- Subgroup analyses of three
pivotal Phase III MONALEESA trials showed Kisqali plus endocrine
therapy extended PFS in all patients with and without visceral
involvement compared to endocrine therapy alone; consistent with
the overall study populations[3]
-
In patients with visceral
metastasis, increased PFS benefit was seen regardless of burden of
disease (=< 3 or > 3 lesions)[3]
-
Approximately 41% of
postmenopausal women with HR+ advanced breast cancer will develop
their first metastasis in visceral organs, such as the lungs or
liver, which is often associated with a poor prognosis[1],[2]
Basel, December 8, 2018
- Novartis today announced data from subgroup
analyses of the three pivotal Phase III MONALEESA trials showing
that Kisqali® (ribociclib)
plus endocrine therapy extended progression-free survival (PFS)
compared to endocrine therapy alone, regardless of the presence of
visceral metastases in pre-, peri- and postmenopausal women with
hormone receptor positive, human epidermal growth factor receptor-2
negative (HR+/HER2-) advanced breast cancer[1]. These data will be
presented today at the San Antonio Breast Cancer Symposium (SABCS)
(Abstract #P6-18-07).
"Nearly 60% of patients enrolled in the MONALEESA
clinical trials had visceral metastases, and all benefited from
treatment with ribociclib in combination with endocrine therapy,"
said Denise Yardley, MD, Principal Investigator, Sarah Cannon
Research Institute. "These results, coupled with the NCCN and ABC4
recommended treatment guidelines for HR+ advanced breast cancer
patients with visceral metastases, support the use of ribociclib
combination therapy as a standard of care in this patient
population."
In patients with visceral metastases, Kisqali plus
endocrine therapy extended median PFS by 11.5 months in MONALEESA-2
(24.9 months vs 13.4 months) and 13.4 months in MONALEESA-7 (23.8
months vs 10.4 months) compared to endocrine therapy alone. Median
PFS for patients with visceral metastases in the MONALEESA-3 trial
still has not been reached compared to 16.5 months median PFS in
patients receiving endocrine therapy alone.
Kisqali plus endocrine therapy demonstrated
consistent efficacy across the MONALEESA trials in patients with
and without visceral metastases. In patients with visceral
metastases and measurable disease, the overall response rate (ORR)
in patients who received Kisqali plus endocrine therapy compared to
endocrine therapy alone was 53% vs 40% (MONALEESA-2), 50% vs 38%
(MONALEESA-7) and 48% vs 31% (MONALEESA-3). Patients without
visceral disease showed an ORR of 59% vs 35%, 52% vs 32% and 49% vs
39% in the respective MONALEEA-2, MONALEESA-7 and MONALEESA-3
trials[3].
"Patients living with HR+/HER2- advanced breast
cancer who have visceral metastases often have a poorer prognosis
and are at higher risk for treatment resistance and disease
progression than those without," said Samit Hirawat, MD, Head,
Novartis Oncology Global Drug Development. "These sub analyses
reaffirm that it is critical to treat HR+ advanced breast cancer
with a CDK4/6 combination therapy, such as Kisqali plus fulvestrant
or an aromatase inhibitor, to give all patients, especially those
with visceral metastases, the strongest option for delaying disease
progression."
Adverse events for patients with visceral
metastases were consistent with those observed in the overall study
populations and generally manageable through dose interruptions or
reductions.
About Kisqali® (ribociclib)
Kisqali® (ribociclib)
is the CDK4/6 inhibitor with the largest body of first-line
clinical trial evidence demonstrating consistent, superior and
sustained efficacy compared to endocrine therapy alone[4].
Kisqali is a selective cyclin-dependent kinase
inhibitor, a class of drugs that help slow the progression of
cancer by inhibiting two proteins called cyclin-dependent kinase 4
and 6 (CDK4/6). These proteins, when over-activated, can enable
cancer cells to grow and divide too quickly. Targeting CDK4/6 with
enhanced precision may play a role in ensuring that cancer cells do
not continue to replicate uncontrollably[4].
Kisqali was initially approved by the US Food and
Drug Administration (FDA) in March 2017 and by the European
Commission in August 2017, as initial endocrine-based therapy for
postmenopausal women with HR+/HER2- locally advanced or metastatic
breast cancer in combination with an aromatase inhibitor based on
findings from the pivotal MONALEESA-2 trial. In July 2018, Kisqali
was approved by the FDA for the treatment of pre-, peri- or
postmenopausal women in the US, and indicated for use in
combination with fulvestrant as both first- or second-line therapy
in postmenopausal women. In November 2018, the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) adopted a positive opinion recommending an expanded
indication for Kisqali based on the MONALEESA-3 and MONALEESA-7
data. Regulatory filings are underway with other health authorities
worldwide[4].
Kisqali is approved for use in more than 70
countries around the world, including the United States and
European Union member states. Kisqali is not currently approved for
use in combination with fulvestrant or in premenopausal women in
Europe. Kisqali was developed by the Novartis Institutes for
BioMedical Research (NIBR) under a research collaboration with
Astex Pharmaceuticals[4].
Novartis is continuing to reimagine cancer by
investigating Kisqali in early breast cancer (EBC). The NATALEE
study is a Phase III clinical trial of Kisqali with endocrine
therapy in the adjuvant treatment of HR+/HER2- EBC being conducted
in collaboration with Translational Research In Oncology
(TRIO)[4].
About Novartis in Advanced Breast
Cancer
For more than 30 years, Novartis has been tackling breast cancer
with superior science, great collaboration and a passion for
transforming patient care. With one of the most diverse breast
cancer pipelines and one of the largest numbers of breast cancer
compounds in development, Novartis leads the industry in discovery
of new therapies and combinations, especially in HR+ advanced
breast cancer, the most common form of the disease.
Important Safety Information FROM
THE KISQALI EU SmPC
KISQALI® (ribociclib)
is a prescription medicine approved in combination with an
aromatase inhibitor as initial endocrine - based therapy in women
with hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative advanced or metastatic breast cancer or
fulvestrant as initial endocrine - based therapy or following
disease progression on endocrine therapy in postmenopausal women
with hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative advanced or metastatic breast cancer. It
is not known if KISQALI is safe and effective in children or
adolescents. KISQALI can cause a heart problem known as QT
prolongation. This condition can cause an abnormal heartbeat and
may lead to death. KISQALI is not indicated for concomitant use
with tamoxifen due to an increased risk of QT prolongation.
Patients should tell their health care provider right away if they
have a change in their heartbeat (a fast or irregular heartbeat),
or if they feel dizzy or faint. KISQALI can cause serious liver
problems. Patients should tell their health care provider right
away if they get any of the following signs and symptoms of liver
problems: yellowing of the skin or the whites of the eyes
(jaundice), dark or brown (tea-colored) urine, feeling very tired,
loss of appetite, pain on the upper right side of the stomach area
(abdomen), and bleeding or bruising more easily than normal. Low
white blood cell counts are very common when taking KISQALI and may
result in infections that may be severe. Patients should tell their
health care provider right away if they have signs and symptoms of
low white blood cell counts or infections such as fever and chills.
Before taking KISQALI, patients should tell their health care
provider if they are pregnant, or plan to become pregnant as
KISQALI can harm an unborn baby. Females who are able to become
pregnant and who take KISQALI should use highly effective birth
control during treatment and for at least 3 weeks after the last
dose of KISQALI. Do not breastfeed during treatment with KISQALI
and for at least 3 weeks after the last dose of KISQALI. Patients
should tell their health care provider about all of the medicines
they take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements since they may interact with
KISQALI. Patients should avoid grapefruit or grapefruit juice while
taking KISQALI. The most common side effects
(incidence >=20%) include infections, white blood cell
count decreases, headache, cough, nausea, tiredness, diarrhea,
vomiting, constipation, hair loss and rash. The most common Grade
3/4 side effects (incidence >5%) were infections, low
neutrophils, low leukocytes, low red blood cells, abnormal liver
function tests, low lymphocytes, low phosphate levels and vomiting.
Abnormalities were observed in hematology and clinical chemistry
laboratory tests.
Please see full Prescribing Information for
KISQALI, available at www.kisqali.com.
Disclaimer
This press release contains forward-looking statements within the
meaning of the United States Private Securities Litigation Reform
Act of 1995. Forward-looking statements can generally be identified
by words such as "potential," "can," "will," "plan," "expect,"
"anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by
express or implied discussions regarding potential marketing
approvals, new indications or labeling for the investigational or
approved products described in this press release, or regarding
potential future revenues from such products. You should not place
undue reliance on these statements. Such forward-looking statements
are based on our current beliefs and expectations regarding future
events, and are subject to significant known and unknown risks and
uncertainties. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that the
investigational or approved products described in this press
release will be submitted or approved for sale or for any
additional indications or labeling in any market, or at any
particular time. Nor can there be any guarantee that such products
will be commercially successful in the future. In particular, our
expectations regarding such products could be affected by, among
other things, the uncertainties inherent in research and
development, including clinical trial results and additional
analysis of existing clinical data; regulatory actions or delays or
government regulation generally; global trends toward health care
cost containment, including government, payor and general public
pricing and reimbursement pressures; our ability to obtain or
maintain proprietary intellectual property protection; the
particular prescribing preferences of physicians and patients;
general political and economic conditions; safety, quality or
manufacturing issues; potential or actual data security and data
privacy breaches, or disruptions of our information technology
systems, and other risks and factors referred to in Novartis AG's
current Form 20-F on file with the US Securities and Exchange
Commission. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press
release as a result of new information, future events or
otherwise.
About Novartis
Novartis is reimagining medicine to improve and extend people's
lives. As a leading global medicines company, we use innovative
science and digital technologies to create transformative
treatments in areas of great medical need. In our quest to find new
medicines, we consistently rank among the world's top companies
investing in research and development. Novartis products reach
nearly 1 billion people globally and we are finding innovative ways
to expand access to our latest treatments. About 125 000 people of
more than 140 nationalities work at Novartis around the world. Find
out more at www.novartis.com.
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References
[1] National Cancer
Institute. Dictionary of Cancer Terms. Available at:
https://www.cancer.gov/publications/dictionaries/cancer-terms/def/visceral.
Accessed November 2018.
[2] Harb, WA.
Management of patients with hormone receptor-positive breast cancer
with visceral disease: challenges and treatment options. Cancer
Manag Res. 2015;7:37-46.
[3] Yardley D, Chan
A, Nusch, A et al. Ribociclib + endocrine therapy in patients with
hormone receptor-positive, HER2-negative advanced breast cancer
presenting with visceral metastases: Subgroup analysis of Phase III
MONALEESA trials. Presented at the San Antonio Breast Cancer
Symposium (SABCS) (Abstract #P6-18-07) on December 8,
2018.
[4] Novartis Data
on File.
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