Continue the fi ght with INLYTA
Proven effi cacy with a distinct safety profi le
The ONLY approved treatment option to demonstrate
Signifi cant and superior PFS vs a VEGFR-TKI in a phase 3 trial for 2nd-line mRCC*
* Based on MEDLINE® literature review for phase 3 trials in mRCC as of November 2016.
Primary endpoint: progression-free survival (PFS)
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
MONTHS
with INLYTA (n=361)
MONTHS
with sorafenib (n=362)
A distinct safety profi le
All rights reserved. November 2016
Data are from a multicenter, open-label, phase 3 trial
of 723 patients with mRCC after failure of 1st-line
therapy (sunitinib-, temsirolimus-, bevacizumab-, or
cytokine- containing regimen 54%, 3%, 8%, and 35%
of patients in each of the treatment arms, respectively).
Patients were randomized 1:1 to either INLYTA 5 mg
twice daily (n=361) or sorafenib 400 mg twice daily
(n=362), with dose adjustments allowed in both groups.
Primary endpoint was PFS. Secondary endpoints
included objective response rate, overall survival, and
safety and tolerability.1
†IMS® MIDASTM, July 2016.
Monitor for proteinuria before initiation of, and periodically
throughout, treatment. For moderate to severe proteinuria, reduce
the dose or temporarily interrupt treatment.
Liver enzyme elevation has been observed during treatment with
INLYTA. Monitor ALT, AST, and bilirubin before initiation of, and periodically
throughout, treatment.
For patients with moderate hepatic impairment, the starting dose
should be decreased. INLYTA has not been studied in patients with
severe hepatic impairment.
Women of childbearing potential should be advised of potential hazard to
the fetus and to avoid becoming pregnant while receiving INLYTA.
Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the dose.
Grapefruit or grapefruit juice may also increase INLYTA plasma
concentrations and should be avoided.
Avoid strong CYP3A4/5 inducers and, if possible, avoid moderate
CYP3A4/5 inducers.
The most common (≥20%) adverse events (AEs) occurring in patients
receiving INLYTA (all grades, vs sorafenib) were diarrhea (55% vs 53%),
hypertension (40% vs 29%), fatigue (39% vs 32%), decreased appetite
(34% vs 29%), nausea (32% vs 22%), dysphonia (31% vs 14%), handfoot
syndrome (27% vs 51%), weight decreased (25% vs 21%), vomiting
(24% vs 17%), asthenia (21% vs 14%), and constipation (20% vs 20%).
The most common (≥10%) grade 3/4 AEs occurring in patients
receiving INLYTA (vs sorafenib) were hypertension (16% vs 11%),
diarrhea (11% vs 7%), and fatigue (11% vs 5%).
The most common (≥20%) lab abnormalities occurring in patients
receiving INLYTA (all grades, vs sorafenib) included increased
creatinine (55% vs 41%), decreased bicarbonate (44% vs 43%),
hypocalcemia (39% vs 59%), decreased hemoglobin (35% vs 52%),
decreased lymphocytes (absolute) (33% vs 36%), increased ALP
(30% vs 34%), hyperglycemia (28% vs 23%), increased lipase (27%
vs 46%), increased amylase (25% vs 33%), increased ALT (22% vs
22%), and increased AST (20% vs 25%).
Please see Brief Summary on the following pages.
Proportion progression-free
0 2 4 6 8 10 12 14 16 18 20
0.0
HR=0.67 (95% CI: 0.54, 0.81); P<.0001
Time (months)
33% REDUCTION IN
RISK OF PROGRESSION
Over 4 years of clinical experience 49,000 patients treated worldwide† 7 clinical studies reported in
a long-term safety analysis2