Novartis Kisqali® is first and only CDK4/6 inhibitor to show superior median PFS compared to oral endocrine therapy as first-line treatment in a prospective, randomized Phase III trial dedicated to...|
Novartis International AG /
Novartis Kisqali® is first and only CDK4/6 inhibitor to show superior median PFS
compared to oral endocrine therapy as first-line treatment in a prospective,
randomized Phase III trial dedicated to...
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* Kisqali plus an oral endocrine partner demonstrated significant efficacy
with sustained benefit of nearly two years (median PFS 23.8 vs 13.0 months
for endocrine therapy alone) and an early response with separation of the
PFS curves as early as eight weeks
* MONALEESA-7 evaluated Kisqali in combination with oral hormonal therapies
(tamoxifen or an aromatase inhibitor) and goserelin vs endocrine therapy and
goserelin alone in this patient population
* Kisqali is the only CDK4/6 inhibitor to show efficacy in combination with
tamoxifen (median PFS 22.1 vs 11.0 months); Kisqali plus aromatase inhibitor
demonstrated additional 14 month PFS compared to aromatase inhibitor alone
(median PFS 27.5 vs 13.8 months)
* Women taking Kisqali experienced a clinically meaningful improvement in
pain, as early as eight weeks, that was sustained and maintained their
health-related QoL for a longer time compared to those taking endocrine
* Pending approval in this indication, the clinical benefit demonstrated in
the MONALEESA-7 trial expected to support the use of Kisqali as a standard
of care for premenopausal women with HR+/HER2- advanced breast cancer
Basel, December 6, 2017 - Novartis today announced results from the Phase III
MONALEESA-7 trial in premenopausal or perimenopausal women with hormone-receptor
positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced
or metastatic breast cancer demonstrating Kisqali(® )(ribociclib) in combination
with an aromatase inhibitor or tamoxifen and goserelin as initial endocrine-
based therapy significantly prolonged progression-free survival (PFS) compared
to endocrine therapy and goserelin alone. These data will be presented today
as a late-breaker oral presentation at the 2017 San Antonio Breast Cancer
Symposium (SABCS) (Abstract #S2-05).
Kisqali in combination with tamoxifen or an aromatase inhibitor plus goserelin
demonstrated a median PFS of 23.8 months (95% CI: 19.2 months-not reached)
compared to 13.0 months (95% CI: 11.0-16.4 months) for tamoxifen or an aromatase
inhibitor plus goserelin (HR=0.553; 95% CI: 0.441-0.694; p<0.0001).
Premenopausal women treated with Kisqali combination therapy saw a response as
early as eight weeks as demonstrated by separation of the PFS curves compared to
endocrine therapy alone.
"The strength of the MONALEESA-7 data is impressive and will give oncologists an
important option if ribociclib is approved as treatment for this patient
population as well as greater flexibility in the choice of endocrine therapy
given with this agent," said Dr. Debu Tripathy, chair of Breast Medical
Oncology, The University of Texas MD Anderson Cancer Center. "Women who are
premenopausal at the time of their breast cancer diagnosis tend to have more
aggressive disease with poorer prognosis along with unique needs and
experiences, so it is critical we determine which treatments will be most
effective while also well tolerated."
MONALEESA-7 trial evaluated Kisqali in combination with tamoxifen and an
aromatase inhibitor. This is the only Phase III study to evaluate a CDK4/6
inhibitor in combination with tamoxifen and establishes the safety and efficacy
of Kisqali in this combination as first-line treatment for advanced breast
cancer (median PFS of 22.1 vs 11.0 months; HR=0.585; 95% CI: 0.387-0.884).
Kisqali in combination with an aromatase inhibitor demonstrated an additional
14 months progression-free survival over endocrine therapy alone (median PFS of
27.5 vs 13.8 months; HR=0.569; 95% CI: 0.436-0.743).
Premenopausal women taking Kisqali benefited for a longer time until health-
related quality of life (QoL) deterioration compared to those taking endocrine
therapy alone. Women taking Kisqali also had a clinically meaningful
improvement in pain symptoms as early as eight weeks; this improvement was
No new safety signals were observed in the MONALEESA-7 trial; adverse events
were generally consistent with those observed in MONALEESA-2, identified early
and mostly managed through dose interruptions or reductions. Combination
treatment with Kisqali was well tolerated with a discontinuation rate due to
adverse events of 3.6% compared to 3.0% in patients who received endocrine
therapy alone. The most common (>=5%) grade 3/4 adverse events in patients
receiving Kisqali combination therapy compared to endocrine therapy alone were
neutropenia (60.6% vs 3.6%) and leukopenia (14.3% vs 1.2%).
"We are pleased to see Kisqali combination therapy provide strong efficacy and
prolonged quality of life with pain reduction in younger women, and look forward
to working with health authorities to bring a new treatment option to
premenopausal or perimenopausal women," said Samit Hirawat, MD, Head, Novartis
Oncology Global Drug Development. "Research in premenopausal advanced breast
cancer is extremely limited as these women traditionally have been excluded from
clinical trials or reduced to a subgroup in trials designed for their
postmenopausal counterparts. We designed the robust MONALEESA clinical trial
program to be inclusive of all women and men with HR+/HER2- advanced breast
Premenopausal breast cancer is a biologically distinct and more aggressive
disease than postmenopausal breast cancer, and it is the leading cause of cancer
death in women 20-59 years old,.
Novartis plans to discuss MONALEESA-7 data with global health authorities
MONALEESA-7 is a Phase III randomized, double-blind, placebo-controlled trial
investigating the efficacy and safety of Kisqali in combination with tamoxifen
or a non-steroidal aromatase inhibitor plus goserelin versus tamoxifen or an
aromatase inhibitor plus goserelin, in premenopausal or perimenopausal women
with HR+/HER2- advanced breast cancer who had not previously received endocrine
therapy for advanced disease. More than 670 women ranging from 23-58 years in
age were randomized in the MONALEESA-7 trial. The first patient assessment
occurred at eight weeks; separation of the PFS curves at this time was not a
pre-specified endpoint of the study.
About Kisqali(®) (ribociclib)
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.
Kisqali was approved 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. Kisqali is not currently approved
for use in premenopausal patients.
Kisqali is approved for use in 44 countries around the world, including the
United States and European Union member states. Kisqali was developed by the
Novartis Institutes for BioMedical Research (NIBR) under a research
collaboration with Astex Pharmaceuticals.
About the Kisqali Clinical Trial Program
With more than 2,000 patients, the MONALEESA program is the largest Phase III
clinical program researching use of a CDK4/6 inhibitor in advanced breast
The MONALEESA-7 findings add to the body of evidence from MONALEESA-2 supporting
the benefit of Kisqali plus hormone therapy in first-line treatment of HR+/HER2-
advanced or metastatic breast cancer. Novartis is continuing to evaluate Kisqali
in combination with multiple hormonal therapies across a broad range of
patients, including in the adjuvant setting.
MONALEESA-2 is a Phase III global registration trial evaluating Kisqali in
combination with letrozole compared to letrozole alone in postmenopausal women
with HR+/HER2- advanced breast cancer who received no prior therapy for their
advanced breast cancer.
MONALEESA-3 is a Phase III study evaluating Kisqali in combination with
fulvestrant compared to fulvestrant alone in postmenopausal women or men with
HR+/HER2- advanced breast cancer who have received no or a maximum of one prior
endocrine therapy. MONALEESA-3 is fully enrolled.
CompLEEment-1 is an open-label, multicenter, Phase IIIb study evaluating the
safety and efficacy of Kisqali plus letrozole in men and pre- or postmenopausal
women with HR+/HER2- advanced breast cancer who have not received prior hormonal
therapy for advanced disease. CompLEEment-1 is enrolling.
The safety and efficacy of Kisqali with endocrine therapy as adjuvant therapy in
premenopausal and postmenopausal women who have not previously received
treatment with a CDK4/6 inhibitor is also being evaluated in the EarLEE-1 study,
which is enrolling.
More information about these studies can be found at www.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
Important Safety Information from the Kisqali EU SmPC
The most common ADRs and the most common grade 3/4 ADRs (reported at a frequency
>=20% and >=2% respectively) for which the frequency for Kisqali plus letrozole
exceeds the frequency for placebo plus letrozole were blood and lymphatic system
disorders (including abnormally low neutrophil and white blood cell count),
headache, back pain, nausea, fatigue, diarrhea, vomiting, constipation, hair
loss and rash and abnormally low levels of neutrophils or white blood cells,
abnormal liver function tests (increased alanine and aspartate
aminotransferase), abnormally low lymphocyte count, low levels of phosphate,
vomiting, nausea, fatigue and back pain, respectively. Low levels of neutrophils
was the most commonly seen severe adverse event; fever in addition to a low
neutrophil count was reported in 1.5% of patients.
Kisqali can cause serious side effects such as a significant decrease in
neutrophil count, abnormal liver function tests and may have an effect on the
electrical activity of the heart known as QT/QTc interval prolongation, which
could lead to disturbances in heart rhythm. As a precaution, patients should
have complete blood counts, liver function, and serum electrolyte levels
measured prior to starting treatment as well as during treatment with Kisqali.
Patients should also have their heart activity checked before and monitored
The efficacy and safety of ribociclib have not been studied in patients with
critical visceral disease.
The use of Kisqali with medicinal products known to prolong QTc interval or
strong CYP3A4 inhibitors should be avoided as this may lead to prolongation of
the QT/QTc interval. If treatment with a strong CYP3A4 inhibitor cannot be
avoided, the Kisqali dose should be reduced. Concomitant administration with
other medicines that could affect cardiac repolarization or prolong the QT/QTc
interval should be taken into account prior to and during treatment with
Kisqali. Patients taking sensitive CYP3A4 substrates with narrow therapeutic
index should use caution because of the increased risk of adverse events that
may occur if these medications are co-administered with Kisqali.
Kisqali contains soya lecithin and therefore it should not be taken by patients
who are allergic to peanut or soya.
Animal studies suggest that Kisqali may cause fetal harm in pregnant women.
Therefore, as a precaution, women of childbearing potential should use effective
contraception while receiving Kisqali during treatment and up to 21 days after
stopping treatment. Women should not breast feed for at least 21 days after the
last dose of Kisqali. Kisqali may affect fertility in males.
Please see full Prescribing Information for Kisqali, available at
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 Tripathy D, Sohn J, Im S, et al. First-line ribociclib or placebo combined
with goserelin and tamoxifen or a non-steroidal aromatase inhibitor in
premenopausal women with hormone receptor-positive, HER2-negative advanced
breast cancer: results from the randomized Phase III MONALEESA-7 trial.
Presented at the San Antonio Breast Cancer Symposium (SABCS), December 6, 2017,
San Antonio, Texas (abstract#S2-05).
 Kisqali (ribociclib) Prescribing information. East Hanover, New Jersey, USA:
Novartis Pharmaceuticals Corporation; March 2017.
 Benz CC. Impact of aging on the biology of breast cancer. Crit Rev Oncol
 World Health Organization. Women's health fact sheet. September 2013.
Available at http://www.who.int/mediacentre/factsheets/fs334/en/. Accessed
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