Novartis presents data at ASH for patients with serious blood disorders like lymphoma, leukemia and sickle cell disease
(Thomson Reuters ONE) -
Novartis International AG /
Novartis presents data at ASH for patients with serious blood disorders like
lymphoma, leukemia and sickle cell disease
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
* Primary results of pivotal Kymriah(TM) Phase II JULIET study in
relapsed/refractory DLBCL
* Post-hoc sub-analysis of crizanlizumab (SEG101, formerly SelG1) SUSTAIN
trial evaluating time to first sickle cell pain crisis
* Outcomes from matched analysis of Molecular Recurrence-free Survival from
EURO-SKI and ENESTfreedom trials following Tasigna(®) vs. imatinib in
patients with CML-CP eligible for Treatment-free Remission (TFR)
* Additional data on Rydapt(®), Revolade(®)/Promacta(®), Exjade(®)/Jadenu(®)
and Jakavi(®) underscore breadth of Novartis Oncology hematology portfolio
Basel, November 1, 2017 - Novartis will present new data from across its
hematology portfolio at the upcoming 59(th) American Society of Hematology (ASH)
Annual Meeting & Exposition, Atlanta, December 9-12. More than 75 abstracts will
be presented, highlighting the robust Novartis development program for serious
blood diseases.
"This is an exceptionally productive time in hematology, and the breadth of our
Novartis Oncology data and presence at ASH underscore our commitment to this
space," said Vas Narasimhan, Global Head Drug Development and Chief Medical
Officer, Novartis. "Following the launch of Kymriah, the first FDA-approved CAR-
T therapy, we are particularly excited about presenting additional data on this
new approach to cancer treatment, as well as a new analysis for crizanlizumab,
an investigational treatment for patients with sickle cell disease."
Kymriah(TM)* (tisagenlecleucel) suspension for intravenous infusion is a CD19-
directed genetically modified autologous T cell immunotherapy, indicated for the
treatment of patients up to 25 years of age with B-cell precursor acute
lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
Additional results evaluating Kymriah in pediatric ALL and in
relapsed/refractory diffuse large B-cell lymphoma (DLBCL) will be presented.
Data for Kymriah include results from the primary analysis of the JULIET study
in adult patients with relapsed or refractory DLBCL, demonstrating sustained
complete response rates based on extended follow up, and efficacy and safety
findings from additional treated patients compared to a previously presented
interim analysis. Additionally, results of a cost-effectiveness analysis of
Kymriah for the treatment of relapsed or refractory ALL in the United States
will be presented in an oral presentation.
* Primary Analysis of JULIET: A Global, Pivotal, Phase 2 Trial of CTL019 in
Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
[Abstract #577; Monday, December 11, 7:00 AM EST]
* Cost-Effectiveness Analysis of CTL019 for the Treatment of Pediatric and
Young Adult Patients with Relapsed or Refractory B-cell Acute Lymphoblastic
Leukemia in the United States [Abstract #609; Monday, December 11, 7:30 AM
EST]
* Patient-Reported Quality of Life (QoL) Following CTL019 Infusion in Adult
Patients with Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma
(DLBCL) [Abstract #5215; publication only]
* Expert Elicitation of Long-Term Survival for Pediatric Acute Lymphoblastic
Leukemia Patients Receiving CTL019 in ELIANA Phase II Study [Abstract #3377;
Sunday, December 10, 6:00 PM EST]
Outcomes for chimeric antigen receptor T cell (CAR-T) pipeline therapies in
other malignant blood cancers will also be shared at ASH:
* Updated Safety and Efficacy of B-cell Maturation Antigen (BCMA)-specific
Chimeric Antigen Receptor T Cells (CART-BCMA) for Refractory Multiple
Myeloma (MM) [Abstract #505; Sunday, December 10, 4:30 PM EST]
* Durable Remissions with Humanized CD19-Targeted Chimeric Antigen Receptor
(CAR)-Modified T Cells in Children and Young Adults with Relapsed/Refractory
Acute Lymphoblastic Leukemia, Including After Prior CAR Therapy [Abstract
#1319; Saturday, December 9, 5:30 PM EST]
Data from a post-hoc sub-group analysis of the Phase II SUSTAIN investigational
trial of crizanlizumab for time to first on-treatment sickle cell pain crisis
will be featured:
* Crizanlizumab 5.0 mg/kg Increased the Time to First On-Treatment Sickle Cell
Pain Crisis: A Subgroup Analysis of the Phase II SUSTAIN Study [Abstract
#613; Monday, December 11, 10:30 AM EST]
A matched comparison of Molecular Recurrence-free Survival (MRecFS) following
treatment discontinuation in chronic myeloid leukemia (CML) patients on
Tasigna(®) (nilotinib) in ENESTfreedom versus patients on imatinib in the EURO-
SKI trials will be presented in addition to updates from ENESTfreedom and
ENESTop on Treatment-free Remission (TFR) outcomes:
* Molecular Recurrence-Free Survival (MRecFS) Following Imatinib vs Nilotinib
in Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Matched
Analysis of Patients in EURO-SKI and ENESTfreedom [Abstract #1601; Saturday,
December 9, 5:30 PM EST]
* Impact of Treatment Cessation on Overall Disease Outcomes in Patients with
Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Attempting Treatment-Free
Remission (TFR): Findings from ENESTfreedom and ENESTop [Abstract #1598;
Saturday, December 9, 5:30 PM EST]
* Treatment-Free Remission (TFR) Among Patients with Chronic Myeloid Leukemia
in Chronic Phase (CML-CP) Not Initially Eligible for Treatment
Discontinuation Due to Unstable Deep Molecular Response (DMR): ENESTfreedom
and ENESTop [Abstract #2878; Sunday, December 10, 6:00 PM EST]
Additionally, new insights will be presented from the pivotal, Phase III RATIFY
trial of Rydapt(®) (midostaurin) in adults with FLT3+ acute myeloid leukemia
(AML):
* An Analysis of the Maintenance and Post Completion Effect of Midostaurin
Therapy in the International Prospective Randomized Placebo-Controlled,
Double-Blind Trial (CALGB 10603/RATIFY [Alliance]) for Newly Diagnosed Acute
Myeloid Leukemia (AML) Patients with FLT3 Mutations [Abstract #145;
Saturday, December 9, 12:00 PM EST]
* The Addition of Midostaurin to Standard Chemotherapy Decreases Cumulative
Incidence of Relapse (CIR) in the International Prospective Randomized,
Placebo-Controlled, Double-Blind Trial (CALGB 10603/RATIFY [Alliance]) for
Newly Diagnosed Acute Myeloid Leukemia (AML) Patients with FLT3 Mutations
[Abstract #2580; Sunday, December 10, 6:00 PM EST]
* Prognostic Impact of NPM1/FLT3-ITD Genotypes from Randomized Patients with
Acute Myeloid Leukemia (AML) Treated Within the International RATIFY Study
[Abstract #467; Sunday, December 10, 5:30 PM EST]
Sandoz, a Novartis division, the pioneer and global leader in biosimilars, will
present two studies examining the impact of granulocyte colony-stimulating
factor (G-CSF) on patient outcomes, cost savings and expanded access for
biosimilars including Zarxio(®) (filgrastim-sndz).
* Expanded Access to Obinutuzumab from Cost-Savings Generated by Biosimilar
Filgrastim (BIOSIM-FIL) in the Prophylaxis of Chemotherapy-Induced (Febrile)
Neutropenia: A Simulation Study [Abstract #3380; Sunday, December 10, 6:00
PM EST]
* A Systemic Literature Review of Overall Survival and Delivered Dose
Intensity in Cancer Patient Receiving Chemotherapy and G-CSF in Randomized
Control Trials [Abstract #3424; Sunday, December 10, 6:00 PM EST]
Additional abstracts of note from the meeting are as follows.
Exjade(®)/Jadenu(®) (deferasirox)
* Predicting Serum Ferritin Levels in Patients with Iron Overload Treated with
the Film-Coated Tablet of Deferasirox During the ECLIPSE Study [Abstract
#3508; Monday, December 11, 6:00 PM EST]
Jakavi(®) (ruxolitinib)**
* Primary Analysis of JUMP, a Phase 3b, Expanded-Access Study Evaluating the
Safety and Efficacy of Ruxolitinib in Patients with Myelofibrosis (N =
2233) [Abstract #4204; Monday, December 11, 6:00 PM EST]
* Results from the 208-Week (4-Year) Follow-Up of Response Trial, a Phase 3
Study Comparing Ruxolitinib (Rux) with Best Available Therapy (BAT) for the
Treatment of Polycythemia Vera (PV) [Abstract #322; Sunday, December
10, 7:30 AM EST]
* Role of Symptom Burden in Disability Leave Among Patients with
Myeloproliferative Neoplasms (MPNs): Findings from the Living with MPN
Patient Survey [Abstract #1637; Saturday, December 9, 5:30 PM EST]
Revolade(®)/Promacta(®) (eltrombopag)***
* Occurrence and Management of Cataracts in Patients with Chronic Immune
Thrombocytopenia (cITP) During Long-Term Treatment with Eltrombopag (EPAG):
Results from the EXTEND Study [Abstract #1053; Saturday, December 9, 5:30 PM
EST]
* Eltrombopag (EPAG) Treatment Improved Platelet Counts in Patients with
Persistent or Chronic Immune Thrombocytopenia During a 2-Year, Phase IV,
Open-Label Study [Abstract #3628; Monday, December 11, 6:00 PM EST]
* A Retrospective Chart Review to Assess Burden of Illness Among Patients with
Severe Aplastic Anemia with Insufficient Response to Immunosuppressive
Therapy [Abstract #678; Monday, December 11, 10:30 AM EST]
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.
Crizanlizumab, CART-BCMA and CTL119 are investigational compounds. Efficacy and
safety have not been established. There is no guarantee these compounds will
become commercially available.
Disclaimer
This press release contains forward-looking statements within the meaning of the
United States Private Securities Litigation Reform Act of 1995. Forward-looking
statements can generally be identified by words such as "potential," "can,"
"will," "plan," "expect," "anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by express or
implied discussions regarding potential marketing approvals, new indications or
labeling for the investigational or approved products described in this press
release, or regarding potential future revenues from such products. You should
not place undue reliance on these statements. Such forward-looking statements
are based on our current beliefs and expectations 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 the
investigational or approved products described in this press release will be
submitted or approved for sale or for any additional indications or labeling in
any market, or at any particular time. Nor can there be any guarantee that such
products will be commercially successful in the future. In particular, our
expectations regarding such products could be affected by, among other things,
the uncertainties inherent in research and development, including clinical trial
results and additional analysis of existing clinical data; regulatory actions or
delays or government regulation generally; our ability to obtain or maintain
proprietary intellectual property protection; the particular prescribing
preferences of physicians and patients; global trends toward health care cost
containment, including government, payor and general public pricing and
reimbursement pressures; general economic and industry conditions, including the
effects of the persistently weak economic and financial environment in many
countries; safety, quality or 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,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
121,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis and (at)NovartisCancer at
https://twitter.com/novartiscancer
For Novartis multimedia content, please visit www.novartis.com/news/media-
library
For questions about the site or required registration, please contact
media.relations(at)novartis.com
* Novartis and the University of Pennsylvania's Perelman School of Medicine
(Penn) have a global collaboration to research, develop and commercialize
chimeric antigen receptor T cell (CAR-T) therapies for the investigational
treatment of cancers.
** Jakavi is a registered trademark of Novartis AG in countries outside the
United States. Jakafi is a registered trademark of Incyte Corporation. Novartis
licensed ruxolitinib from Incyte Corporation for development and
commercialization outside the United States.
*** Marketed as Promacta(®) in the United States and as Revolade(®) outside the
United States.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
Eric Althoff Michael Billings
Novartis Global Media Relations Novartis Oncology Communications
+41 61 324 7999 (direct) +1 862 778 8656 (direct)
+41 79 593 4202 (mobile) +1 201 400 1854 (mobile)
eric.althoff(at)novartis.com michael.billings(at)novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations(at)novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media release (PDF):
http://hugin.info/134323/R/2146293/822977.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 01.11.2017 - 14:05 Uhr
Sprache: Deutsch
News-ID 566199
Anzahl Zeichen: 17353
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 283 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novartis presents data at ASH for patients with serious blood disorders like lymphoma, leukemia and sickle cell disease"
steht unter der journalistisch-redaktionellen Verantwortung von
Novartis International AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
