UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 or 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
Report on Form 6-K dated March 9, 2021
(Commission File No. 1-15024)
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Novartis AG
(Name of Registrant)
Lichtstrasse 35
4056 Basel
Switzerland
(Address of Principal Executive Offices)
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Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F:
Form 20-F: ☒
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Form 40-F: ☐
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):
Indicate by check mark whether the registrant by furnishing the information contained
in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
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Novartis International AG
Novartis Global Communications
CH-4002 Basel
Switzerland
http://www.novartis.com
https://twitter.com/novartisnews
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MEDIA & INVESTOR RELEASE
Novartis provides update on
Phase III study evaluating canakinumab (ACZ885) as second or third-line treatment in combination with chemotherapy in non-small
cell lung cancer
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Phase III CANOPY-2 trial did not meet primary endpoint of overall
survival in patients with advanced or metastatic non-small cell lung cancer whose cancer progressed while on or after previous
treatments1
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Canakinumab development program continues; two Phase III non-small
cell lung cancer clinical trials are ongoing in first-line and adjuvant settings2,3
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The CANOPY clinical trial program is designed to help answer
critical questions about the role of interleukin-1 beta (IL-1β) in pro-tumor inflammation in
lung cancer, with multiple clinical trials investigating canakinumab in different stages of
disease using distinct treatment combinations2-5
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Basel, March 9, 2021 —
Novartis announced today the Phase III CANOPY-2 study evaluating canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1β),
in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival (OS)1.
The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed
while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy4.
Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings2,3.
Novartis and CANOPY-2 investigators will analyze the study data and are expected to submit its findings for presentation at an
upcoming medical meeting.
“While results from the CANOPY-2
trial are not what we hoped for in patients with advanced or metastatic non-small cell lung cancer who have been treated with other
lines of therapy, these data give us valuable insights into IL-1β inhibition,” said John Tsai, MD, Head of Global Drug
Development and Chief Medical Officer at Novartis. “Ongoing Phase III studies in non-small cell lung cancer continue, evaluating
canakinumab in earlier treatment settings. We sincerely thank the patients and clinical investigators involved in the CANOPY-2
study for their partnership.”
CANOPY-1, a Phase III study evaluating
canakinumab in combination with immunotherapy and chemotherapy, is expected to report final results before the end of the year2.
CANOPY-A, another Phase III study, is investigating canakinumab as an adjuvant therapy and has enrolled more than 950 patients
to date and is expected to enroll a total of 1,500 patients3.
About canakinumab (ACZ885)
Canakinumab is a human monoclonal
antibody that binds with high affinity and selectivity to human interleukin-1beta (IL-1β)6,7
and neutralizes IL-1β activity by blocking its interaction with its receptors8.
By neutralizing IL-1β, preliminary evidence suggests that canakinumab inhibits pro-tumor inflammation (PTI) to 1) enhance
anti-tumor immune response; 2) reduce tumor cell proliferation, survival and invasiveness; and 3) impair angiogenesis8.
Pro-tumor inflammation enables tumor development by driving cancer-causing processes and by suppressing anti-tumor immune responses9,10.
Canakinumab is a first-in-class interleukin-1beta (IL-1β) inhibitor of PTI in non-small cell lung cancer10.
About the CANOPY program
Novartis launched the CANOPY study
program after observing significantly lower than expected rates of lung cancer mortality among patients in the Phase III cardiovascular
CANTOS trial. The CANTOS trial evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following
a heart attack (CRP≥2 mg/L)8,9. Patients in the CANTOS trial
were also at high risk for inflammatory cancers, like lung cancer, due to advanced age, smoking history and other clinical risk
factors8,9. Based on these findings, Novartis launched three,
large-scale, randomized, Phase III clinical trials and a Phase II clinical trial to investigate canakinumab as a potential treatment
option in non-small cell lung cancer (NSCLC).
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CANOPY-1
(NCT03631199) is a Phase III trial evaluating canakinumab as a first-line treatment
for locally advanced or metastatic NSCLC in combination with pembrolizumab and
platinum-based doublet chemotherapy2
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CANOPY-2
(NCT03626545) is a Phase III trial investigating the role of canakinumab in combination
with the chemotherapy agent docetaxel in second or third-line therapy versus docetaxel
alone in NSCLC. Part 1 of the CANOPY-2 trial – a safety run-in study to determine
the appropriate dosage, was previously presented at ASCO 2019. Part 2 of the trial, reported
today, evaluated overall survival (OS)4
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CANOPY-A
(NCT03447769) is a Phase III trial studying canakinumab in the adjuvant setting,
following surgical resection and cisplatin-based chemotherapy. The adjuvant study is
designed to determine if treatment with canakinumab can prevent cancer relapse3
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CANOPY-N
(NCT03968419) is a non-registrational Phase II neoadjuvant trial evaluating canakinumab
in combination with pembrolizumab among patients with resectable NSCLC prior to their
planned surgery5
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Novartis and Lung Cancer
Lung cancer is the most common
cancer worldwide, accounting for more than 2 million new cases diagnosed each year11.
There are two main types of lung cancer – small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)12.
NSCLC accounts for approximately 85% of lung cancer diagnoses, resulting in nearly 1.7 million new
cases each year11,13. Currently, the five-year
survival rate for lung cancer is less than 20%14, decreasing
further when the disease is diagnosed at later stages15. The
majority of people with NSCLC are diagnosed with advanced or Stage III or IV disease16,
and treatment options are limited for people with lung cancer who experience cancer growth or progression while on standard of
care treatments17-19. More people die of lung cancer every
year than any other cancer type11. Novartis is committed to
developing best-in-class treatments for lung cancer patients around the world. With a focus on both targeted, personalized medicine
and the role of newer, immuno-oncology therapies, the lung cancer drug development program at Novartis is among the most robust
in the industry. With research activities informed by long-term relationships with leading lung cancer thought leaders and patient
advocates, Novartis is focused on reimagining the treatment of lung cancer.
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,” “potentially,” “can,” “will,”
“expected,” “committed,” “evaluating,” “continue,” “ongoing,” “approximately,”
or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for
canakinumab, either alone or in combination with docetaxel or pembrolizumab, or regarding potential future revenues from canakinumab,
either alone or in combination with docetaxel or pembrolizumab. 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 canakinumab, either alone or in combination with docetaxel or pembrolizumab 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 canakinumab, either alone or in combination with docetaxel or pembrolizumab, separately or in combination, 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, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases
such as COVID-19; safety, quality, data integrity 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 800 million people globally
and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities
work at Novartis around the world. Find out more at https://www.novartis.com.
Novartis is on Twitter. Sign up to
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For questions about the site or required
registration, please contact media.relations@novartis.com
References
2.
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ClinicalTrials.gov. Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet
Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC
Subjects (CANOPY-1). Available at: https://clinicaltrials.gov/ct2/show/NCT03631199. Accessed on February 9, 2021.
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3.
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ClinicalTrials.gov. Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy
in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A (Canopy-A). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03447769.
Accessed on February 9, 2021.
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4.
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ClinicalTrials.gov. Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination
With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy (CANOPY-2). Available at: https://clinicaltrials.gov/ct2/show/NCT03626545.
Accessed on February 9, 2021.
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5.
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ClinicalTrials.gov. A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as
Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N). Available
at: https://clinicaltrials.gov/ct2/show/NCT03968419. Accessed on February 9, 2021.
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6.
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Dhimolea E, mAbs 2010;2:3–13; 3. Ilaris [Prescribing Information T2016-102].
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7.
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Rondeau JM, Ramage P, Zurini M, Gram H. The molecular mode of action and species specificity of
canakinumab, a human monoclonal antibody neutralizing IL-1β. MAbs. 2015;7(6):1151-1160.
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8.
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Novartis data on file: Clinical Trial Protocol CACZ885M2301.
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9.
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Ridker PM, Thuren T, Zalewski A, et al. Interleukin-1β inhibition and
the prevention of recurrent cardiovascular events: rationale and design of the Canakinumab Anti-inflammatory Thrombosis Outcomes
Study (CANTOS). Am Heart J. 2011;162:597–605.
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10.
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Lu H, Ouyang W, Huang C. Inflammation, a key event in cancer development.
Mol Cancer Res. 2006;4(4):221-233.
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11.
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World Health Organization. Cancer. Available at: https://www.who.int/news-room/fact- sheets/detail/cancer.
Accessed on February 9, 2021.
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12.
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Lemjabbar-Alaoui H, Hassan O, Yang UW, et al. Lung cancer: biology and treatment options.
Biochim Biophys Acta. 2015. 1856(2):189-210.
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13.
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American Cancer Society. About Lung Cancer. Available at https://www.cancer.org/cancer/non-
small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html. Accessed February 9, 2021.
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14.
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Siegel R, Miller K, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70(1):7-30.
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15.
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Rami-Porta R, Asamura H, Traves W, et al. Lung cancer – major changes in the American Joint
Committee on Cancer eight edition cancer staging manual. CA Cancer J Clin. 2017;67:138.
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16.
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Mascaux C, Tomasini P, Greillier L, et al. Personalised medicine for non-small cell lung cancer.
Eur Respir Rev. 2017;26:170066.
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17.
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National Comprehensive Cancer Network Guidelines. Non-small cell lung cancer. Version 3. 2020.
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18.
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Sandler A, Gray R, Perry M, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small
cell lung cancer. New Engl J Med. 2006; 355: 2452-2550.
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19.
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Gadgeel S, Rodriguez-Abreu D, Speranza G, et al. Updated analysis from KEYNOTE-189: pembrolizumab
or placebo plus pemetrexed and platinum for previously untreated metastatic nonsquamous non-small cell lung cancer. J Clin Oncol.
2020; 38:1505-1517.
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# # #
Novartis Media Relations
E-mail: media.relations@novartis.com
Anja von Treskow
Director, Strategy & Financial Communications
+41 79 392 8697 (mobile)
anja.von_treskow@novartis.com
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Mary Curtin Creaser
Director, Global Oncology Communications,
Solid Tumors
+1 862 345-4102 (mobile)
mary.curtin_creaser@novartis.com
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Julie Masow
Novartis US External Communications
+1 862 579 8456
julie.masow@novartis.com
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Novartis Investor Relations
Central investor relations line: +41
61 324 7944
E-mail: investor.relations@novartis.com
Central
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North America
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Samir Shah
Thomas Hungerbuehler
Isabella Zinck
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+41 61 324 7944
+41 61 324 8425
+41 61 324 7188
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Sloan Simpson
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+1 862 778 5052
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SIGNATURES
Pursuant to
the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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Novartis AG
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Date: March 9, 2021
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By:
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/s/ PAUL
PENEPENT
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Name:
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Paul Penepent
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Title:
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Head Group Financial Reporting and
Accounting
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