EAST HANOVER,
N.J., Nov. 1, 2017
/PRNewswire/ -- Novartis will present new data from
across its hematology portfolio at the upcoming 59th
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™*
(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
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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
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materialize, or should underlying assumptions prove incorrect,
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investigational or approved products described in this press
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providing the information in this press release as of this date and
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About Novartis
Located in East Hanover, NJ Novartis Pharmaceuticals
Corporation is an affiliate of Novartis which 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
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please visit http://www.novartis.com.
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* 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@novartis.com
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Eric
Althoff
Novartis Global Media
Relations
+41 61 324 7999
(direct)
+41 79 593 4202
(mobile)
eric.althoff@novartis.com
|
Michael
Billings
Novartis Oncology
Communications
+1 862 778 8656
(direct)
+1 201 400 1854
(mobile)
michael.billings@novartis.com
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SOURCE Novartis Pharmaceuticals Corporation