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Novartis : presents results from first global registration trial of CTL019 in pediatric and young adult patients with r/r B-ALL

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12/04/2016 | 01:01am CET
Novartis International AG /
Novartis presents results from first global registration trial of CTL019 in 
pediatric and young adult patients with r/r B-ALL 
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement. 

  * 82% (41 of 50) of patients achieved complete remission or complete remission
    with incomplete blood count recovery in interim analysis of Novartis study

  * ELIANA, the first global CAR T cell trial, will be the basis of a Biologics
    Licensing Application (BLA) to the FDA in early 2017

  * Novartis pivotal data from ELIANA is supported by CTL019 US multicenter
    trial (ENSIGN) as well as earlier single site trial in r/r pediatric and
    young adult patients with B-cell ALL

  * The University of Pennsylvania (Penn) will present findings evaluating
    overall response to CTL019 therapy among r/r DLBCL patients with poor

Basel, December 4, 2016 - Findings from a Novartis clinical trial (ELIANA)
evaluating efficacy and safety of CTL019, an investigational chimeric antigen
receptor T cell (CAR T) therapy, in relapsed/refractory (r/r) pediatric and
young adult patients with B-cell acute lymphoblastic leukemia (ALL) will be
presented today during an oral session at the 58th American Society of
Hematology (ASH) annual meeting (Abstract #221, December 3, 4:00-5:30 p.m.). The
global Phase II study found that 82% (41 of 50) of infused patients achieved
complete remission or complete remission with incomplete blood count recovery at
three months post CTL019 infusion. For all patients with complete remission, no
minimal residual disease was detected. In addition, the estimated relapse-free
rate among responders was 60% (95% CI: 36, 78) six months after infusion with
CTL019.[1] The results set the stage for filing CTL019 with the US Food and Drug
Administration (FDA) in early 2017 for pediatric and young adult patients with
r/r B-cell ALL.

ELIANA is the first pediatric global CAR T cell registration trial with study
enrollment having occurred across 25 centers in the US, EU, Canada, Australia
and Japan. Forty-eight percent of patients in ELIANA experienced grade 3 or 4
cytokine release syndrome (CRS), a known complication of the investigational
therapy that may occur when the engineered cells become activated in the
patient's body. CRS was managed on a global scale using prior site education
with implementation of the CRS treatment algorithm. There were no deaths due to
CRS. Fifteen percent of patients experienced grade 3 neurological and
psychiatric events including encephalopathy and delirium, with no grade 4 events

"These global multicenter trial data build on earlier encouraging research
conducted at a single trial site, and advance the case for CTL019 as a potential
treatment for children and young adults with relapsed or refractory B-cell ALL,"
said lead investigator Stephan Grupp, MD, PhD, the Yetta Deitch Novotny
Professor of Pediatrics at the Perelman School of Medicine at the University of
Pennsylvania (Penn), and Director of the Cancer Immunotherapy Frontier Program
at the Children's Hospital of Philadelphia (CHOP).

In addition to filing CTL019 for approval with the FDA in early 2017, Novartis
plans to file with the European Medicines Agency (EMA) later in 2017. The
investigational therapy received PRIME (PRIority MEdicines) designation from the
EMA earlier this year.

"This first-of-its-kind trial represents exciting progress toward our goal of
helping children and young adults with relapsed or refractory B-cell ALL, a
patient population with an urgent need for new treatment options," said Bruno
Strigini, CEO, Novartis Oncology. "We are committed to advancing CTL019 and look
forward to working closely with the FDA and EMA in the coming months."

Dr. Shannon Maude from CHOP will give a poster presentation highlighting data
from ENSIGN, the first US multicenter Phase II trial for CTL019 in pediatric and
young adults with B-cell ALL (Abstract #2801, December 4, 6:00-8:00 p.m.).[2] A
separate poster presentation will also highlight an ongoing Phase IIa study led
by Penn which investigated the efficacy and safety of CTL019 in poor prognostic
groups of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients
(Abstract #3026, December 4, 6:00-8:00 p.m.).[3]

Because CTL019 is an investigational therapy, the safety and efficacy profile
has not yet been established. Access to investigational therapies is available
only through carefully controlled and monitored clinical trials. These trials
are designed to better understand the potential benefits and risks of the
therapy. Because of uncertainty of clinical trials, there is no guarantee that
CTL019 will ever be commercially available anywhere in the world.

The foregoing release contains forward-looking statements that can be identified
by words such as "will," "investigational," "build on," "encouraging," "advance
the case," "potential," "exciting," "goal," "committed," "look forward," "yet,"
or similar terms, or by express or implied discussions regarding potential
marketing approvals for CTL019, or regarding potential future revenues from
CTL019. 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 CTL019 will be submitted or approved
for sale in any market, or at any particular time. Nor can there be any
guarantee that CTL019 will be commercially successful in the future. In
particular, management's expectations regarding CTL019 could be affected by,
among other things, the uncertainties inherent in research and development,
including unexpected clinical trial results and additional analysis of existing
clinical data; unexpected 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 pressures;
unexpected 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,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in
approximately 180 countries around the world. For more information, please visit

Novartis is on Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis and @NovartisCancer at
For Novartis multimedia content, please visit www.novartis.com/news/media-
For questions about the site or required registration, please contact

[1] Grupp, Stephen A. et al. 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). Session 614, Saturday,
December 3, 5:00 p.m. PST. 58(th) American Society of Hematology Annual Meeting
and Exposition: Abstract 221.
[2] Maude, Shannon L. et al. 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. Session 614, Sunday, December 4, 6:00
- 8:00 p.m. PST. 58(th) American Society of Hematology Annual Meeting and
Exposition: Abstract 2801.
[3] Schuster, Stephen J. et al. 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. Session
626, Sunday, December 4, 6:00 - 8:00 pm PST. 58(th) American Society of
Hematology Annual Meeting and Exposition: Abstract 3026.

                                     # # #

Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com

  Eric Althoff                      Heather Bochner
  Novartis Global Media Relations   Novartis Oncology
  +41 61 324 7999 (direct)          +1 862-778-5092 (direct)
  +41 79 593 4202 (mobile)          +1 862-432-8472 (mobile)
  eric.althoff@novartis.com         heather.bochner@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

  Central                                   North America

  Samir Shah              +41 61 324 7944   Richard Pulik   +1 212 830 2448

  Pierre-Michel Bringer   +41 61 324 1065   Sloan Pavsner   +1 212 830 2417

  Thomas Hungerbuehler    +41 61 324 8425

  Isabella Zinck          +41 61 324 7188

Media release (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

 --- End of Message --- 

Novartis International AG
P.O. Box Basel Switzerland

WKN: 904278;ISIN: CH0012005267; 

© Thomson Reuters, source European Press Releases

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Sales 2016 48 805 M
EBIT 2016 11 856 M
Net income 2016 7 810 M
Debt 2016 15 084 M
Yield 2016 4,16%
P/E ratio 2016 19,70
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EV / Sales 2016 3,97x
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Capitalization 178 737 M
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Joseph Jimenez Chief Executive Officer
Hans Jörg Reinhardt Independent Non-Executive Chairman
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