-
Updated analyses from the
Kisqali® pivotal Phase
III MONALEESA-2 trial in hormone receptor positive, human epidermal
growth factor receptor-2 negative (HR+/HER2-) advanced breast
cancer to be presented at ASCO
-
JULIET trial of CTL019
(tisagenlecleucel) in relapsed/refractory diffuse large B-cell
lymphoma (DLBCL) to be presented at ICML
-
New data from the CTL019 ELIANA
trial in pediatric and young adult patients with
relapsed/refractory B-cell acute lymphoblastic
leukemia (B-ALL) at EHA
-
New 96 week updates for
Tasigna®
Treatment-free Remission (TFR) trials evaluating Ph+ CML patients
in both first-line setting and after switch from Glivec®
at EHA
Basel, May 18, 2017 - Novartis will present data from across its oncology
portfolio at the upcoming 53rd Annual
Meeting of the American Society of Clinical Oncology (ASCO), being
held June 2-6 in Chicago; the 14th
International Conference on Malignant Lymphoma (ICML), being held
June 14-17 in Lugano, Switzerland; and the 22nd Annual
Congress of the European Hematology Association (EHA), being held
June 22-25 in Madrid. With more than 75 abstracts accepted, data
will highlight research across 34 compounds in key disease areas,
including breast and lung cancers, melanoma, leukemia and other
blood disorders, and myeloproliferative neoplasms (MPNs).
"Our presence at key medical congresses this year
is marked by our innovation in targeted therapies and
immuno-oncology in difficult to treat cancers," said Bruno
Strigini, CEO, Novartis Oncology. "We are particularly excited to
show the first data from the JULIET trial, which evaluates the use
of CTL019 in relapsed/refractory diffuse large B-cell lymphoma.
These results, along with the data that led to our filing for
CTL019 in relapsed/refractory pediatric and young adult patients
with B-cell acute lymphoblastic leukemia, demonstrate our
commitment to research in this area."
Novartis data at the 2017 ASCO
Annual Meeting will highlight the following:
Update on
outcomes with Kisqali®*
(ribociclib) in
postmenopausal women with hormone receptor positive, human
epidermal growth factor receptor-2 negative (HR+/HER2-) advanced
breast cancer:
-
Updated Results from MONALEESA-2, a Phase 3
Trial of First-Line Ribociclib + Letrozole in Hormone
Receptor-Positive (HR+), HER2-Negative (HER2-), Advanced Breast
Cancer (ABC) [Abstract #1038; Sunday, June 4, 8:00 AM CDT]
-
Health-Related Quality of Life (HRQoL) of
Postmenopausal Women with Hormone Receptor-Positive (HR+), Human
Epidermal Growth Factor Receptor 2-Negative (HER2-) Advanced Breast
Cancer (ABC) Treated with Ribociclib + Letrozole: Results from
MONALEESA-2 [Abstract #1020; Sunday, June 4, 8:00 AM CDT]
Data showing patient-reported
quality of life outcomes for CTL019** (tisagenlecleucel), an
investigational chimeric antigen receptor T cell (CAR-T) therapy,
in relapsed/refractory pediatric and young adult patients with
B-cell acute lymphoblastic leukemia (ALL):
-
Patient-Reported Quality of Life (QOL) Following
CTL019 in Pediatric and Young Adult Patients (pts) with
Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia
(B-ALL) [Abstract #10523; Sunday, June 4, 8:00 AM CDT]
New data
evaluating long-term outcomes with Tafinlar®
(dabrafenib) and Mekinist®
(trametinib) combination
therapy in patients with BRAF V600-mutated unresectable or
metastatic melanoma as well as data from patients with other tumor
types:
-
Five-Year Overall Survival (OS) Update from a
Phase II, Open-Label Trial of Dabrafenib (D) and Trametinib (T) in
Patients (pts) with BRAF V600-Mutant
Unresectable or Metastatic Melanoma (MM) [Abstract #9505; Sunday,
June 4, 9:24 AM CDT]
-
COMBI-MB: A Phase II Study of Combination
Dabrafenib (D) and Trametinib (T) in Patients with BRAF V600-Mutant (mut) Melanoma Brain Metastases (MBM)
[Abstract #9506; Sunday, June 4, 10:00 AM CDT]
-
Updated Survival of Patients (pts) with
Previously Treated BRAF V600E-Mutant Advanced
Non-Small Cell Lung Cancer (NSCLC) who Received Dabrafenib (D) or D
+ Trametinib (T) in the Phase II BRF113928 Study [Abstract #9075;
Saturday, June 3, 8:00 AM CDT]
-
Efficacy of Dabrafenib (D) and Trametinib (T) in
Patients (pts) with BRAF V600E-Mutated
Anaplastic Thyroid Cancer (ATC) [Abstract #6023; Monday, June 5,
1:15 PM CDT]
New data on
Zykadia® (ceritinib)
as well as the investigational compound EGF816 which highlight
continued investigations in the treatment of mutation-driven lung
cancer:
-
Ceritinib Plus Nivolumab (NIVO) in Patients
(pts) with Anaplastic Lymphoma Kinase Positive (ALK+) Advanced
Non-Small Cell Lung Cancer (NSCLC) [Abstract #2502; Saturday, June
3, 1:39 PM CDT]
-
Genomic Profiling of Resistant Tumor Samples
Following Progression on EGF816, a Third Generation,
Mutant-Selective EGFR Tyrosine Kinase Inhibitor (TKI), in Advanced
Non-Small Cell Lung Cancer (NSCLC) [Abstract #11506; Sunday, June
4, 9:48 AM CDT]
Adjuvant
treatment of renal cell carcinoma (RCC) and safety and efficacy of
combination therapy in treatment of advanced RCC:
- Randomized Phase III Trial of Adjuvant Pazopanib
Versus Placebo After Nephrectomy in Patients with Locally Advanced
Renal Cell Carcinoma (RCC) (PROTECT) [Abstract #4507; Monday, June
5, 10:12 AM CDT]
- A Phase I/II Study to Assess the Safety and
Efficacy of Pazopanib (PAZ) and Pembrolizumab (PEM) in Patients
(pts) with Advanced Renal Cell Carcinoma (aRCC) [Abstract
#4506; Monday, June 5, 9:36 AM CDT]
Additional data presented at ASCO
include:
-
Phase III Study of Lapatinib (L) Plus
Trastuzumab (T) and Aromatase Inhibitor (AI) vs T+AI vs L+AI in
Postmenopausal Women (PMW) with HER2+, HR+ Metastatic Breast Cancer
(MBC): ALTERNATIVE [Abstract #1004; Saturday, June 3, 2:27 PM
CDT]
-
Everolimus (EVE) Plus Endocrine Therapy in
Patients with Estrogen Receptor-Positive (ER+), Human Epidermal
Growth Factor Receptor 2-Negative (HER2-) Advanced Breast Cancer
(BC): First and Second-Line Data from the BOLERO-4 Study [Abstract
#1010; Sunday, June 4, 8:00 AM CDT]
-
Cognitive Technology Addressing Optimal Cancer
Clinical Trial Matching and Protocol Feasibility in a Community
Cancer Practice [Abstract #6501; Monday, June 5, 8:12 AM
CDT]
Sandoz, a Novartis division, the
pioneer and global leader in biosimilars, will present data for
Zarxio®, the
company's filgrastim biosimilar:
-
Safety and Efficacy of Alternating Treatment
with EP2006, a Filgrastim Biosimilar, and Reference Filgrastim for
the Prevention of Severe Neutropenia, in Patients with Breast
Cancer Receiving Myelosuppressive Chemotherapy [Abstract #10116;
Saturday, June 3, 1:15 PM CDT]
Novartis data at
the 14th Meeting of
ICML will highlight data from the multi-center Phase II JULIET
study evaluating the efficacy and safety of CTL019 in adult
patients with r/r diffuse large B-cell lymphoma (DLBCL):
-
Global Pivotal Phase 2 Trial of the
CD19-Targeted Therapy CTL019 in Adult Patients with Relapsed or
Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) - An Interim
Analysis [Abstract #007; Wednesday, June 14, 3:40 PM CEST]
Novartis data at the 2017 EHA
Annual Congress will highlight the following:
Data evaluating
CTL019** outcomes in r/r pediatric and young adult patients with
B-ALL:
-
Global Registration Trial of Efficacy and Safety
of CTL019 in Pediatric and Young Adult Patients with
Relapsed/Refractory (R/R) Acute Lymphoblastic Leukemia (ALL):
Update to the Interim Analysis [Abstract #S476; Saturday, June 24,
4:00 PM CEST]
-
Analysis of Safety Data from 2 Multicenter
Trials of CTL019 in Pediatric and Young Adult Patients with
Relapsed/Refractory (R/R) B-Cell Acute Lymphoblastic Leukemia
(B-ALL) [Abstract #P517; Saturday, June 24, 5:30 PM CEST]
-
CTL019 Clinical Pharmacology and
Biopharmaceutics in Pediatric Patients (pts) with Relapsed or
Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) [Abstract
#S477; Saturday, June 24, 4:15 PM CEST]
New analyses of
ENESTfreedom and ENESTop evaluating Treatment-free Remission (TFR)
at 96-week follow-up in patients meeting rigorous criteria for
treatment discontinuation:
-
Durable Treatment-free Remission (TFR) After
Stopping Second-line Nilotinib (NIL) in Patients (Pts) with Chronic
Myeloid Leukemia in Chronic Phase (CML-CP): ENESTop 96-Wk Update
[Abstract #P257; Friday, June 23, 5:15 PM CEST]
-
Durable Treatment-free Remission (TFR) Following
Frontline Nilotinib in Patients (Pts) with Chronic Myeloid Leukemia
in Chronic Phase (CML-CP): ENESTfreedom 96-Wk Update [Abstract
#P601; Saturday, June 24, 5:30 PM CEST]
Pooled survival analysis of two
clinical trials evaluating Rydapt® (midostaurin)
in adult patients with advanced systemic mastocytosis:
-
Pooled Survival Analysis of Midostaurin Clinical
Study Data (D2201 + A2213) in Patients with Advanced Systemic
Mastocytosis (ADVSM) Compared with Historical Controls [Abstract
#S788; Sunday, June 25, 9:00 AM CEST]
New data in
myeloproliferative neoplasms, including a long-term analysis
evaluating Jakavi® (ruxolitinib)*** in patients with inadequately
controlled polycythemia vera in a less advanced phase of the
disease:
- Ruxolitinib For The Treatment Of Inadequately
Controlled Polycythemia Vera Without Splenomegaly: 80-Week
Follow-Up From The RESPONSE-2 Trial [Abstract #S784; Sunday, June
25, 8:00 AM CEST]
- Comparing The Safety And Efficacy Of Ruxolitinib
(Rux) In Patients (Pts) With DIPSS Low/Intermediate-1-,
Intermediate-2-, And High-Risk Myelofibrosis (MF) In JUMP, A Phase
3b, Expanded-Access Study [Abstract #E1333; Friday, June 23, 9:30
AM CEST]
- Treatment and Management Of Patients With MPNs -
Findings From the International MPN LANDMARK Survey [Abstract
#P706; Saturday, June 24, 5:30 PM CEST]
- Perception Of Symptom Burden and Treatment Goals
Between Physicians and Patients With MPNs: An Analysis From the
International MPN LANDMARK Survey [Abstract #E1320; Friday, June
23, 9:30 AM CEST]
Additional data presented at EHA
include:
-
Mediation by Patient-Reported Outcomes on the
Association Between Film-Coated versus Dispersible Formulations of
Deferasirox and Serum Ferritin Reduction: A Post-Hoc Analysis of
the ECLIPSE Trial [Abstract #P286; Friday, June 23, 5:15 PM
CEST]
-
Crizanlizumab, a P-selectin Inhibitor, Increases
the Likelihood of Not Experiencing a Sickle Cell-Related Pain
Crisis While on Treatment: Results from the Phase II SUSTAIN Study
[Abstract #S454; Saturday, June 24, 12:15 PM CEST]
Throughout the 2017 ASCO Annual Meeting, ICML meeting and EHA
Annual Meeting, Novartis Oncology will host dedicated content on
the Novartis Oncology 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.
EGF816, CTL019 and crizanlizumab (SEG101, formerly
SelG1) are investigational compounds. Efficacy and safety have not
been established. There is no guarantee these compounds will become
commercially available.
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by words such as "to be presented," "will,"
"upcoming," "excited," "commitment," "invesgitational," "emerging,"
"yet," or similar terms, or by express or implied discussions
regarding potential new indications or labeling for Kisqali,
Tasigna, Tafinlar, Mekinist, Zykadia, Afinitor, Zarxio, Rydapt,
Jakavi or the other products in the Novartis Oncology portfolio,
regarding potential marketing approvals for CTL019, EGF816, SEG101
or the other development compounds in the Novartis Oncology
pipeline, or regarding potential future revenues from such products
and development 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 Kisqali,
Tasigna, Tafinlar, Mekinist, Zykadia, Afinitor, Zarxio, Rydapt,
Jakavi or the other products in the Novartis Oncology portfolio
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 CTL019, EGF816, SEG101 or the other
development compounds in the Novartis Oncology pipeline will be
approved for sale in any market, or at any particular time. Nor can
there be any guarantee that such products and development compounds
will be commercially successful in the future. In particular,
management's expectations regarding such products and development
compounds 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; 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 and reimbursement pressures; 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 118,000 full-time-equivalent
associates. Novartis products are sold in approximately 155
countries around the world. For more information, please visit
http://www.novartis.com.
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* Kisqali was developed by the Novartis Institutes
for BioMedical Research (NIBR) under a research collaboration with
Astex Pharmaceuticals.
** 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.
# # #
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