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Novartis announces longer-term analyses from pivotal Kymriah® trials that showed durable responses are maintained in patients with advanced blood cancers

Novartis International AG /
Novartis announces longer-term analyses from pivotal Kymriah® trials that showed
durable responses are maintained in patients with advanced blood cancers
. Processed and transmitted by West Corporation.
The issuer is solely responsible for the content of this announcement.

* In the updated analysis from ELIANA, Kymriah demonstrated an 82% remission
rate within 3 months in pediatric patients with r/r ALL; relapse-free
survival was 62% at 24 months, with median duration of remission still not
reached[1]

* The longer follow-up from the JULIET study in patients with r/r DLBCL
reported 64% relapse-free probability and a 43% probability of overall
survival at 18 months, with median duration of response still not reached[2]

* The safety profiles observed in both longer-term analyses remained
consistent with previously reported results, with no emergence of new safety
signals

* ASH presentations demonstrate the Novartis commitment to understanding the
long-term potential of Kymriah in transforming the treatment of ALL and
DLBCL

Basel, December 1, 2018 - Novartis today announced longer-term analyses of both
ELIANA and JULIET, the pivotal clinical trials of Kymriah (tisagenlecleucel) in
children and young adult patients with relapsed or refractory (r/r) acute
lymphoblastic leukemia (ALL) and adult patients with r/r diffuse large B-cell
lymphoma (DLBCL), respectively. In these analyses, Kymriah continued to
demonstrate strong efficacy with durable responses and maintained a consistent
and well-characterized safety profile. These data are being presented at the
60(th) American Society of Hematology (ASH) annual meeting. Additionally, today,
the New England Journal of Medicine published online the 14-month results from
JULIET, the study led by the Abramson Cancer Center at the University of
Pennsylvania[3].

"After bringing the first CAR-T cell therapy to patients, Novartis is committed
to continue our pioneering efforts to reimagine the treatment paradigm for
patients with aggressive blood cancer," said Samit Hirawat, MD, Head, Novartis
Oncology Global Drug Development. "These analyses underscore the longer-term
durability of response with Kymriah and its consistent safety profile,
reinforcing our belief in the potential for CAR-T cell therapy to extend the
lives of patients with these advanced B-cell malignancies."

In the 24-month follow-up analysis of the ELIANA study in children and young
adults with r/r B-cell ALL, Kymriah demonstrated deep and durable responses
without subsequent therapy in a significant portion of patients in this
population. Among 79 evaluable patients, who were followed for at least three
months or discontinued earlier, 82% (95% confidence interval [CI], 72% - 90%)
achieved complete response (CR) or CR with incomplete blood count recovery (CRi)
within three months of infusion; and among these responding patients, 98% had
negative minimal residual disease (MRD-). The relapse-free survival rate was
62% at 24 months; and the median duration of remission (mDOR) and median overall
survival (mOS) remained unreached, signifying responses are deep and sustained,
and further reinforcing the potential for Kymriah to be a definitive therapy for
many patients. The probability of OS was 76% (95% CI, 65% - 85%) at 12 months
and 66% (95% CI, 58% - 79%) at 24 months. The safety profile observed in this
updated analysis was consistent with previously reported results, with no
emergence of new safety signals. Grade 3/4 cytokine release syndrome (CRS) - as
defined by the rigorous Penn Grading Scale - occurred in 49% of patients. Within
eight weeks of infusion, 13% of patients experienced grade 3 neurological
events, with no grade 4 events or cerebral edema[1]. These updated data will be
presented in an oral session at the ASH annual meeting (Abstract # 895; Monday,
December 3, 4:30 PM PST).

"Our group has devoted a great deal of attention to advancing treatment options
for children and young adults with B-cell ALL. This two-year analysis is an
exciting milestone for the field, as it is the longest follow-up data for a
multicenter CAR-T cell trial for those patients who have failed to respond to
other treatment options," said Stephan A. Grupp, MD, PhD, Director of the Cancer
Immunotherapy Program and Section Chief of Cell Therapy and Transplant at
Children's Hospital of Philadelphia, and a Professor of Pediatrics in the
Perelman School of Medicine at the University of Pennsylvania. "Seeing that the
majority of responding patients from ELIANA are still in remission for this long
after a one-time infusion further establishes Kymriah as a truly transformative
treatment option."

The 19-month analysis from the JULIET study of Kymriah in adult patients with
r/r DLBCL showed prolonged durability of response in patients (n=99) who had
previously been through multiple rounds of chemotherapy and unsuccessful stem
cell transplants. The overall response rate (ORR) after a median of 19 months of
follow-up was 54% (95% CI, 43% - 64%; CR, 40%; partial response [PR], 13%) among
patients who were followed for at least 3 months or discontinued earlier. The
mDOR was not reached at the time of analysis indicating most responders were
still experiencing a response at the time of analysis; and the relapse-free
probability, which was 66% (95% CI, 51%-78%) at 6 months, remained consistent at
64% (95% CI, 48%-76%) between 12-month and 18-month analyses. Further, 54%
(15/28) of patients who had achieved a PR converted to CR. Median OS for all
infused patients was 11.1 months (95% CI, 6.6 months-NE) and not reached (95%
CI, 21 months-NE) for patients in CR. The OS probability was 48% (95% CI,
38%-57%) at 12 months and 43% (95%CI, 33%-53%) at 18 months (max follow-up, 29
months). Analyses of ORR, DOR and OS data showed consistent results across all
patient subgroups, regardless of relapsed/refractory status, age and high-risk
cytogenetics.

The safety profile observed in the 19-month follow-up from JULIET continued to
be consistent with previous reports and no deaths occurred due to causes other
than disease progression in this longer-term follow up analysis. Within eight
weeks of infusion with Kymriah, Grade 3/4 CRS, as defined by the Penn Grading
Scale, was reported in 23% of patients. CRS management was conducted per the
Penn CRS management algorithm, which is specific to Kymriah. Tocilizumab and
steroids were used in 16% and 11% of patients, respectively, to treat CRS.
Eleven percent of patients had Grade 3/4 neurologic adverse events, which were
managed with supportive care[2].

The updated JULIET data will be presented today in a poster at the ASH annual
meeting (Abstract #1684; Saturday, December 1, 6:15 PM PST).

"Before CAR-T cell therapy, achieving and maintaining a prolonged complete
response in adult patients with relapsed or refractory DLBCL was incredibly
rare, but now we are seeing Kymriah result in durable complete responses more
than a year and a half after infusion[4]," said lead author of the updated
JULIET analysis, Stephen J. Schuster, MD, the Robert and Margarita Louis-Dreyfus
Professor in Chronic Lymphocytic Leukemia and Lymphoma Clinical Care and
Research in the University of Pennsylvania's (Penn) Perelman School of Medicine
and director of the Lymphoma Program at the Abramson Cancer Center. "For
physicians treating this patient population, duration of response and a
consistent safety profile are incredibly important data points, and the findings
from this updated analysis further instill confidence in the continuing
potential of Kymriah in the treatment of these patients."

Kymriah is approved in the US, the EU, Canada and Switzerland for children and
young adults with relapsed or refractory ALL and in adult patients with relapsed
or refractory DLBCL, making it the only CAR-T cell therapy approved for two
distinct indications and delivering the transformative potential for durable
responses for patients who relapse or don't respond to initial therapies and for
whom the outlook is poor. Patients do not need to be in complete remission to
receive Kymriah and no donor is required.

About the ELIANA Trial
ELIANA is the first pediatric global CAR-T cell therapy registration trial,
examining patients in 25 centers in 11 countries across the US, Canada,
Australia, Japan and the EU, including: Austria, Belgium, France, Germany,
Italy, Norway and Spain, demonstrating effective distribution of Kymriah across
four continents using a global supply chain. In 2012, Novartis and Penn entered
into a global collaboration to further research, develop and commercialize CAR-T
cell therapies, including Kymriah, for the investigational treatment of cancers.

About the JULIET Trial
JULIET is the first multi-center global registration study for Kymriah in adult
patients with r/r DLBCL. JULIET, led by researchers at the University of
Pennsylvania, is the largest and only registration study examining a CAR-T cell
therapy in DLBCL, enrolling patients from 27 sites in 10 countries across the
US, Canada, Australia, Japan and Europe, including Austria, France, Germany,
Italy, Norway and the Netherlands.

Kymriah(®) (tisagenlecleucel, formerly CTL019) US Important Safety information
Kymriah may cause side effects that are severe or life-threatening, such as
Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients with CRS
may experience symptoms including difficulty breathing, fever (100.4°F/38°C or
higher), chills/shaking chills, severe nausea, vomiting and diarrhea, severe
muscle or joint pain, very low blood pressure, or dizziness/lightheadedness.
Patients may be admitted to the hospital for CRS and treated with other
medications.

Patients with neurological toxicities may experience symptoms such as altered or
decreased consciousness, headaches, delirium, confusion, agitation, anxiety,
seizures, difficulty speaking and understanding, or loss of balance. Patients
should be advised to call their healthcare provider or get emergency help right
away if they experience any of these signs and symptoms of CRS or neurological
toxicities.

Because of the risk of CRS and neurological toxicities, Kymriah is only
available through a restricted program under a Risk Evaluation and Mitigation
Strategy (REMS) called Kymriah REMS.

Serious allergic reactions, including anaphylaxis, may occur after Kymriah
infusion. Kymriah can increase the risk of life-threatening infections that may
lead to death. Patients should be advised to tell their healthcare provider
right away if they develop fever, chills, or any signs or symptoms of an
infection.

Patients may experience prolonged low blood cell counts (cytopenia), where one
or more types of blood cells (red blood cells, white blood cells, or platelets)
are decreased. The patient's healthcare provider will do blood tests to check
all of their blood cell counts after treatment with Kymriah. Patients should be
advised to tell their healthcare provider right away if they get a fever, are
feeling tired, or have bruising or bleeding.

Patients may experience hypogammaglobulinemia, a condition in which the level of
immunoglobulins (antibodies) in the blood is low and the risk of infection is
increased. It is expected that patients may develop hypogammaglobulinemia with
Kymriah, and may need to receive immunoglobulin replacement for an indefinite
amount of time following treatment with Kymriah. Patients should tell their
healthcare provider about their treatment with Kymriah before receiving a live
virus vaccine.

After treatment with Kymriah, patients will be monitored lifelong by their
healthcare provider, as they may develop secondary cancers or recurrence of
their cancer.

Patients should not drive, operate heavy machinery, or do other dangerous
activities for eight weeks after receiving Kymriah because the treatment can
cause temporary memory and coordination problems, including sleepiness,
confusion, weakness, dizziness, and seizures.

Some of the most common side effects of Kymriah are difficulty breathing, fever
(100.4°F/38°C or higher), chills/shaking chills, confusion, severe nausea,
vomiting and diarrhea, severe muscle or joint pain, very low blood pressure,
dizziness/lightheadedness, and headache. However, these are not all of the
possible side effects of Kymriah. Patients should talk to their healthcare
provider for medical advice about side effects.

Prior to a female patient starting treatment with Kymriah, their healthcare
provider may do a pregnancy test. There is no information available for Kymriah
use in pregnant or breast-feeding women. Therefore, Kymriah is not recommended
for women who are pregnant or breast feeding. Patients should talk to their
healthcare provider about birth control and pregnancy.

Patients should tell their healthcare provider about all the medicines they
take, including prescription and over-the-counter medicines, vitamins, and
herbal supplements.

After receiving Kymriah, patients should be advised that some commercial HIV
tests may cause a false-positive test result. Patients should also be advised
not to donate blood, organs, or tissues and cells for transplantation after
receiving Kymriah.

Please see the full Prescribing Information for Kymriah, including Boxed
WARNING, and Medication Guide at www.Kymriah.com

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; global trends toward health care cost
containment, including government, payor and general public pricing and
reimbursement pressures; our ability to obtain or maintain proprietary
intellectual property protection; the particular prescribing preferences of
physicians and patients; general political and economic conditions; safety,
quality or manufacturing issues; potential or actual data security and data
privacy breaches, or disruptions of our information technology systems, 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 is reimagining medicine to improve and extend people's lives. As a
leading global medicines company, we use innovative science and digital
technologies to create transformative treatments in areas of great medical need.
In our quest to find new medicines, we consistently rank among the world's top
companies investing in research and development. Novartis products reach nearly
1 billion people globally and we are finding innovative ways to expand access to
our latest treatments. About 125 000 people of more than 140 nationalities work
at Novartis around the world. Find out more at www.novartis.com.

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

References
[1]    Grupp S., et al. Updated Analysis of the Efficacy and Safety of
Tisagenlecleucel in Pediatric and Young Adult Patients with Relapsed/Refractory
(r/r) Acute Lymphoblastic Leukemia. 60(th) American Society of Hematology Annual
Meeting and Exposition. Abstract #112599.
[2]    Schuster S., et al. Sustained Disease Control for Adult Patients with
Relapsed or Refractory Diffuse Large B-Cell Lymphoma: An Updated Analysis of
Juliet, a Global Pivotal Phase 2 Trial of Tisagenlecleucel, Acute Lymphoblastic
Leukemia. 60(th) American Society of Hematology Annual Meeting and Exposition.
Abstract #11525.
[3]    Schuster S., et al. Tisagenlecleucel in Adult Relapsed/Refractory Diffuse
Large B-Cell Lymphoma. N Engl J Med. December 2018.
[4]    Van Den Neste E., et al. Outcome of patients with relapsed diffuse large
B-cell lymphoma who fail second-line salvage regimens in the International CORAL
study. Bone Marrow Transplant. January 2016.

# # #

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

Eric Althoff Fiona Phillips
Novartis Global Media Relations Novartis Oncology Communications
+41 61 324 7999 (direct) +1 862-778-7705 (direct)
+41 79 593 4202 (mobile) +1 862-217-9396 (mobile)
eric.althoff@novartis.com fiona.phillips@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 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/2227522/874527.pdf



This announcement is distributed by West Corporation on behalf of West Corporation 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



 
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