Download Afinitor® in HR+ Advanced Breast Cancer

Afinitor® in HR+ Advanced Breast Cancer
How does it work?
• Afinitor® (everolimus) targets the mTOR pathway,
which is hyperactivated in many types of cancer
cells and acts as an important regulator of
tumor cell division, blood vessel growth and cell
metabolism2
• Endocrine therapy remains the cornerstone
of treatment for women with HR+ advanced
breast cancer, but most will eventually develop
treatment resistance2,3
• Therapeutic resistance has been associated with
overactivation of the PI3K/AKT/mTOR pathway2
The approval of Afinitor in HR+ advanced breast
cancer was based on the pivotal Phase III data from
the randomized, double-blind, placebo-controlled,
multi-center BOLERO-2 (Breast cancer trials of OraL
EveROlimus-2) trial1.
• Worldwide a total of 724 women with HR+/HER2negative advanced breast cancer from 195 sites
participated in the trial
• All women received exemestane and were
randomized 2:1 to Afinitor or placebo
• 485 women received Afinitor and exemestane;
239 women received placebo and exemestane
Results of BOLERO-2 1
• Afinitor plus exemestane more than doubled
median progression-free survival (PFS)
›› 7.8 months with Afinitor and exemestane vs
3.2 months with placebo and exemestane
alone (hazard ratio=0.45 [95% CL: 0.38 to 0.54;
p<0.0001) by local investigator assessment
›› 11.0 months with Afinitor and exemestane
vs 4.1 month with placebo and exemestane
alone (hazard ratio=0.38 [95% CI: 0.31 to
0.48]; p<0.0001) by independent central
radiology review
Please see Important Safety Information on reverse.
Afinitor (everolimus)* is approved
in more than 80 countries for the
treatment of hormone receptorpositive (HR+), HER2/neu-negative
(HER2-) advanced breast cancer
(HR+ advanced breast cancer), in
combination with exemestane, in
postmenopausal women without
symptomatic visceral disease after
recurrence or progression following a
non-steroidal aromatase inhibitor1.
• A
finitor is the only mTOR inhibitor
approved to treat advanced
breast cancer
•
A
finitor has been approved in the
European Union since 2009 to treat
various tumors; approximately
150,000 patients have been
treated with Afinitor to date1
Dosing1
The recommended dose of Afinitor for the treatment of
HR+ advanced breast cancer is 10mg, to be taken once
daily at the same time every day, consistently either
with or without food in combination with exemestane.
Adverse Events1
The most common adverse reactions (incidence ≥ 30%)
were stomatitis, infections, rash, fatigue, diarrhea
and decreased appetite. The most common grade 3-4
adverse reactions (incidence ≥ 2%) were stomatitis,
infections, hyperglycemia, fatigue, dyspnea,
pneumonitis and diarrhea.
*Known as Votubia® (everolimus) tablets for certain patients with SEGA associated with TSC in the EU and
Switzerland.
Afinitor ® Important Safety Information
Afinitor/Votubia can cause serious side effects including lung or breathing problems, infections (including
sepsis), and kidney failure, which can lead to death. Mouth ulcers and mouth sores are common side effects.
Afinitor/Votubia can affect blood cell counts, kidney and liver function, and blood sugar, cholesterol, and
triglyceride levels. Afinitor/Votubia may cause fetal harm in pregnant women. Highly effective contraception is
recommended for women of child-bearing potential while receiving Afinitor/Votubia and for up to eight weeks
after ending treatment. Women taking Afinitor/Votubia should not breast feed. Fertility in women and men
may be affected by treatment with Afinitor/Votubia.
The most common adverse drug reactions (incidence ≥10 percent) are mouth ulcers, skin rash, feeling tired or
weak, diarrhea, nausea, decreased appetite, infections (including upper respiratory tract infection, low level
of red blood cells, abnormal taste, inflammation of lung tissue, weight loss, swelling of extremities or other
parts of the body, nose bleeds, itching, vomiting, high level of blood cholesterol, headache, high level of blood
sugar, cough, spontaneous bleeding or bruising, and breathlessness. The most common Grade 3-4 adverse drug
reactions (incidence ≥2 percent) are mouth ulcers, feeling tired or weak, infections, inflammation of lung tissue,
diarrhea, spontaneous bleeding or bruising, low white blood cells (a type of blood cell that fights infection),
and breathlessness. Cases of hepatitis B reactivation, blood clots in the lung or legs, and menstruation disorders
such as absence of periods have been reported. Abnormalities were observed in hematology and clinical
chemistry laboratory tests.
References
1
Novartis Data on File.
2
Baselga, J. Everolimus in Postmenopausal Hormone-Receptor-Positive Advanced Breast Cancer. New England Journal of Medicine. February 9, 2012.
3
Ellis M. Overcoming Endocrine Therapy Resistance by Signal Transduction Inhibition. The Oncologist. April 15, 2004.
©Novartis 2014
Printed in U.S.A.
G-AFI-1084413 3/14