Kidney Cancer Journal 75
MEDICAL INTELLIGENCE
Newsworthy, late-breaking information from Web-based
sources, professional societies, and government agencies
JAVELIN Renal 101 Update: Bavencio® (avelumab)
plus Inlyta® (axitinib) significantly improved PFS in
previously untreated patients with advanced RCC
DARMSTADT, GERMANY—Positive top-line results have
been announced from the pivotal Phase III JAVELIN Renal
101 study evaluating bavencio® (avelumab) in combination
with inlyta® (axitinib), compared with Sutent® (sunitinib) as
initial therapy for patients with advanced renal cell carcinoma
(RCC). As part of a planned interim analysis, an independent
data monitoring committee confirmed that the
trial showed a statistically significant improvement in progression
free survival (PFS) by central review for patients
treated with the combination whose tumors had programmed
death ligand-1positive (PD-L1+) expression
greater than 1% (primary objective), as well as in the entire
study population regardless of PD-L1 tumor expression
(secondary objective).
According to the statistical analysis plan, if PFS was statistically
significant in the PD-L1+ subgroup, then PFS in
the entire study population was to be analyzed for statistical
significance. JAVELIN Renal 101 will continue as
planned to the final analysis for the other primary endpoint
of overall survival (OS). No new safety signals were
observed, and adverse events for Bavencio, Inlyta and Sutent
in this trial were consistent with known safety profiles
for all three medicines. The alliance of Merck and Pfizer intends
to pursue a regulatory submission in the US based
on these interim results, and these results will be discussed
with global health authorities. A detailed analysis will also
be submitted for presentation at an upcoming medical
congress.
In December 2017, the US Food and Drug Administration
(FDA) granted Breakthrough Therapy Designation for
Bavencio in combination with Inlyta for treatment-naïve
patients with advanced RCC. Despite available therapies,
the outlook for patients with advanced RCC remains poor.
Approximately 20% to 30% of patients are first diagnosed
at the metastatic stage. The five-year survival rate for patients
with metastatic RCC is approximately 12%.
JAVELIN Renal 101 is a global Phase III, multicenter, randomized
(1:1) study investigating the efficacy and safety of
Bavencio in combination with Inlyta as a first-line treatment
option compared with Sutent monotherapy in 886
patients with advanced RCC across all risk groups. The primary
objectives are to demonstrate that the combination
is superior to Sutent monotherapy in prolonging PFS or OS
in patients with PD-L1+ tumors. Bavencio was administered
at 10 mg/kg IV every two weeks in combination with
Inlyta at 5 mg orally twice daily; Sutent was administered
at 50 mg orally once daily, four weeks on/two weeks off.
IKCS to be held in Miami, November 2-3
MIAMI—The 17th International Kidney Cancer Symposium,
offering a comprehensive agenda and a broad spectrum of
topics on diagnosis and treatment of renal cell carcinoma
will be held at the National Doral Miami Hotel, November
2-3. The symposium, with an expected attendance of 400,
is sponsored by the Kidney Cancer Association. It will present
analyses of emerging trends in RCC, Q&A sessions with
key opinion leaders, and translational findings from clinical
trials. Registration is available through the Kidney Cancer
Association website: https://registeruo.niu.edu/iebms/reg/
reg_p1_form.aspx?oc=40&ct=OTH&eventid=16044
Tivozanib hits another milestone with
approval in Europe for advanced RCC
The European Commission (EC) has approved tivozanib
(Fotivda) for the treatment of patients with advanced renal
cell carcinoma (RCC), according to Aveo, the manufacturer
of the pan-inhibitor of VEGF receptors, and its partner
EUSA Pharma. The drug is specifically approved for the
frontline treatment of adult patients with advanced RCC
and for adults with advanced RCC who are VEGFR- and
mTOR-inhibitor naïve following disease progression after
one prior treatment with cytokine therapy.
The approval, which follows a positive recommendation
from the European Medicines Agency’s Committee for
Medicinal Products for Human Use, is based on the phase
III TiVO-1 trial, in which tivozanib reduced the risk of disease
progression or death by over 20% versus sorafenib
(Nexavar) in patients with advanced RCC who received up
to one prior line of therapy (excluding targeted agents).
Researchers at Institut Gustave Roussy are currently evaluating
tivozanib in combination with nivolumab (Opdivo)
for patients with advanced RCC in the phase I/II dose escalation/
expansion TiNivo trial. Additionally, results are antic-
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