Press Release: Novartis Kisqali significantly extends life in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial

Novartis International AG / Novartis Kisqali significantly extends life

in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial.

Processed and transmitted by West Corporation. The issuer is solely

responsible for the content of this announcement.

-- Kisqali is the only CDK4/6 inhibitor to show superior overall survival in

advanced breast cancer (HR=0.712; p=0.00973)[1]

-- After a median of 42 months follow-up, the survival rate was 70.2% for

women who received Kisqali combination therapy compared to 46.0% for

women who received endocrine therapy alone[1]

-- Advanced breast cancer in premenopausal women is the leading cause of

cancer death in women 20-59 years old[2],[3]

-- MONALEESA-7 overall survival results will be presented as a late-breaker

at the 2019 ASCO Annual Meeting and will be published in The New England

Journal of Medicine

The digital press release with multimedia content can be accessed here:

https://novartis.gcs-web.com/Novartis-Kisqali-significantly-extends-life-in-women-with-HR-HER2-advanced-breast-cancer-in-MONALEESA-7-trial

Basel, June 1, 2019 - Novartis today announced statistically significant

overall survival (OS) results for Kisqali in combination with endocrine

therapy[1]. The Phase 3 MONALEESA-7 trial evaluated Kisqali plus

endocrine therapy (goserelin plus either an aromatase inhibitor or

tamoxifen) as initial treatment compared to endocrine therapy alone in

pre- and perimenopausal women with hormone receptor positive, human

epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or

metastatic breast cancer[1]. MONALEESA-7 overall survival results will

be featured in a press briefing today, presented as a late-breaker at

the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting

(Abstract# LBA1008), and will be published in The New England Journal of

Medicine.

The significant extension in survival met the early efficacy stopping

criteria at a pre-specified interim analysis following 192 deaths

(median OS, not reached vs. 40.9 [95% CI: 37.8-NE] months; HR=0.712

[0.535-0.948]; p=0.00973). Overall survival rates in the intent-to-treat

population (n=672) at 42 months were 70.2% for Kisqali combination

therapy compared to 46.0% for endocrine therapy alone. At the time of

data cut-off, 35% of women taking Kisqali combination therapy were

continuing the treatment. No new safety signals were observed[1].

Kisqali is not indicated for use with tamoxifen.

"Overall survival benefit is considered the 'gold standard' in cancer

trials but is challenging to achieve in HR+/HER2- metastatic breast

cancer. MONALEESA-7 reached this important endpoint earlier than

anticipated," said Sara Hurvitz, MD, Medical Director of the Jonsson

Comprehensive Cancer Center Clinical Research Unit and Director of the

Breast Cancer Clinical Trials Program at UCLA. "Impactful results like

these ribociclib findings are what we wish for in every clinical trial,

and to achieve overall survival improvement in an incurable disease,

like metastatic breast cancer, is truly an outstanding advancement for

patients."

Susanne Schaffert, Ph.D., CEO, Novartis Oncology, added, "Kisqali is the

only CDK4/6 inhibitor to achieve statistically significant overall

survival benefit in combination with endocrine therapy, and we are so

proud to share these powerful data with the medical and patient

community. These exciting results add to the proven efficacy and safety

profile of Kisqali, solidify it as a standard of care for people living

with HR+/HER2- metastatic breast cancer and inspire us to continue to

reimagine medicine."

Results from subgroup analyses showed that Kisqali plus an aromatase

inhibitor demonstrated a 30.0% reduced risk of death compared to an

aromatase inhibitor alone (median OS not reached vs. 40.7 months

[37.4-NE]; HR=0.699 [0.501-0.976]), and Kisqali plus tamoxifen

demonstrated a 20.9% reduced risk of death compared to tamoxifen alone

(HR=0.791 [0.454-1.377])[1]. Kisqali is not indicated for use with

tamoxifen. In the MONALEESA-7 primary analysis, increase in QTcF was on

average greater and equal to 10 milliseconds in people taking tamoxifen

plus placebo compared those taking aromatase inhibitor and placebo[4].

"Kisqali has characteristics that make it distinct from other CDK4/6

inhibitors. For one, Kisqali shows especially strong inhibition against

CDK4. In pre-clinical data, Kisqali is four- to five-fold more potent

against CDK4 compared to CDK6. CDK4 is likely the dominant CDK in breast

cancer and a pivotal driver of disease progression," said Jeff Engelman,

MD, Global Head of Oncology Research, Novartis Institutes for BioMedical

Research.

MJ DeCoteau, Executive Director of Rethink Breast Cancer, said, "Younger

women living with advanced breast cancer encounter unique challenges as

they face an incurable illness at the prime of their lives - they may be

students, new moms or just embarking on their careers. Breast cancer is

the leading cause of cancer death in women 20-59, so knowing an approved

treatment has been proven to help them live longer is an outstanding

advancement and provides new hope for women with this devastating

disease."

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[5]. Kisqali is

the only targeted therapy, including CDK4/6 inhibitors, in combination

with endocrine therapy to demonstrate significantly longer overall

survival compared to endocrine therapy alone as initial endocrine-based

treatment for advanced breast cancer in the MONALEESA-7 trial[5].

Overall survival follow-up is ongoing for the Phase III MONALEESA-2 and

MONALEESA-3 trials.

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)[5].

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[5].

Kisqali was developed by the Novartis Institutes for BioMedical Research

(NIBR) under a research collaboration with Astex Pharmaceuticals[5].

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

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June 01, 2019 07:30 ET (11:30 GMT)