Novartis presents new data on 21 medicines and 11 investigational compounds at ASCO and EHA
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Novartis International AG /
Novartis presents new data on 21 medicines and 11 investigational compounds at
ASCO and EHA
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* Overall survival data for Tafinlar(®) and Mekinist(®) combination to be
presented in metastatic BRAF V600E/K mutation-positive cutaneous melanoma
* New data for Zykadia(®) in ALK+ non-small cell lung cancer (NSCLC) and first
Phase II data for Tafinlar and Mekinist in BRAF mutant NSCLC
* Early data indicate the potential of CAR T therapies in a variety of cancers
including lymphoma, multiple myeloma and pancreatic cancer
* Latest advances in hematology treatments for CML with Tasigna(®), CLL with
Arzerra(®), multiple myeloma with Farydak(®), and polycythemia vera with
Jakavi(®)
Basel, May 27, 2015 - Novartis will highlight the strength of its expanded
oncology portfolio in 21 medicines and 11 investigational compounds across more
than 185 data presentations at the upcoming American Society of Clinical
Oncology (ASCO) Annual Meeting, May 29-June 2, and the Congress of the European
Hematology Association (EHA), June 11-14. Data will demonstrate advances in
research in a variety of cancer types, including melanoma, lung, breast, kidney
and blood cancers, underscoring Novartis' leadership in developing treatments
with the potential to improve and possibly extend the lives of people with solid
and hematologic tumors[1],[2].
"Novartis is proud to showcase our portfolio of medicines, enhanced by the
acquisition of oncology products and related assets from GSK," said Bruno
Strigini, President of Novartis Oncology. "In addition to new data across many
disease areas, we look forward to presenting the overall survival data for the
combination regimen of two of the assets we acquired - Tafinlar and Mekinist -
as these targeted therapies play a critical role for certain patients fighting
metastatic melanoma. These medicines - plus the many others highlighted at ASCO
and EHA - exemplify our mission to transform cancer care."
Key data presentations show potential benefit of identifying tumor-specific
biomarkers and combination treatment strategies:
* Tafinlar(®) (dabrafenib) and Mekinist(®) (trametinib): Full COMBI-d overall
survival data in metastatic BRAF V600E/K mutation-positive cutaneous
melanoma (ASCO Abstract #102; May 31, 9:45 AM CDT), and interim results of a
Phase II study of the BRAF inhibitor dabrafenib in combination with the MEK
inhibitor trametinib in patients with BRAF V600E mutated metastatic non-
small cell lung cancer (ASCO Abstract #8006; May 31, 10:00 AM CDT)
* Zykadia(® )(ceritinib): First presentation of data from Phase II ASCEND-2
and ASCEND-3 efficacy and safety studies in ALK+ non-small cell lung cancer
(NSCLC) (ASCO Abstract #8059; June 1, 8:00 AM CDT); (ASCO Abstract #8060;
June 1, 8:00 AM CDT)
* Afinitor(®) (everolimus): Identification of efficacy biomarkers in a large
metastatic renal cell carcinoma cohort through next-generation sequencing;
results from RECORD 3 (ASCO Abstract #4509; June 2, 9:45 AM CDT); biomarker
analysis of BOLERO-1 and BOLERO-3 in HER2+ breast cancer (ASCO Abstract
#512; May 31, 12:18 PM CDT)
"Our significant presence at ASCO demonstrates that Novartis is at the forefront
of transforming how cancer is managed and treated, with a commitment to genomic
medicine, innovative combinations, as well as the pursuit of scientific
partnerships to further advance drug discovery and development," said Alessandro
Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "Our
broad portfolio illustrates how we use scientific insights to 'starve or
destroy' cancer cells implicated in a wide range of tumor types."
Additional data being presented at ASCO and EHA evaluate efficacy and safety of
targeting multiple cancer pathways in a variety of solid tumors and blood
cancers:
* Phase I study of dabrafenib in pediatric patients (pts) with relapsed or
refractory BRAF V600E high- and low-grade gliomas (HGG, LGG), Langerhans
cell histiocytosis (LCH), and other solid tumors (OST) (ASCO Abstract
#10004; May 30, 4:12 PM CDT)
* A Phase I/II study of the combination of panobinostat (PAN) and carfilzomib
(CFZ) in patients (pts) with relapsed or relapsed/refractory multiple
myeloma (MM) (ASCO Abstract #8513; June 2, 11:33 AM CDT)
* Panobinostat plus bortezomib and dexamethasone in patients with relapsed or
relapsed and refractory multiple myeloma who received prior bortezomib and
IMiDs: A predefined subgroup analysis of PANORAMA 1 (ASCO Abstract #8526;
May 31, 8:00 AM CDT) (EHA Abstract #S102; June 12, 11:45 CEST)
Important studies feature Novartis precision medicines and scientific insight
based on genomic attributes of specific cancer types:
* Phase I study of ceritinib in pediatric patients (Pts) with malignancies
harboring a genetic alteration in ALK (ALK+); Safety, pharmacokinetic (PK),
and efficacy results (ASCO Abstract #10005; May 30, 4:24 PM CDT)
* First-in-human Phase I study of EGF816, a third generation mutant-selective
EGFR tyrosine kinase inhibitor, in advanced non-small cell lung cancer
(NSCLC) harboring T790M (ASCO Abstract #8013; June 1, 8:00 AM CDT)
* Effect of mutations in distinct components of the PI3K/AKT/mTOR pathway on
sensitivity to endocrine therapy in estrogen receptor (ER)-positive breast
cancer (ASCO Abstract #532; May 30, 8:00 AM CDT)
* Evaluation of possible linkage between everolimus benefit in estrogen
receptor (ER)-positive breast cancer and genomic alterations of the
PI3K/AKT/mTOR pathway (ASCO Abstract #530; May 30, 8:00 AM CDT)
Early data indicate the potential of Chimeric Antigen Receptor T cell (CAR T)
therapies in a variety of cancers including lymphoma, multiple myeloma and
pancreatic cancer:
* Phase IIa trial of chimeric antigen receptor modified T cells directed
against CD19 (CTL019) in patients with relapsed or refractory CD19+
lymphomas (ASCO Abstract #8516; June 1, 3:24 PM CDT)
* Safety and efficacy of anti-CD19 chimeric antigen receptor (CAR)-modified
autologous T cells (CTL019) in advanced multiple myeloma (ASCO Abstract
#8517; June 1, 3:36 PM CDT)
* Safety and antitumor activity of chimeric antigen receptor modified T cells
in patients with chemotherapy refractory metastatic pancreatic cancer (ASCO
Abstract #3007; June 1, 3:27 PM CDT)
Other noteworthy data to be presented at ASCO and EHA:
* Final overall survival analysis for the RECORD-3 study of first-line
everolimus followed by sunitinib versus first-line sunitinib followed by
everolimus in metastatic RCC (mRCC) (ASCO Abstract #4554; June 1, 1:15 PM
CDT)
* RECORD-4: A multicenter Phase II trial of second-line everolimus (EVE) in
patients (pts) with metastatic renal cell carcinoma (mRCC) (ASCO Abstract
#4518; June 1, 1:15 PM CDT)
* Efficacy and safety of frontline nilotinib in 1089 European patients (pts)
with chronic myeloid leukemia in chronic phase (CML-CP): ENEST1st final
analysis (EHA Abstract #S486, June 13, 3:45 PM CEST)
* Efficacy and safety of nilotinib vs. imatinib in newly diagnosed chronic
myeloid leukemia in chronic phase: 6-year follow-up of ENESTnd (EHA Abstract
#P228, June 12, 5:15 PM CEST)
* ENESTcmr 4-Y results: Patients (pts) with CML in chronic phase (CML-CP) and
residual disease more likely to achieve deep molecular response following
switch to nilotinib (NIL) (EHA Abstract #P229, June 12, 5:15 PM CEST)
* Ofatumumab (O) in combination with fludarabine (F) and cyclophosphamide (C)
(OFC) vs. FC in patients with relapsed chronic lymphocytic leukaemia (CLL):
Results of the Phase III study COMPLEMENT 2 (EHA Late-Breaker Abstract
#LB219, June 12, 5:15 PM CEST)
* Ruxolitinib in polycythemia vera: Follow-up from the RESPONSE trial (ASCO
Abstract #7087; May 31, 8:00 AM CDT); (EHA Abstract #S447; June 13, 11:45 AM
CEST)
Throughout ASCO and EHA, Novartis Oncology will host a dedicated webpage
(www.novartisoncology.com/asco-2015.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 approved indications and important
safety information about marketed products, please visit
http://www.novartisoncology.com/products.jsp.
Because EGF816 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 EGF816 and 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 "investigational," "to be presented," "potential," "will,"
"look forward," "mission," "commitment," or similar terms, or by express or
implied discussions regarding potential new indications or labeling for
Tafinlar, Mekinist, Zykadia, Afinitor, Farydak, Tasigna, Glivec, Arzerra and
Jakavi, potential marketing approvals for EGF816 and CTL019, or regarding
potential future revenues from such products and investigational compounds. 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 any such products will be submitted or approved
for any additional indications or labeling in any market, or at any particular
time. Neither can there be any guarantee that EGF816 or CTL019 will be submitted
or approved for sale in any market, or at any particular time. Nor can there be
any guarantee that such products and investigational compounds will be
commercially successful in the future. In particular, management's expectations
regarding such products and investigational compounds 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 and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2014, the Group achieved net
sales of USD 58.0 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 120,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
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http://twitter.com/novartis.
References
[1] American Society of Clinical Oncology. ASCO Annual Meeting abstracts.
Available at: http://abstracts.asco.org. Accessed May 2015.
[2] European Hematology Association. EHA Annual Congress abstracts. Available
at
http://learningcenter.ehaweb.org/eha/#!*menu=16*browseby=2*sortby=1*media=
3*label=4267 Accessed May 2015.
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Datum: 27.05.2015 - 07:15 Uhr
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News-ID 395906
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