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2016-11-16

Novartis International AG: Novartis data at ASH and SABCS showcase latest innovations in development for patients with blood disorders and breast cancer

Novartis International AG / Novartis data at ASH and SABCS showcase latest
innovations in development forpatients with blood disorders and breast cancer
. Processed and transmitted by Nasdaq Corporate Solutions.The issuer is
solely responsible for the content of this announcement.
* First results from global registrational trial of CAR T therapy, CTL019, in
pediatric relapsed/refractory acute lymphoblastic leukemia
* Sub-group analyses from pivotal MONALEESA-2 trial of LEE011 (ribociclib)
plus letrozole in women with HR+/HER2- advanced breast cancer
* Post-hoc analysis of Tasigna®(nilotinib) treatment-free remission rates in
patients who switched from imatinib due to intolerance, resistance or
physician preference

Basel, November 16, 2016
- Novartis will present data demonstrating the latest advancements from its
oncology research program at the 58thAmerican Society of Hematology (ASH)
Annual Meeting&Exposition, San Diego, December 3-6, and the San Antonio
Breast Cancer Symposium (SABCS), San Antonio, December 6-10. Presentations
will focus on a number of cancers, including leukemia, lymphoma,
myelofibrosis and breast cancer, as well as chronic iron overload. The data
reinforce Novartis' dedication to developing transformative therapies and
treatment strategies to improve and extend the lives of people living with
these diseases.

"Novartis continues to invest in not only creating new medicines for
underserved patient communities, but also in redefining cancer treatment
goals," said Bruno Strigini, CEO, Novartis Oncology. "Our ASH and SABCS data,
including personalized cell and targeted therapies of the future, underscore
our core belief in treating each patient as an individual, not just the
disease."

Most notable among Novartis' clinical data to be featured at the two meetings
are from the ongoing registrational trials for investigational CTL019* and
LEE011** (ribociclib). The CTL019 data will be included in upcoming
regulatory submissions. Novartis also recently received US Food and Drug
Administration Priority Review for LEE011 (ribociclib) plus letrozole as
first-line treatment for postmenopausal women with HR+/HER2- advanced or
metastatic breast cancer, based on results from the MONALEESA-2 study.

* Analysis of a Global Registration Trial of the Efficacy and Safety of
CTL019 in Pediatric and Young Adults with Relapsed/Refractory Acute
Lymphoblastic Leukemia (ALL) (Abstract #221, Oral Presentation, Saturday,
December 3, 5:00 pm PST)
* First-Line Ribociclib Plus Letrozole in Patients with De Novo HR+/HER2-
Advanced Breast Cancer (ABC): A Subgroup Analysis of the MONALEESA-2 Trial
(Abstract #P4-22-05, Poster Presentation, Friday, December 9, 7:30 - 9:00
am CST)
* First-Line Ribociclib Plus Letrozole in Patients with HR+/HER2- Advanced
Breast Cancer (ABC) Presenting with Liver and/or Lung Metastases or
Bone-Only Disease: A Subgroup Analysis of the MONALEESA-2 trial (Abstract
#P4-22-16, Poster Presentation, Friday, December 9, 7:30 - 9:00 am CST)

Novartis will also be presenting safety, efficacy and quality of life data at
ASH from its hematology portfolio, including an investigational use for
Tasigna®(nilotinib). Five-year pooled overall survival data for
Jakavi®(ruxolitinib)*** in patients with myelofibrosis and patient-reported
health-related outcomes from patients with chronic immune thrombocytopenia
taking Revolade®(eltrombopag)**** will also be presented.

* Treatment-Free Remission in Patients with Chronic Myeloid Leukemia in
Chronic Phase According to Reasons for Switching from Imatinib to
Nilotinib: Subgroup Analysis from ENESTop (Abstract #792, Oral
Presentation, Monday, December 5, 11:45 am PST)
* A Pooled Overall Survival Analysis of 5-Year Data from the COMFORT-I and
COMFORT-II Trials of Ruxolitinib for the Treatment of Myelofibrosis
(Abstract #3110, Poster Presentation, Sunday, December 4, 6:00 - 8:00 pm
PST)
* The Impact of Myeloproliferative Neoplasms (MPNs) on Patients' Quality of
Life and Productivity: Results from the International MPN LANDMARK Survey
(Abstract #4267, Poster Presentation, Monday, December 5, 6:00 - 8:00 pm
PST)
* Patient-Reported Health-Related Quality of Life Improves Over Time in
Patients with Chronic Immune Thrombocytopenia Receiving Long-Term Treatment
with Eltrombopag (Abstract #3750, Poster Presentation, Monday, December 5,
6:00 - 8:00 pm PST)

Sandoz, a Novartis division, the pioneer and global leader in biosimilars,
will present pivotal Phase III safety and efficacy data for its proposed
biosimilar rituximab.

* A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar
GP2013 versus Rituximab in Patients with Previously Untreated Advanced
Follicular Lymphoma (Abstract #1809, Poster Presentation, Saturday,
December 3, 5:30 - 7:30 pm PST)

Additional abstracts of note from each meeting are as follows.

ASH: Data for investigational therapies

ABL001

* Expanded Phase I Study Update of ABL001, a Potent, Allosteric Inhibitor of
BCR-ABL, Reveals Significant and Durable Responses in Patients with
CML-Chronic Phase with Failure of Prior TKI Therapy (Abstract #625, Oral
Presentation, Monday, December 5, 7:00 am PST)

CTL019

* Efficacy and Safety of CTL019 in the First US Phase II Multicenter Trial in
Pediatric Relapsed/Refractory Acute Lymphoblastic Leukemia: Results of an
Interim Analysis (Abstract #2801, Poster Presentation, Sunday, December 4,
6:00 - 8:00 pm PST)
* Treatment with Chimeric Antigen Receptor Modified T Cells Directed Against
CD19 (CTL019) Results in Durable Remissions in Patients with Relapsed or
Refractory Diffuse Large B Cell Lymphomas of Germinal Center and
Non-Germinal Center Origin, "Double Hit" Diffuse Large B Cell Lymphomas,
and Transformed Follicular to Diffuse Large B Cell Lymphomas (Abstract
#3026, Poster Presentation, Sunday, December 4, 6:00 - 8:00 pm PST)

PKC412 (midostaurin)

* Radius: A Phase II, Randomized Trial of Standard of Care (SOC) with or
without Midostaurin to Prevent Relapse Following Allogeneic Hematopoietic
Stem Cell Transplantation in Patients with FLT3-ITD Mutated Acute Myeloid
Leukemia (Abstract #2248, Poster Presentation, Saturday, December 3, 5:30 -
7:30 pm PST)

ASH: Data for approved therapies

Exjade®/Jadenu(TM) (deferasirox)

* Improved Patient-Reported Outcomes with a Film-Coated Versus Dispersible
Tablet Formulation of Deferasirox: Results from the Randomized, Phase II
ECLIPSE Study (Abstract #850, Oral Presentation, Monday, December 5, 3:30
pm PST)
* New Film-Coated Tablet Formulation of Deferasirox is Well Tolerated in
Patients with Thalassemia or MDS: Results of the Randomized, Phase II
ECLIPSE Study (Abstract #1285, Poster Presentation, Saturday, December 3,
5:30 - 7:30 pm PST)

Jakavi®(ruxolitinib)

* Effects of Long-Term Ruxolitinib (RUX) on Bone Marrow (BM) Morphology in
Patients with Myelofibrosis (MF) Enrolled in the COMFORT-I Study (Abstract
#1949, Poster Presentation, Saturday, December 3, 5:30 - 7:30 pm PST)
* Safety and Efficacy of Ruxolitinib for the Final Enrollment of JUMP: An
Open-Label, Multicenter, Single-Arm, Expanded-Access Study in Patients with
Myelofibrosis (N = 2233) (Abstract #3107, Poster Presentation, Sunday,
December 4, 6:00 - 8:00 pm PST)

ASH: Investigational use of approved therapies

Revolade®/Promacta®(eltrombopag)

* Thrombopoietin (TPO) Receptor Agonist Eltrombopag in Combination with
Azacitidine (AZA) for Primary Treatment of Myelodysplastic Syndromes (MDS)
Patients with Thrombocytopenia: Outcomes from the Randomized,
Placebo-Controlled, Phase III SUPPORT Study (Abstract #163, Oral
Presentation, Saturday, December 3, 2:00 pm PST)

Tasigna®(nilotinib)

* ENESTPath: A Phase III Study to Assess the Effect of Nilotinib Treatment
Duration on Treatment-Free Remission (TFR) in Patients with Chronic
Phase-Chronic Myeloid Leukemia Previously Treated with Imatinib: 24-Month
Analysis of the First 300 Patients in the Induction/Consolidation Phase
(Abstract #3094, Poster Presentation, Sunday, December 4, 6:00 - 8:00 pm
PST)

SABCS:
Data for investigational therapies

LEE011 (ribociclib)

* Ribociclib + Fulvestrant in Postmenopausal Women with HR+/HER2- Advanced
Breast Cancer (ABC) (Abstract #P4-22-12, Poster Presentation, Friday,
December 9, 7:30 - 9:00 am CST)
* Phase Ib Safety, Efficacy and Molecular Analysis of Ribociclib (LEE011)
plus Letrozole for the Treatment of ER+/HER2- Advanced Breast Cancer
(Abstract #P4-22-18, Poster Presentation, Friday, December 9, 7:30 - 9:00
am CST)

BKM120 (buparlisib)

* BELLE-3: A Phase III Study of Buparlisib + Fulvestrant in Postmenopausal
Women with HR+/HER2-, Aromatase Inhibitor-Treated, Locally Advanced or
Metastatic Breast Cancer, who Progressed on or after mTOR Inhibitor-Based
Treatment (Abstract #S4-07, Oral Presentation, Thursday, December 8, 4:45
pm CST)

SABCS: Investigational use of approved therapies

Afinitor®(everolimus)

* PrECOG 0102: A Randomized, Double-Blind, Phase II Trial of Fulvestrant Plus
Everolimus or Placebo in Postmenopausal Women with Hormone Receptor
(HR)-Positive, HER2-Negative Metastatic Breast Cancer (MBC) Resistant to
Aromatase Inhibitor (AI) Therapy (Designed and conducted independently by
PrECOG, LLC with partial support from Novartis) (Abstract S1-02, Oral
Presentation, Wednesday, December 7, 9:00 am CST)

Novartis Oncology will host dedicated content on the company website
(http://www.novartisoncology.com) throughout ASH and SABCS, featuring unique
insights and perspectives on emerging areas of cancer care and research.
Additionally, follow@NovartisCanceron Twitter for the latest oncology news
and insights on cancer 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 the compounds will
become commercially available with additional indications.

For full prescribing information, including approved indications and important
safety information about globally marketed products, please visit
https://www.novartisoncology.com/our-work/product-portfolio.

Because CTL019, LEE011 (ribociclib), ABL001, PKC412 (midostaurin) and BKM120
(buparlisib) are investigational compounds, the safety and efficacy profiles
have not yet been fully established. Access to these investigational
compounds is av...

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