NOVARTIS AG CHF0.50(REGD) Novartis Kisqali(R) Delivers Consistently Superior Overall Survival -- Monaleesa-3 Trial Demonstrat...

 
TIDMNOVN 
 
 
   -- In MONALEESA-3, Kisqali plus fulvestrant achieved statistically 
      significant overall survival benefit vs. fulvestrant alone in 
      postmenopausal women (HR=0.724; p=0.00455)[1] 
 
   -- Kisqali is the only CDK4/6 inhibitor to demonstrate positive overall 
      survival in two pivotal Phase III trials -- consistently demonstrating 
      approximately 30% reduction in the risk of death 
 
   -- Overall survival benefit proven with multiple combination partners and 
      the largest number of patients in MONALEESA-3 plus MONALEESA-7 make 
      Kisqali the CDK4/6 inhibitor with unparalleled overall survival evidence 
 
 
   -- MONALEESA-3 data to be presented in ESMO Congress 2019 Presidential 
      Symposium 
 
 
   Basel, September 29, 2019 -- Novartis today announced results from the 
MONALEESA-3 trial, which showed Kisqali(R) (ribociclib) achieved 
statistically significant improvement in overall survival (OS). This is 
the second Phase III trial in which Kisqali combination therapy met the 
secondary endpoint of overall survival at the pre-planned interim 
analysis. MONALEESA-3 evaluated efficacy and safety of Kisqali plus 
fulvestrant in postmenopausal women with hormone-receptor positive, 
human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced 
or metastatic breast cancer. These data will be presented as a 
late-breaker oral presentation in the Presidential Symposium at the 
European Society for Medical Oncology (ESMO) Congress 2019. 
 
   "Seen now in two Phase III trials, ribociclib consistently and 
significantly prolongs life among premenopausal and postmenopausal women, 
and in combination with an aromatase inhibitor and fulvestrant. These 
results arm oncologists with more evidence to make a confident treatment 
choice for their hormone receptor-positive metastatic breast cancer 
patients," said Dennis J. Slamon, MD, Director of Clinical/Translational 
Research, University of California, Los Angeles Jonsson Comprehensive 
Cancer Center. 
 
   Kisqali in combination with fulvestrant met its secondary endpoint of 
overall survival, demonstrating a statistically significant improvement 
in survival with a 28% reduction in risk of death (median OS not reached 
vs. 40.0 months; HR=0.724; 95% CI: 0.568-0.924; p=0.00455). The 
significant extension in survival met the early efficacy stopping 
criteria at a pre-specified interim analysis. At 42 months, estimated 
rates of survival were 58% for Kisqali combination treatment and 46% for 
fulvestrant alone. Results in the first-line and second-line subgroups, 
including in patients who relapsed within 12 months of adjuvant 
treatment, were consistent with the overall MONALEESA-3 patient 
population. 
 
   Median PFS in the first-line was also reached at this analysis and 
demonstrated that Kisqali in combination with fulvestrant has a median 
PFS of 33.6 months compared to 19.2 months in the placebo arm (HR=0.546; 
95% CI: 0.415-0.718). Additionally, the need for chemotherapy was 
delayed in all patients who were prescribed Kisqali plus fulvestrant 
(HR=0.696; 95% CI: 0.551-0.879). 
 
   "The remarkable results from MONALEESA-3 and MONALEESA-7 make Kisqali 
the CDK4/6 inhibitor with consistently superior overall survival," said 
Susanne Schaffert, PhD, President, Novartis Oncology. "In nearly 25 
years, the five-year survival rates in HR+ metastatic breast cancer have 
improved by less than 5%. We are committed to helping give these women 
more life and are reimagining a world where metastatic breast cancer 
becomes a curable disease." 
 
   MONALEESA-3 is the largest trial to evaluate a CDK4/6 inhibitor plus 
fulvestrant as initial therapy in postmenopausal women (N=726). The 
trial included women with no prior endocrine therapy, including those 
diagnosed de novo, women who relapsed within 12 months of adjuvant 
therapy and women who progressed on endocrine therapy for advanced 
disease. The most common grade 3/4 adverse events of special interest 
observed in this analysis in patients who received Kisqali plus 
fulvestrant compared to fulvestrant alone were neutropenia (57.1% vs 
0.8%), hepatobiliary toxicity (13.7% vs 5.8%), QTc prolongation (3.1% vs 
1.2%), respiratory disorders (2.3% vs 3.3%) and interstitial lung 
disease (0.2% vs 0%). 
 
   "Pre-clinical data show that Kisqali is distinct from other CDK4/6 
inhibitors in its ability to more selectively target and inhibit CDK4," 
said Jeff Engelman, MD, PhD Global Head of Oncology Research, Novartis 
Institutes for BioMedical Research. "CDK4 is a major driver of breast 
cancer progression and inhibiting it has been shown to block the growth 
of breast cancer cells." 
 
   There currently remains no cure for advanced breast cancer. Breast 
cancer is the number one cause of cancer death in European women, 
claiming the lives of more than 150,000 women in 2018.[3] 
 
   About Kisqali(R) (ribociclib) 
 
   Kisqali(R) (ribociclib) is the CDK4/6 inhibitor with the largest body of 
first-line clinical trial evidence demonstrating consistent and 
sustained efficacy compared to endocrine therapy alone[1]. Kisqali is 
the only CDK4/6 inhibitor to achieve statistically significant overall 
survival in two Phase III trials with two distinct patient 
populations[1]. Overall survival results from MONALEESA-7 were presented 
at ASCO 2019, demonstrating Kisqali plus endocrine therapy significantly 
extends life in premenopausal women with HR+/HER2- advanced breast 
cancer. Overall survival follow-up is ongoing for the Phase III 
MONALEESA-2 trial. 
 
   Kisqali is approved for use in more than 75 countries around the world, 
including the United States and European Union member states. Kisqali 
was initially approved by the US Food and Drug Administration (FDA) in 
March 2017 and by the European Commission (EC) 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 in combination with an aromatase inhibitor was approved 
for the treatment of pre-, peri- or postmenopausal women as initial 
endocrine based therapy, and also indicated for use in combination with 
fulvestrant as both first- or second-line therapy in postmenopausal 
women by the FDA in July 2018 and by the EC in December 2018. Regulatory 
filings are underway with other health authorities worldwide[1]. 
 
   Novartis is continuing to reimagine cancer by investigating Kisqali in 
early breast cancer. The NATALEE study is a Phase III clinical trial of 
Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- 
early breast cancer being conducted in collaboration with Translational 
Research In Oncology (TRIO)[1]. 
 
   Kisqali was developed by the Novartis Institutes for BioMedical Research 
(NIBR) under a research collaboration with Astex Pharmaceuticals. 
 
   About Novartis in Advanced Breast Cancer 
 
   Novartis tackles breast cancer with superior science, collaboration and 
a passion for transforming patient care. We've taken a bold approach to 
our research by including patient populations often neglected in 
clinical trials, identifying new pathways or mutations that may play a 
role in disease progression and developing therapies that not only 
maintain, but also improve, quality of life for patients. Our priority 
over the past 30 years and today is to deliver treatments proven to 
improve and extend lives for those diagnosed with advanced breast 
cancer. 
 
   Important Safety Information FROM THE Kisqali EU SmPC 
 
   Kisqali(R) (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," 
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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 
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particular, our expectations regarding such products could be affected 
by, among other things, the uncertainties inherent in research and 
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breaches, or disruptions of our information technology systems, and 
other risks and factors referred to in Novartis AG's current Form 330-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 more than 750 million people 
globally and we are finding innovative ways to expand access to our 
latest treatments. About 108,000 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]    Slamon, DJ, et al. Overall survival (OS) results of the Phase III 
MONALEESA-3 trial of postmenopausal patients (pts) with hormone 
receptor--positive (HR+), human epidermal growth factor 2--negative 
(HER2-) advanced breast cancer (ABC) treated with fulvestrant (FUL) +/- 
ribociclib (RIB). Presented at the European Society of Medical Oncology 
(ESMO) Congress, September 29, 2019, Barcelona, Spain (LBA7). 
 
   [2]    Slamon DJ, et al. Ribociclib (RIB) + fulvestrant (FUL) in 
postmenopausal women with hormone receptor-positive (HR+), HER2-negative 
(HER2-) advanced breast cancer (ABC): Results from MONALEESA-3. Journal 
of Clinical Oncology 2018. 
 
   [3]    Ferlay, J, et al. Global Cancer Observatory: Cancer Today. 
International Agency for Research on Cancer. Available at: 
https://gco.iarc.fr/today/home, accessed September 10, 2019. 
 
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September 29, 2019 10:30 ET (14:30 GMT)

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