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2014-05-22

Novartis International AG: Novartis presents key advances in cancer research at ASCO and EHA from four new pivotal studies in lung, blood and skin cancers

Novartis International AG / Novartis presents key advances in cancer research
at ASCO and EHA from four newpivotal studies in lung, blood and skin cancers
. Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is
solely responsible for the content of this announcement.
* Pivotal data in ALK+ NSCLC for Zykadia(TM); recently approved by US FDA,
marking fastest oncology approval under Breakthrough Therapy designation

* First presentation of pivotal data from Phase III trial of Jakavi® in
polycythemia vera and LBH589 in multiple myeloma; blood cancers with unmet
medical need

* New LDE225 pivotal data unveiled in patients with advanced basal cell
carcinoma, the most common form of skin cancer with limited treatment
options

* More than 150 abstracts highlighting Novartis therapies include latest
analyses of Tasigna®, Afinitor® and Exjade®, as well as pipeline
combinations

Basel, May 22, 2014
-
Novartis will showcase the results of research efforts to target disease
pathways with more than 150 abstracts at two upcoming cancer-focused
meetings, including updated data in ALK+ non-small cell lung cancer and the
first-ever presentations of key data in polycythemia vera, multiple myeloma
(blood) and locally advanced or metastatic basal cell carcinoma (skin).

Clinical data featured at the 50th Annual Meeting of the American Society of
Clinical Oncology (ASCO; May 30-June 3, Chicago) and the 19th Congress of the
European Hematology Association (EHA; June 12-15, Milan) will include
Zykadia(TM)(ceritinib), Jakavi®[*](ruxolitinib), Tasigna®(nilotinib),
Afinitor®(everolimus) and Exjade®(deferasirox), as well as pipeline
compounds LBH589 (panobinostat), LDE225 (sonidegib) and others[1],[2].

"Our research strategy continues to focus on the underlying cause of disease
to develop targeted compounds or combinations of therapies," said Alessandro
Riva, MD, President, Novartis Oncology ad interim and Global Head, Oncology
Development and Medical Affairs. "The approach has been shown to be
successful in treating patients with lung, blood and breast cancers, and this
latest research shows that we may have potential new treatments to continue
addressing critical needs in cancer care."

Data highlights include:

Key pivotal data across four oncology compounds

* Ceritinib: Ceritinib in advanced anaplastic lymphoma kinase
(ALK)-rearranged (ALK+) non-small cell lung cancer (NSCLC): Results of the
ASCEND-1 trial (ASCO oral presentation, abstract #8003; June 2, 3:48 PM
CDT)
* Ruxolitinib: Results of a prospective, randomized, open-label Phase III
study of ruxolitinib in polycythemia vera patients resistant to or
intolerant of hydroxyurea: the RESPONSE trial (ASCO oral presentation,
abstract #7026; June 3, 9:57 AM CDT; EHA oral presentation, abstract
#LB-2436; June 14, 2:00 PM CEST)
* Panobinostat: PANORAMA 1: A randomized, double-blind, Phase III study of
panobinostat or placebo plus bortezomib and dexamethasone in relapsed or
relapsed and refractory multiple myeloma (ASCO oral presentation, abstract
#8510; June 2, 8:00 AM CDT; EHA oral presentation, abstract #S641; June 14,
8:00 AM CEST)
* Sonidegib: Randomized, double-blind study of sonidegib (LDE225) in patients
with locally advanced or metastatic basal cell carcinoma (ASCO oral
presentation, abstract #9009a; June 1, 8:00 AM CDT)

Emerging data on key Novartis marketed treatments, early combination studies
and innovative clinical trial designs

* Everolimus: Meta-analysis of stomatitis incidence in everolimus clinical
studies and its relationship with efficacy (ASCO abstract #645; June 2,
8:00 AM CDT)
* Everolimus: Prevention of stomatitis in patients with hormone
receptor-positive advanced breast cancer treated with everolimus plus
exemestane: A Phase II study of a steroid-based mouthwash (ASCO trials in
progress abstract #TPS661; June 2, 8:00 AM CDT)
* Everolimus: Identification and validation of predictive biomarkers for
everolimus in metastatic renal cell carcinoma: Analysis of 442 patients on
RECORD-3 (ASCO abstract #4531; May 30, 1:00 PM CDT)
* Nilotinib: Treatment-free remission following nilotinib in patients with
chronic myeloid leukemia in chronic phase: ENESTfreedom, ENESTop,
ENESTgoal, and ENESTpath (ASCO trials in progress abstract #TPS7124; June
2, 1:15 PM CDT)
* Nilotinib: ENESTnd 5-year update: Long-term outcomes of patients with
chronic myeloid leukemia in chronic phase treated with frontline nilotinib
vs imatinib (ASCO abstract #7073; June 2, 1:15 PM CDT; EHA oral
presentation, abstract #S677; June 14, 8:15 AM CEST)
* Nilotinib: Effect of continued imatinib in patients with detectable BCR-ABL
after>= 2 years on study on deep molecular responses (MR): 36-month update
from ENESTcmr (ASCO abstract #7025; May 31, 1:15 PM CDT; EHA oral
presentation, abstract #S1361; June 15, 10:45 AM CEST)
* Ruxolitinib: Phase Ib, dose-finding study of ruxolitinib plus panobinostat
in patients with myelofibrosis (ASCO abstract #7022; May 31, 1:15 PM CDT;
EHA abstract #P410; June 13, 5:45-7:00 CEST)
* Deferasirox: Deferasirox-deferoxamine combination therapy reduces cardiac
iron with rapid liver iron removal after 24 months in patients with severe
transfusional iron overload (HYPERION) (EHA abstract #S661; June 14, 8:00
AM CEST)
* The signature program, a series of tissue-agnostic, mutation-specific
signal finding trials (ASCO trials in progress abstract #TPS2646; June 1,
8:00 AM CDT)

New findings from combination studies across oncology pipeline and
presentations on CAR T cell therapy

* INC280: Safety and efficacy of INC280 in combination with gefitinib in
patients with EGFR-mutated, MET-positive NSCLC: A single-arm Phase lb/ll
study (ASCO abstract #8017; June 3, 8:00 AM CDT)
* LEE011: Phase Ib/II study of LEE011, everolimus, and exemestane in
postmenopausal women with ER+/HER2- metastatic breast cancer (ASCO abstract
#535; June 1, 8:00 AM CDT)
* LEE011: Phase Ib study of LEE011 and BYL719 in combination with letrozole
in estrogen receptor-positive, HER2-negative breast cancer (ASCO abstract
#533; June 1, 8:00 AM CDT)
* CTL019: Genetically Engineered T Cells and Beyond: Immune Modulation
Therapy in Chronic Lymphocytic Leukemia (ASCO; June 2, 1:55 PM CDT)
* CTL019: Future Directions in Immune Targeting (ASCO; June 2, 1:35 PM CDT)

Throughout ASCO and EHA, Novartis Oncology will host a dedicated webpage
(http://www.novartisoncology.com/asco-2014.jsp) that will provide unique
insights and perspectives into emerging areas of cancer care and research.

Product Information
Approved indications for products vary by country and not all indications are
available in every country. The product safety and efficacy profiles have not
yet been established outside the approved indications. Because of the
uncertainty of clinical trials, there is no guarantee that compounds will
become commercially available with additional indications.

For full prescribing information including important safety information about
marketed products, please the following
websites:www.zykadia.com,www.jakavi.com,www.tasigna.com,www.glivec.com,www.afinit....

Because LBH589, LDE225, INC280, LEE011, BYL719 and CTL019 are investigational
compounds, the safety and efficacy profiles have not yet been fully
established. Access to these investigational compounds is available only
through carefully controlled and monitored clinical trials. These trials are
designed to better understand the potential benefits and risks of the
compound. Because of the uncertainty of clinical trials, there is no
guarantee that LBH589, LDE225, INC280, LEE011, BYL719 and/or CTL019 will ever
be commercially available anywhere in the world.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "presents," "will," "upcoming," "pipeline,"
"strategy," "continues," "to focus," "to develop," "may," "potential," "to
continue," "emerging," "in progress," "investigational," or similar terms,
or by express or implied discussions regarding potential new indications or
labeling for Zykadia, Jakavi, Tasigna, Glivec, Afinitor or Exjade, potential
marketing approvals for LBH589, LDE225, INC280, LEE011, BYL719, CTL019 or
other investigational treatments in the Novartis Oncology pipeline or
regarding potential future revenues from such products. 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 LBH589, LDE225, INC280, LEE011, BYL719, CTL019
or any other investigational treatment in the Novartis Oncology pipeline will
be submitted or approved for sale in any market, or at any particular time.
Neither can there be any guarantee that Zykadia, Jakavi, Tasigna, Glivec,
Afinitor or Exjade 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 such products and investigational treatments will
be commercially successful in the future. In particular, management's
expectations regarding such products and investigational treatments 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; global trends toward health care cost containment,
including ongoing pricing pressures; unexpected manufacturing 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, cost-saving generic pharmaceuticals, preventive
vaccines, over-the-counter and animal health products. ...

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