunitinib monotherapy. It also was associated
with a significant 31% decreased risk of disease progression.
In the Checkmate 214 trial, the combination of
ipilimumab and nivolumab was associated with a
significant 37% decreased risk of death compared with
sunitinib monotherapy. KCJ
MEDICAL INTELLIGENCE
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