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Press Release: Novartis Kymriah(R) demonstrates -2-

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*DJ Novartis Kymriah(R) demonstrates consistent efficacy and safety outcomes in US patients when used in real-world setting

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December 09, 2019 14:45 ET ( 19:45 GMT)

Press Release: Novartis Kymriah(R) demonstrates consistent efficacy and safety outcomes in US patients when used in real-world setting



Efficacy in DLBCL confirmed results seen in the pivotal trial despite
treatment of a broader population, including older and more heavily
pretreated patients1-3

Fewer known CAR-T cell therapy adverse events for patients with DLBCL,
specifically rates of high-grade cytokine release syndrome (4%) and
neurologic events (5%), were observed compared with the pivotal clinical
trials1-3

In children and young adults with ALL, efficacy outcomes were similar and
safety outcomes appear to be more favorable compared to the pivotal
trial4

Understanding the Kymriah safety profile, and increased experience with
administration in real-world practice supports use in the outpatient
setting


Basel, December 9, 2019 Novartis today announced results from two
analyses of real-world experience with Kymriah(R) (tisagenlecleucel),
the only CAR-T cell therapy approved in two distinct indications. These
analyses are from a readout of a 15-year post-marketing study that add
to and complement the rigor of the Kymriah pivotal trials with evidence
of the Kymriah real-world experience in expanded groups of patients.
When Kymriah was used in the real-world setting, efficacy and safety
were consistent when compared to the pivotal trials, including the
24-month analysis of JULIET in adults with r/r diffuse large B cell
lymphoma (DLBCL) and ELIANA in children and young adults with r/r B-cell
acute lymphoblastic leukemia (ALL)(1-6) . The real-world experience data
were presented at the 61st American Society of Hematology (ASH) annual
meeting.

"With increased experience supplemented by real world data, physicians
like myself have a better understanding of Kymriah and its safety
profile," said lead author of this real-world experience analysis,
Samantha Jaglowski, MD, The Ohio State University Comprehensive Cancer
Center Arthur G. James Cancer Hospital and Richard J. Solove Research
Institute (OSUCCC James). "This along with the current practice of
supportive care for CAR-T therapy provides the ability to routinely use
this therapy in the hospital outpatient setting, which can reduce
financial burden on patients and hospitals alike(1,7) ."

Real-world experience with Kymriah in adults with r/r DLBCL

Efficacy

Efficacy outcomes for patients who received Kymriah in the real-world
setting were similar to those demonstrated in JULIET. In this analysis
of 80 patients with r/r DLBCL for whom three or more months of
post-infusion outcomes were available, the overall response rate (ORR)
was 58% including 40% who achieved a complete response (CR). Median
follow-up was 4.5 months(1) . In the 24-month analysis of the JULIET
trial, ORR was 52% and CR was 38% (N=115) (3) .

Safety

The anticipation and management of adverse events of CAR-T cell therapy
have been crucial to successful administration of this innovative and
relatively new type of therapy. In this analysis of real-world
experience with Kymriah (safety set, N=83), the rate of grade 3 or
higher cytokine release syndrome (CRS) and neurologic events were
approximately 4% and 5%, respectively, as compared to 23% and 11% in the
JULIET clinical trial (safety set, N=115), suggesting safety outcomes
appear more favorable. The real-world analysis used the grading scales
ASTCT for CRS and ICANs for neurologic events, whereas the JULIET trial
used the Penn Grading Scale for CRS and MedDRA SMQ for neurologic
events(1,3) .

Further, for patients who had CRS, tocilizumab and corticosteroids were
administered in 20% and 4% of patients, respectively, in the real-world
setting, and in 27% and 19% of patients, respectively, in the JULIET
trial(8) . Some patients in the real-world setting received tocilizumab
earlier than in the clinical trial experience, indicating earlier use of
supportive care may mitigate rates of high-grade CRS(9) . A total of 14
DLBCL patients died after treatment, all due to disease progression,
however no deaths were attributed to toxicities from Kymriah(1) .

Patient and product characteristics

More patients in the real-word analysis had a worse performance status,
and on average, these patients were older and had received more lines of
therapy than those treated in the JULIET trial(1-3) .

Cell viability is one of many product release specifications for
Kymriah. The commercial specification for the viability specification of
Kymriah in the United States is set at greater than or equal to 80%. For
all other markets where KYMRIAH is approved, the cell viability
specification is greater than or equal to 70%. In this US real-world
analysis, 29 of the 102 patients with evaluable data received product
that was below 80% cell viability. Efficacy and safety for patients
receiving product with cell viability below the commercial specification
was the same as those receiving commercial Kymriah(1) .

These data on the use of Kymriah in r/r DLBCL in the real-world setting
will be presented in an oral session at the ASH annual meeting (Abstract
# 766; Monday, December 9, 3:30 PM EST).

"As pioneers in bringing CAR-T cell therapy to patients, our dedication
to reimagining how CAR-T cell therapy can impact patients in the future
remains steadfast," said Susanne Schaffert, PhD, President, Novartis
Oncology. "Our efforts include gathering and sharing real-world evidence,
expanding and improving our manufacturing capacity and technology and
going broader and deeper in our clinical research with Kymriah and other
CAR-T cell therapies."

Real-world experience with Kymriah in children and young adults with r/r
ALL

Efficacy outcomes were similar and safety outcomes appear to be more
favorable in the real world setting compared to the ELIANA pivotal
trial(4-6) . Among 146 children and young adult patients with r/r ALL
treated in the real world setting for whom three or more months of
post-infusion outcomes were available, CR was 85% as compared to 82% in
the ELIANA trial (n=79). Median follow-up in the real-world analysis was
6 months. In this analysis (safety set, N=154), the rate of grade 3 or
higher CRS and neurologic events were 14% and 8%, respectively, as
compared to 48% and 13% in the ELIANA clinical trial. The real-world
analysis used the grading scales ASTCT for CRS and ICANs for neurologic
events, whereas the ELIANA trial used the Penn Grading Scale for CRS and
MedDRA SMQ for neurologic events(4-6) .

"It is exciting to see how oncologists are using Kymriah and how
patients are responding to it in routine clinical practice," 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. "We are seeing broader
efficacy data that replicate what we saw in the pivotal trial, and the
collection of these data is ensuring that we are getting a clear view of
adverse events when administering Kymriah."

These data on the use of Kymriah in r/r pediatric ALL in the real-world
setting will be presented in a poster presentation at the ASH annual
meeting (Abstract #2619; Sunday, December 8, 6:00 8:00 PM EST).

The collection of this real-world experience data was made possible by a
collaboration between the CIBMTR(R) (Center for International Blood and
Marrow Transplant Research the research collaboration between the
National Marrow Donor Program(R) /Be The Match(R) and the Medical
College of Wisconsin) and Novartis, developed to capture long-term
follow-up of recipients of Kymriah who agree to participate in the
registry. For patients whose cell viability was below 80%, product is
provided through an established EAP program and long-term follow-up is
captured through the CIBMTR. Globally, 90% patients who have been
prescribed Kymriah have received the final manufactured product, either
commercially, or when out of commercial specification.

Kymriah(R) (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
(100.4degF/38degC 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.


(MORE TO FOLLOW) Dow Jones Newswires

December 09, 2019 14:45 ET ( 19:45 GMT)


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 (100.4degF/38degC 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 and requirements for increased pricing transparency; 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 more than 750 million people
globally and we are finding innovative ways to expand access to our
latest treatments. About 109,000 people of more than 140 nationalities
work at Novartis around the world. Find out more at

www.novartis.com.

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References

1. Jaglowski S., et al. Tisagenlecleucel Chimeric Antigen Receptor
(CAR) T-Cell Therapy for Adults with Diffuse Large B-Cell Lymphoma
(DLBCL): Real World Experience from the Center for International Blood &
Marrow Transplant Research (CIBMTR) Cellular Therapy (CT) Registry
[abstract]. In: The 61st ASH Annual Meeting.; December 7-10; Orlando,
Florida.

2. Schuster S.., et al. Tisagenlecleucel in Adult Relapsed/Refractory
Diffuse Large B-Cell Lymphoma. N Engl J Med. December 2018

3. Bachanova V., et. al. Correlative Analyses of Cytokine Release
Syndrome and Neurological Events in Tisagenlecleucel-Treated
Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients. ICML 2019
abstract #254

4. Grupp S., et al. Tisagenlecleucel Chimeric Antigen Receptor (CAR)
T-Cell Therapy for Relapsed/Refractory Children and Young Adults with
Acute Lymphoblastic Leukemia (ALL): Real World Experience from the
Center for International Blood & Marrow Transplant Research (CIBMTR)
Cellular Therapy (CT) Registry [abstract]. In: The 61st ASH Annual
Meeting.; December 7-10; Orlando, Florida.

5. Maude S., et al. Tisagenlecleucel in children and young adults with
B-cell lymphoblastic leukemia. N Engl J Med. 2018;378(5):43948

6. 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. 60th American
Society of Hematology Annual Meeting and Exposition. Abstract #112599.

7. Broder M., et al. Economic Burden of Neurologic Toxicities
Associated with Treating Relapsed or Refractory Diffuse Large B-Cell
Lymphoma in the United States [abstract]. In: The 61th ASH Annual
Meeting.; December 7-10; Orlando, Florida.

8. Schuster S.., et al. Consensus Grading of Cytokine Release Syndrome
(CRS) in Adult Patients with Relapsed or Refractory Diffuse Large B-Cell
Lymphoma (r/r DLBCL) Treated with Tisagenlecleucel on the JULIET Study.
Poster #4190

9. Novartis Data on file.

# # #

Novartis Media Relations

E-mail: media.relations@novartis.com




Antonio Ligi Fiona Phillips
Novartis External Communications Novartis Oncology Communications
+41 61 324 13 74 +1 862 778-7705 (direct)
antonio.ligi@novartis.com +1 862-217-9396 (mobile)
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Novartis US External Communications
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eric.althoff@novartis.com

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@novartis.com




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(END) Dow Jones Newswires

December 09, 2019 14:45 ET ( 19:45 GMT)
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