Novartis presents updated data that reinforce the efficacy and safety of Kisqali® (ribociclib) plus letrozole as a first-line option for HR+/HER2- advanced or metastatic breast cancer
(Thomson Reuters ONE) -
Novartis International AG /
Novartis presents updated data that reinforce the efficacy and safety of
Kisqali® (ribociclib) plus letrozole as a first-line option for HR+/HER2-
advanced or metastatic breast cancer
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The issuer is solely responsible for the content of this announcement.
* At a subsequent analysis of the MONALEESA-2 trial, after nearly one year of
additional follow-up, Kisqali plus letrozole demonstrated median
progression-free survival (PFS) of 25.3 months compared to 16.0 months for
letrozole alone[1]
* Patients on Kisqali plus letrozole maintained overall health-related quality
of life compared to those treated with letrozole alone, and no new safety
concerns have been identified[2]
* Novartis continues to evaluate Kisqali in multiple trials, in combination
with different hormonal therapies, across a broad range of patients
Basel, June 2, 2017 - Novartis announced today updated findings from the Phase
III MONALEESA-2 study that reinforce the efficacy and safety of Kisqali(®)
(ribociclib) plus letrozole in postmenopausal women with hormone receptor
positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced
or metastatic breast cancer. After an additional 11 months of follow-up, a
median progression-free survival (PFS) of 25.3 months (95% CI: 23.0-30.3) for
Kisqali plus letrozole and 16.0 months (95% CI: 13.4-18.2) for letrozole alone
was observed (HR=0.568 (95% CI: 0.457-0.704; p<0.0001))[1]. These data will be
presented on Sunday, June 4, 2017 at the 53(rd) Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Chicago (Abstract #1038).
These updated results further support that Kisqali plus letrozole improves PFS
as a first-line treatment across all patient subgroups[1]. After two years of
treatment, the progression-free survival rate was 54.7% in the Kisqali plus
letrozole arm compared to 35.9% in patients treated with letrozole alone[1]. In
a cohort of 213 US patients treated as part of MONALEESA-2, the median PFS was
27.6 months with Kisqali plus letrozole and 15.0 months with letrozole alone
(HR=0.527 (95% CI: 0.351-0.793))[1].
Treatment benefit remained consistent across all patient subgroups regardless of
demographics or disease characteristics, including women with visceral disease
and those diagnosed de novo[1]. In women with measurable disease at baseline,
55% saw their tumor size shrink by at least 30% (overall response rate (ORR))
compared to 39% with letrozole plus placebo[1]. Follow-up to measure overall
survival is ongoing as data remain immature[1].
"This new look at the MONALEESA-2 data, after an additional year of follow-up,
demonstrates the continued efficacy of ribociclib plus letrozole," said Gabriel
N. Hortobagyi, MD, Professor of Medicine, Department of Breast Medical Oncology,
Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
and MONALEESA-2 Principal Investigator. "With more than two years of follow-up,
the PFS data confirm the inclusion of ribociclib plus an aromatase inhibitor as
a strong option among first-line treatments for HR-positive, HER2-negative
advanced breast cancer."
A separate analysis of patient-reported, health-related quality of life (HRQoL)
outcomes from the MONALEESA-2 trial presented at ASCO (Abstract #1020) showed no
significant difference in quality of life for women taking Kisqali plus
letrozole compared to those taking letrozole alone[2]. This suggests that
adverse events did not significantly impact HRQoL[2].
Updated safety data from the MONALEESA-2 trial show the safety profile of
Kisqali plus letrozole remained consistent and the incidence of laboratory and
electrocardiogram (ECG) irregularities is similar to that observed at the first
interim analysis[1]. At the time of this updated analysis, the most common
(>=10%) grade 3/4 laboratory abnormalities were as follows for Kisqali plus
letrozole compared to letrozole alone: decreased neutrophils (62.6% vs 1.5%),
decreased leukocytes (36.8% vs 1.5%), decreased lymphocytes (16.2% vs 3.9%) and
elevated alanine aminotransferase (11.4% vs 1.2%)[1].
"Updated MONALEESA-2 results validate the sustained efficacy and established
safety profile of Kisqali plus letrozole in patients with HR+/HER2- metastatic
breast cancer and confirm the data that supported its recent FDA approval," said
Vas Narasimhan, MD, Head, Global Drug Development and Chief Medical Officer,
Novartis. "We are excited about the potential of Kisqali, and are continuing to
evaluate its activity in several Phase III trials with multiple hormonal therapy
combinations across a broad range of patient populations, including in the
adjuvant setting. We look forward to sharing new results with the scientific
community in the coming months and years."
The MONALEESA clinical trial program includes two additional Phase III trials in
advanced breast cancer, MONALEESA-3 and MONALEESA-7, which are evaluating the
efficacy and safety of Kisqali in combination with other endocrine partners.
Novartis also is enrolling patients in a study to further evaluate Kisqali in
men and pre- or postmenopausal women (CompLEEment-1) and initiating Phase III
trials evaluating Kisqali in the adjuvant therapy setting (EarLEE-1 and EarLEE-
2).
Kisqali was approved by the US Food and Drug Administration (FDA) on March
13, 2017, as a first-line treatment for HR+/HER2- metastatic breast cancer in
combination with any aromatase inhibitor.
Full US prescribing information for Kisqali can be found at
https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/kisqal
i.pdf.
About Kisqali(®) (ribociclib)
Kisqali (ribociclib) 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.
Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR)
under a research collaboration with Astex Pharmaceuticals.
About the Kisqali Clinical Trial Program
MONALEESA-3 is evaluating Kisqali in combination with fulvestrant compared to
fulvestrant alone in postmenopausal women with HR+/HER2- advanced breast cancer
who have received no or a maximum of one prior endocrine therapy. MONALEESA-7 is
investigating Kisqali in combination with endocrine therapy and goserelin
compared to endocrine therapy and goserelin alone in premenopausal women with
HR+/HER2- advanced breast cancer who have not previously received endocrine
therapy. These trials are fully enrolled.
Novartis will initiate two multicenter, randomized, double-blind Phase III
clinical trials, EarLEE-1 and EarLEE-2, to evaluate the safety and efficacy of
Kisqali with endocrine therapy as adjuvant therapy in pre- and postmenopausal
women who have not previously received treatment with CDK4/6. EarLEE-1 will
assess Kisqali with adjuvant endocrine therapy compared to adjuvant endocrine
therapy alone in women with HR+/HER2- high-risk early breast cancer. EarLEE-2
will investigate Kisqali with adjuvant endocrine therapy compared to adjuvant
endocrine therapy alone in women with HR+/HER2- intermediate-risk early breast
cancer.
The CompLEEment study is evaluating the safety and efficacy of Kisqali plus
letrozole in men and pre- or postmenopausal women with HR+/HER2- advanced breast
cancer with no prior hormonal therapy for advanced disease. This open-label,
multicenter, Phase IIIb CompLEEment-1 trial is currently enrolling participants.
More information about these studies can be found at ClinicalTrials.gov.
About Novartis in Advanced Breast Cancer
For more than 25 years, Novartis has been at the forefront of driving scientific
advancements for breast cancer patients and improving clinical practice in
collaboration with the global community. With one of the most diverse breast
cancer pipelines and the largest number 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.
Kisqali(®) (ribociclib) Important US Safety Information
Kisqali(®) (ribociclib) is a prescription medicine used in combination with an
aromatase inhibitor as the first hormonal-based therapy to treat women who have
gone through menopause 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. Kisqali can cause
a heart problem known as QT prolongation. This condition can cause an abnormal
heartbeat and may lead to death. 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 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 pomegranate or
pomegranate juice, and grapefruit or grapefruit juice while taking Kisqali. The
most common side effects (incidence >=20%) of Kisqali when used with letrozole
include white blood cell count decreases, nausea, tiredness, diarrhea, hair
thinning or hair loss, vomiting, constipation, headache, and back pain. The most
common grade 3/4 side effects in the Kisqali + letrozole arm (incidence >2%)
were low neutrophils, low leukocytes, abnormal liver function tests, low
lymphocytes, and vomiting. Abnormalities were observed in hematology and
clinical chemistry laboratory tests.
Please see full US Prescribing Information for Kisqali, available at
www.kisqali.com.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "continues," "recommended," "will," "support," "ongoing,"
"suggests," "excited," "potential," "continuing to evaluate," "look forward,"
"in the coming months and years," "may," "evaluating," "investigating,"
"investigate," "pipelines," "in development," or similar terms, or by express
or implied discussions regarding potential new indications or labeling for
Kisqali or any of the other products in the Novartis breast cancer pipeline,
regarding potential marketing approvals for Kisqali or any of the other products
in the Novartis breast cancer pipeline, or regarding potential future revenues
from Kisqali and the other products in the Novartis breast cancer pipeline. You
should not place undue reliance on these statements. Such forward-looking
statements are based on the current beliefs and expectations of management
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 Kisqali or any of the other products in the
Novartis breast cancer pipeline will be submitted or approved for any additional
indications or labeling in any market, or at any particular time. Neither can
there be any guarantee that Kisqali will be submitted or approved for sale in
any additional markets, or at any particular time. Nor can there be any
guarantee that any of the other products in the Novartis breast cancer pipeline
will be submitted or approved for sale in any market, or at any particular time.
Neither can there be any guarantee that Kisqali or any of the other products in
the Novartis breast cancer pipeline will be commercially successful in the
future. In particular, management's expectations regarding Kisqali and the other
products in the Novartis breast cancer pipeline 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; the company's
ability to obtain or maintain proprietary intellectual property protection;
general economic and industry conditions; global trends toward healthcare cost
containment, including ongoing pricing and reimbursement pressures; safety,
quality or manufacturing issues, 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 provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
118,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Hortobagyi G, Stemmer S, Burris H, et al. Updated results from MONALEESA-2,
a phase III trial of first-line ribociclib plus letrozole in hormone receptor-
positive HER2-negative advanced breast cancer. Presented at the 53rd Annual
Meeting of the American Society of Clinical Oncology (ASCO), June 4, 2017,
Chicago, Illinois (abstract #1038).
[2] Verma S, O'Shaughnessy J, Burris H, et al. Health-related quality of life
(HRQoL) of postmenopausal women with hormone receptor-positive (HR+), human
epidermal growth factor receptor 2-negative (HER20) advanced breast cancer (ABC)
treated with ribociclib + letrozole: Results from MONALEESA-2. Presented at the
53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), June
4, 2017, Chicago, Illinois (abstract #1020).
# # #
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