Press Release: Novartis data demonstrates consistent efficacy and tolerability of Kisqali(R) combination therapy in HR+/HER2- advanced breast cancer in patie...

Novartis International AG / Novartis data demonstrates consistent

efficacy and tolerability of Kisqali(R) combination therapy in HR+/HER2-

advanced breast cancer in patients with difficult-to-treat visceral

disease. Processed and transmitted by West Corporation. The issuer is

solely responsible for the content of this announcement.

-- 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(R) (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(R) (ribociclib)

Kisqali(R) (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(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,"

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December 08, 2018 08:00 ET (13:00 GMT)