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2016-05-18

Novartis International AG: Novartis to present pivotal data in hematologic and solid tumor cancers at 2016 ASCO Annual Meeting

Novartis International AG / Novartis to present pivotal data in hematologic
and solid tumor cancers at 2016ASCO Annual Meeting . Processed and
transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
* First data from two treatment-free remission (TFR) studies of Ph+ CML
patients treated with Tasigna®both in front-line and second-line following
Glivec®*
* First genomic analysis and 3-year efficacy/safety update for Tafinlar®+
Mekinist®combination in BRAF V600E/K-mutant advanced melanoma, one of the
most mature overall survival follow ups to date

* Data from open-label Phase II trial of investigational Tafinlar®and
Mekinist®combination in previously-treated BRAF V600E-mutant advanced NSCLC

Basel, May 18, 2016
- Novartis will highlight the strength of its oncology research programs at
the upcoming 52ndAnnual Meeting of the American Society of Clinical Oncology
(ASCO), being held June 3-7 in Chicago. Data will demonstrate advances across
several of the company's core disease areas of focus including leukemias and
lung, melanoma and breast cancers.

"We are particularly excited to share the results from the Tasigna
Treatment-free Remission trials as these represent our unwavering commitment
to further understand management approaches for Philadelphia
chromosome-positive chronic myeloid leukemia," said Bruno Strigini, President
of Novartis Oncology. "These and other data at ASCO 2016 underscore our drive
to advance cancer research for the benefit of patients."

Novartis data at the 2016 ASCO Annual Meeting will highlight the following:

The potential for some patients with Philadelphia chromosome-positive (Ph+)
chronic myeloid leukemia (CML), treated with Tasigna

®
(nilotinib), to achieve a sustained deep level of molecular response and
maintain a major molecular response after stopping therapy - a concept called
Treatment-free Remission (TFR):

* Treatment-free remission (TFR) in patients (pts) with chronic myeloid
leukemia in chronic phase (CML-CP) treated with frontline nilotinib:
Results from the ENESTFreedom study [Abstract #7001; Saturday, June 4, 3:12
PM CDT]
* Treatment-free remission (TFR) in patients (pts) with chronic myeloid
leukemia in chronic phase (CML-CP) treated with second-line nilotinib
(NIL): First results from the ENESTop study [Abstract #7054; Monday, June
6, 8:00 AM CDT]

Update on the efficacy and safety of Tafinlar®(dabrafenib) and
Mekinist®(trametinib)

combination therapy in patients with BRAF V600-mutated cancers, including
potential indications under investigation:

* Genomic analysis and 3-y efficacy and safety update of COMBI-d: A Phase III
study of dabrafenib (D) + trametinib (T) vs D monotherapy in patients with
unresectable or metastatic BRAF V600E/K-mutant cutaneous melanoma [Abstract
#9502; Monday, June 6, 1:39 PM CDT]
* An open-label Phase II trial of dabrafenib (D) in combination with
trametinib (T) in patients with previously treated BRAF V600E-mutant
advanced non-small cell lung cancer (NSCLC; BRF113928) [Abstract #107;
Monday, June 6, 9:57 AM CDT]
* ROAR: A Phase II, open-label study in patients with BRAF V600E-mutated rare
cancers to investigate the efficacy and safety of dabrafenib (D) and
trametinib (T) combination therapy [Abstract # TPS2604; Sunday, June 5,
8:00 AM CDT]

Update on CTL019, an investigational Chimeric Antigen Receptor T cell (CAR T)
therapy, in relapsed/refractory pediatric acute lymphoblastic leukemia (ALL):

* Sustained remissions with CD19-specific chimeric antigen receptor
(CAR)-modified T cells in children with relapsed/refractory ALL [Abstract
#3011; Monday, June 6, 4:54 PM CDT]

Ongoing investigation of established and pipeline therapies for patients with
unmet needs:

* Long-term outcomes of ruxolitinib (RUX) therapy in patients with
myelofibrosis (MF): 5-year update from COMFORT-I [Abstract #7012; Monday,
June 6, 11:30 AM CDT]**
* Phase I study of the safety and efficacy of the cMET inhibitor capmatinib
(INC280) in patients (pts) with advanced cMET+ non-small cell lung cancer
(NSCLC) [Abstract #9067; Saturday, June 4, 8:00 AM CDT]

Additional notable data from Novartis' core disease areas of focus include:

Breast Cancer:

* A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years
after completing an initial 5 years of aromatase inhibitor therapy alone or
preceded by tamoxifen in postmenopausal women with early-stage breast
cancer [Abstract #LBA1; Sunday, June 5, 1:40 PM CDT]
* Patient-reported outcomes from MA.17R: A randomized trial of extending
adjuvant letrozole for 5 years after completing an initial 5 years of
aromatase inhibitor therapy alone or preceded by tamoxifen in
postmenopausal women with early-stage breast cancer [Abstract #LBA506;
Monday, June 6, 3:15 PM CDT]
* Correlation of PIK3CA mutations in cell-free DNA (cfDNA) and efficacy of
everolimus (EVE) in metastatic breast cancer: Results from BOLERO-2
[Abstract #519; Sunday, June 5, 11:30 AM CDT]
* Prevention of everolimus/exemestane (EVE/EXE) stomatitis in postmenopausal
(PM) women with hormone receptor-positive (HR+) metastatic breast cancer
(MBC) using a dexamethasone-based mouthwash (MW): Results of the SWISH
trial [Abstract #525; Sunday, June 5, 8:00 AM CDT]
* Evaluation of lapatinib as a component of neoadjuvant therapy for HER2+
operable breast cancer: 5-year outcomes of NSABP protocol B-41 [Abstract
#501; Monday, June 6, 1:27 PM CDT]
* Ribociclib (LEE011) and letrozole in estrogen receptor-positive (ER+),
HER2-negative (HER2-) advanced breast cancer (aBC): Phase Ib safety,
preliminary efficacy and molecular analysis [Abstract #568; Sunday, June 5,
8:00 AM CDT]

Lung Cancer:

* Genetic landscape of ALK+ non-small cell lung cancer (NSCLC) patients and
response to ceritinib in ASCEND-1 [Abstract #9064; Saturday, June 4, 8:00
AM CDT]
* Phase II safety and efficacy results of a single-arm Ph Ib/II study of
capmatinib (INC280) + gefitinib in patients with EGFR-mutated (mut),
cMET-positive (cMET+) non-small cell lung cancer (NSCLC) [Abstract #9020;
Saturday, June 4, 3:00 PM CDT]

Hematology:

* PILLAR-2: A randomized, double-blind, placebo-controlled, Phase III study
of adjuvant everolimus (EVE) in patients (pts) with poor-risk diffuse large
B-cell lymphoma (DLBCL) [Abstract #7506; Sunday, June 5, 11:45 AM CDT]
* ReTHINK: A randomized, double-blind, placebo-controlled, multicenter, Phase
III study of ruxolitinib in early myelofibrosis patients [Abstract
#TPS7080; Monday, June 6, 8:00 AM CDT]**
* Patient reported outcomes (PROs) of multiple myeloma (MM) patients treated
with panobinostat (PAN) after>=2 lines of therapy based on the
international Phase III, randomized, double-blind, placebo-controlled,
PANORAMA-1 trial [Abstract #8054; Monday, June 6, 8:00 AM CDT]

Other Tumor Types:

* A first-in-human phase I study of the anti-PD-1 antibody PDR001 in patients
with advanced solid tumors [Abstract #3060; Sunday, June 5, 8:00 AM CDT]
* BERIL-1: A Phase II, placebo-controlled study of buparlisib (BKM120) plus
paclitaxel vs placebo plus paclitaxel in patients with platinum-pretreated
recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
[Abstract #6008; Sunday, June 5, 10:12 AM CDT]
* BERIL-1: Biomarker results from targeted sequencing of circulating tumor
DNA (ctDNA) and archival tissue in a randomized Phase II study of
buparlisib (BKM120) or placebo + paclitaxel in patients with head and neck
squamous cell carcinoma (HNSCC) [Abstract #6045; Saturday, June 4, 1:00 PM
CDT]
* A Phase II study of the efficacy and safety of the cMET inhibitor
capmatinib (INC280) in patients (pts) with advanced hepatocellular
carcinoma (HCC) [Abstract #4074; Saturday, June 4, 8:00 AM CDT]
* Everolimus (EVE) in advanced, nonfunctional, well-differentiated
neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin: Second
interim overall survival (OS) results from the RADIANT-4 study [Abstract
#4090; Saturday, June 4, 8:00 AM CDT]
* Genomic mutation profiling (GMP) and clinical outcome in patients (pts)
treated with ribociclib (CDK4/6 inhibitor) in the Signature program
[Abstract 2528; Sunday, June 5, 8:00 AM CDT]

Throughout the 2016 ASCO Annual Meeting, Novartis Oncology will host dedicated
content on the company website (http://www.novartisoncology.com) that will
feature unique insights and perspectives on 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
https://www.novartisoncology.com/news/product-portfolio.

Because INC280, CTL019, LEE011, BKM120 and PDR001 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 INC280, CTL019, LEE011, BKM120 and PDR001 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 "to present," "investigational," "will,"
"upcoming," "excited," "commitment," "drive," "potential," "ongoing,"
"pipeline," "emerging," "yet," or similar terms, or by express or implied
discussions regarding potential new indications or labeling for Tafinlar
(dabrafenib) and Mekinist (trametinib) combination therapy, Tasigna
(nilotinib), Glivec (imatinib), Femara (letrozole), everolimus, Tykerb
(lapatinib), Zykadia (ceritinib), Farydak (panobinostat) and Jakavi
(ruxolitinib), regarding potential marketing approvals for BKM120, PDR001,
CTL019, INC280 and LEE011 or regarding potential future revenues from such
products and development projects. 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...

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