Bli medlem
Bli medlem

Du är här


Novartis International AG: MONALEESA-2 trial of Novartis' LEE011 (ribociclib) stopped due to positive efficacy results at interim analysis in HR+/HER2- advanced

Novartis International AG / MONALEESA-2 trial of Novartis' LEE011 (ribociclib)
stopped due to positiveefficacy results at interim analysis in HR+/HER2-
advanced breast cancer . Processed and transmitted by NASDAQ OMX Corporate
Solutions.The issuer is solely responsible for the content of this
* Independent Data Monitoring Committee recommends stopping the trial early
as it met the primary endpoint, significantly extending progression-free
survival (PFS) compared to letrozole alone, at pre-planned interim
* LEE011 (ribociclib), a CDK4/6 inhibitor, in combination with letrozole,
showed clinically meaningful improvement in PFS in postmenopausal women who
had received no prior therapy for advanced breast cancer[1]
* Full results will be presented at an upcoming medical congress; Novartis
will initiate discussions with regulatory authorities worldwide

Basel, May 18, 2016

Novartis announced today that the MONALEESA-2 independent Data Monitoring
Committee recommended stopping the trial early as results of a pre-planned
interim analysis showed the trial met the primary endpoint of clinically
meaningful improvement in PFS[1]. MONALEESA-2 is a pivotal Phase III trial of
LEE011 (ribociclib), a cyclin dependent kinase inhibitor (CDK4/6), in
combination with letrozole, compared to letrozole alone in postmenopausal
women who had received no prior therapy for their hormone receptor positive,
human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast

"We are excited that these results validate our belief that LEE011 in
combination with letrozole can be a beneficial treatment option for women
diagnosed with HR+/HER2- advanced breast cancer," said Alessandro Riva,
Global Head, Oncology Development and Medical Affairs, Novartis Oncology.
"Novartis is dedicated to continuing to discover and develop innovative
targeted therapies that help improve and extend the lives of women living
with this disease."

As part of the company's ongoing commitment to addressing the needs of
patients living with advanced breast cancer, Novartis will be evaluating
possible expanded access programs in some regions to help ensure women who
may benefit from LEE011 have access to it.

The adverse events observed with LEE011 in combination with letrozole in
MONALEESA-2 were generally consistent with their respective known adverse
event profiles[1].

The MONALEESA-2 trial will continue to assess overall survival data. Detailed
efficacy and safety data will be submitted for presentation at a major
medical congress and Novartis will begin discussions with global health
authorities about regulatory filings.


MONALEESA-2 (MammaryONcologyAssessment ofLEE011'sEfficacy andSAfety-2) is a
Phase III randomized, double blind, placebo controlled, multicenter global
registration trial to evaluate the safety and efficacy of LEE011 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[1].

The trial was conducted at 294 clinical trial sites globally and randomized
668 patients in a 1:1 ratio stratified by the presence of liver and/or lung
metastases[1]. Patients received LEE011 600 mg/daily (three weeks on and one
week off), or placebo, in combination with letrozole 2.5 mg/daily per the
approved label[1].

The primary endpoint of the trial was PFS[1]. Secondary endpoints included:
overall survival, overall response rate, clinical benefit rate,
health-related quality of life, safety and tolerability[1].

About LEE011 (ribociclib)

LEE011 (ribociclib) is a cyclin dependent kinase inhibitor (CDKi), a new 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 in a cell, can enable cancer cells to grow and divide too

LEE011 has been studied in non-clinical models and is currently being
evaluated in combination with additional endocrine agents as part of the
MONALEESA clinical trial program. LEE011 is not approved for any indication
in any market at this time.

The MONALEESA-3 trial is evaluating LEE011 in combination with fulvestrant
compared to fulvestrant alone in men and post-menopausal women with HR+/HER2-
advanced breast cancer who have received no or a maximum of one prior
endocrine therapy. The MONALEESA-7 trial is investigating LEE011 in
combination with endocrine therapy and goserelin compared to endocrine
therapy and goserelin alone in pre-menopausal women with HR+/HER2- advanced
breast cancer who have not previously received endocrine therapy. Both Phase
III programs, MONALEESA-3 and MONALEESA-7 are recruiting patients worldwide.

LEE011 was developed by Novartis Institutes for BioMedical Research (NIBR)
under a research collaboration with Astex Pharmaceuticals.

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 partnership with the global community[1]. 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[1].

About advanced breast cancer

Advanced breast cancer comprises metastatic breast cancer (stage IV) and
locally advanced breast cancer (stage III)[2]. Metastatic breast cancer is
the most serious form of the disease and occurs when the cancer has spread to
other parts of the body, such as the brain, bones or liver[2]. Locally
advanced breast cancer occurs when the cancer has spread to lymph nodes
and/or other tissue in the area of the breast, but not to distant sites in
the body[2].

HR+/HER2- advanced breast cancer is the most common type of advanced breast
cancer, with an estimated 220,000 women diagnosed globally each year[3],[4].
HR+ advanced breast cancer is a group of cancers that express receptors for
certain hormones, such as estrogen and progesterone[5]. Cancer cell growth
can be driven by these hormones[5].


The foregoing release contains forward-looking statements that can be
identified by words such as "will," "pursue," "belief," "dedicated,"
"continuing," "commitment," "possible," "may," "to evaluate," "being
evaluated," "is evaluating," "is investigating," "are recruiting," or similar
terms, or by express or implied discussions regarding potential new
indications or labeling for LEE011, or regarding potential future revenues
from LEE011. 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 LEE011 will be
submitted or approved for any additional indications or labeling in any
market, or at any particular time. Nor can there be any guarantee that LEE011
will be commercially successful in the future. In particular, management's
expectations regarding LEE011 could be affected by, among other things, the
uncertainties inherent in research and development, including unexpected
clinical trial results and additional analysis of existing clinical data;
unexpected 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; competition in general;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected manufacturing, safety or quality 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, eye care and cost-saving generic pharmaceuticals. Novartis is the
only global company with leading positions in these areas. In 2015, the Group
achieved net sales of USD 49.4 billion, while R&D throughout the Group
amounted to approximately USD 8.9 billion (USD 8.7 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 118,000 full-time-equivalent associates. Novartis products are
available in more than 180 countries around the world. For more information,
please visit

Novartis is on Twitter. Sign up to follow @Novartis

For Novartis multimedia content, please For questions about the site or
required registration, please


[1] Novartis Data on File.
[2] American Cancer Society. How do you determine the stage of breast cancer?
Accessed May 10, 2016.

[3] Dobrescu A, et al. Study of Estrogen Receptor and Progesterone Receptor
Expression in Breast Ductal Carcinoma In Situ by Immunohistochemical Staining
in ER/PgR-Negative Invasive Breast Cancer. International Scholarly Research
Network. 2011;2011:1-5.
[4] Buckley N, et al. Breast Cancer. Decision Resources. March 2011:1-301.
[5] Redmond C. Breast Cancer Hormone Therapy Options. Available
Accessed December 1, 2014.

# # #

Novartis Media Relations

| Central media line : |
|+41 61 324 2200 |
| Eric Althoff Julie Masow |
| |
|Novartis Global Media Relations Novartis Oncology Media Relations |
|+41 61 324 7999 (direct) +1 862 778 7220 (direct) |
|+41 79 593 4202 (mo...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.