-- At final analysis, study showed clinically relevant improvement in median 
      overall survival with a difference of 11.7 months between arms (Hazard 
      ratio (HR): 0.84 with 95% CI: (0.60, 1.17) (p=0.30, two-sided))1 
 
 
   -- No new safety signals emerged in long-term follow-up with median of 6.3 
      years; safety profile consistent with previously reported results1 
 
 
   -- Previously reported primary analysis demonstrated statistically 
      significant improvement in progression free survival2 
 
 
   -- Novartis is committed to reimagining cancer through radioligand therapy 
      with more than 15 dedicated research and discovery programs; recent 
      investments and partnerships further strengthen platform capabilities 
 
 
   Basel, June 3, 2021 -- Novartis today reported the final analysis from 
the NETTER-1 phase III study comparing treatment using Lutathera(R) 
(INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) 
plus 30 mg octreotide LAR to 60 mg of octreotide LAR in patients with 
midgut neuroendocrine tumors. The previously reported primary analysis 
of the trial demonstrated a statistically significant improvement in 
progression free survival (PFS) (HR: 0.18*, p < 0.0001)(3) . In the 
final analysis of overall survival, a secondary objective of the trial, 
treatment with Lutathera resulted in a clinically relevant prolongation 
in median overall survival of 11.7 months [48.0 months (95%CI: 
37.4-55.2) compared to the control arm (36.3 months (95%CI: 
25.9-51.7)](1.) While this analysis did not reach statistical 
significance (Hazard ratio for OS (HR): 0.84 with 95% CI: (0.60, 1.17) 
(p=0.30, two-sided))(1) , the analyses of overall survival may have been 
impacted by multiple factors, including the crossover of patients from 
the control arm receiving subsequent radioligand therapy (36% of 
patients) as well as heterogenous subsequent anti-cancer treatments in 
both study arms(1) . No new safety signals emerged in the final 
analysis(1) . These results will be presented during the 2021 American 
Society of Clinical Oncology (ASCO) Annual Meeting on June 4. 
 
   Jonathan Strosberg, MD, Principal Investigator and Associate Professor, 
Section Head, Neuroendocrine Tumor Program at Moffitt Cancer Center, 
said, "Lutathera plus long-acting octreotide was associated with a 
nearly 12-month difference in median overall survival compared to 
high-dose long-acting octreotide in these difficult to treat patients 
with inoperable midgut NETs progressing under standard dose octreotide 
LAR treatment. While not statistically significant, I consider this 
difference to be clinically relevant for these patients. It is also 
important to emphasize that PFS was the primary endpoint of this study. 
Moreover, 36% of patients in the control arm crossed over to receive 
subsequent radioligand treatment, which may have impacted the comparison 
of survival between both study arms." 
 
   "We are proud of our 30-year legacy as an innovator for patients in the 
neuroendocrine tumor community," said John Tsai, Head of Global Drug 
Development and Chief Medical Officer for Novartis. "Since its approval 
by the European Commission in 2017 and the FDA in 2018, Lutathera has 
been administered to more than 9,000 gastroenteropancreatic 
neuroendocrine tumor (GEP-NET) patients in Europe and the United 
States(1) . We believe in the potential of targeted radioligand therapy 
and are investing in new discovery and expansion of this important 
platform, including exploration of new radioisotopes and combinations 
with complementary mechanisms of action, such as immunotherapy and 
inhibitors of DNA damage response." 
 
   At this final analysis, no new safety signals emerged in the long-term 
safety follow-up with a median of 6.3 years. In terms of secondary 
hematological malignancies, no new cases of MDS or acute leukemia were 
reported in the long term follow up(4) . 
 
   Radioligand therapy combines a targeting compound that binds to 
receptors expressed by tumors and a radioactive isotope, causing DNA 
damage that inhibits tumor growth and replication and may lead to cell 
death(5) (-) (7) . In the case of Lutathera, it binds to somatostatin 
receptor type 2, which is over-expressed on certain types of cells, such 
as gastroenteropancreatic neuroendocrine tumor cells(8,9) . 
 
   Novartis has established global expertise and specialized supply chain 
and manufacturing capabilities across its network of four radioligand 
therapy production sites, and is further increasing capacity to ensure 
delivery of future targeted radioligand therapies to patients in need. 
Novartis is the only pharmaceutical company which is pursuing four 
different cancer treatment platforms. These include targeted radioligand 
therapy, cell and gene therapy, targeted therapy and immunotherapy, with 
an opportunity to combine these platforms for the best outcomes for each 
cancer patient. 
 
   Visit https://www.hcp.novartis.com/virtual-congress/a-2021/ for the 
latest information from Novartis, including our commitment to the 
Oncology community, and access to our ASCO21 Virtual Scientific Program 
data presentations (for registered participants). 
 
   * HR: 0.21 (0.13, 0.32) in the US Package Insert 
 
   About NETTER-1 
 
   NETTER-1 is a Phase III international, multicenter, controlled, 
randomized study that compared treatment using Lutathera(R) every eight 
weeks plus best standard of care (octreotide LAR 30 mg) to 60 mg of 
octreotide LAR (dosed every four weeks) in patients with inoperable 
midgut NETs progressing under standard dose octreotide LAR treatment and 
overexpressing somatostatin receptors(3) . 
 
   The primary endpoint was to compare the progression-free survival (PFS) 
after treatment with Lutathera(R) plus octreotide LAR 30 mg versus 
octreotide LAR 60 mg using RECIST 1.1 criteria(3) . Secondary trial 
endpoints included comparing objective response rate, overall survival, 
time to tumor progression, duration of response and safety between the 
two study arms(3) . 
 
   About GEP-NETs 
 
   Neuroendocrine tumors (NETs) are a type of cancer that originate in 
neuroendocrine cells throughout the body. NETs are commonly considered 
slow-growing malignancies. However, some NETs are associated with rapid 
progression and poor prognosis(1) (0-11) . In many cases, NET diagnosis 
is delayed until patients have advanced disease(12) . Symptoms such as 
fatigue, diarrhea, and abdominal pain can occur on a daily basis(1) (3) 
. Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are subdivided 
into two categories: tumors of the gastrointestinal (GI) tract and 
pancreas(1) (4) . There is a need for additional treatment options for 
inoperable or advanced GEP-NET, including those who have progressed 
while taking first-line somatostatin analogs. 
 
   The estimated age-adjusted incidence, or rate of new cases of NETs in 
the United States is approximately 6.98/100,000 per year (as of 2012), 
while the estimated 20-year limited-duration prevalence for 2014, based 
on the National Cancer Institute's Surveillance, Epidemiology, and End 
Results (SEER) database, was 171,321(11) . Even though NETs have 
historically been considered to be rare (orphan disease), their 
incidence has grown over 500% over the last 3 decades (10) (,) (11) (,) 
(12) (,) (1) (5) . 
 
   About Lutathera(R) 
 
   Lutathera(R) (lutetium Lu 177 dotatate) is an Advanced Accelerator 
Applications product approved in the United States for the treatment of 
somatostatin receptor-positive gastroenteropancreatic neuroendocrine 
tumors (GEP-NETs), including foregut, midgut and hindgut neuroendocrine 
tumors in adults(1) (6) . 
 
   Lutathera(R) (lutetium ((177) Lu) oxodotreotide) is also approved in 
Europe for the treatment of unresectable or metastatic, progressive, 
well differentiated (G1 and G2), somatostatin receptor positive 
gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults(3) . 
 
   Important Safety Information 
 
   LUTATHERA(R) (lutetium Lu 177 dotatate) is a prescription medicine used 
to treat adults with a type of cancer known as gastroenteropancreatic 
neuroendocrine tumors (GEP-NETs) that are positive for the hormone 
receptor somatostatin, including GEP-NETs in the foregut, midgut, and 
hindgut. 
 
   LUTATHERA is associated with some serious safety considerations, and in 
some cases these may require a healthcare provider to adjust or stop 
treatment. Treatment with LUTATHERA will expose patients to radiation 
which can contribute to long-term radiation exposure. Overall radiation 
exposure is associated with an increased risk for cancer. The radiation 
will be detectable in urine for up to 30 days following administration 
of the drug. It is important to minimize radiation exposure to household 
contacts consistent with good radiation safety practices as advised by 
your healthcare provider. Treatment with LUTATHERA increases the risk of 
myelosuppression, a condition in which bone marrow activity is decreased, 
resulting in a drop in blood cell counts. You may experience 
blood-related side effects such as low red blood cells (anemia), low 
numbers of cells that are responsible for blood clotting 
(thrombocytopenia), and low numbers of white blood cells (neutropenia). 
Speak with your healthcare provider if you experience any signs or 
symptoms of infection, fever, chills, dizziness, shortness of breath or 
increased bleeding or bruising. Other serious conditions that you may 
develop as a direct result of treatment with LUTATHERA include blood and 
bone marrow disorders known as secondary myelodysplastic syndrome and 
cancer known as acute leukemia. Your healthcare provider will routinely 
check your blood cell counts and tell you if they are too low or too 
high. Treatment with LUTATHERA will expose kidneys to radiation and may 
impair their ability to work as normal. You may be at an increased risk 
for kidney problems after LUTATHERA treatment if you already have kidney 
impairment before treatment. In some cases, patients have experienced

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