-- 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 
 
   -- Canakinumab development program continues; two Phase III non-small 
      cell lung cancer clinical trials are ongoing in first-line and adjuvant 
      settings2,3 
 
   -- The CANOPY clinical trial program is designed to help answer critical 
      questions about the role of interleukin-1 beta (IL-1) in pro-tumor 
      inflammation in lung cancer, with multiple clinical trials investigating 
      canakinumab in different stages of disease using distinct treatment 
      combinations2-5 
 
 
   Basel, March 9, 2021 -- Novartis announced today the Phase III CANOPY-2 
study evaluating canakinumab (ACZ885), an inhibitor of interleukin-1beta 
(IL-1), 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 
immunotherapy(4) . Two Phase III CANOPY trials continue, evaluating 
canakinumab in first-line and adjuvant settings(2,3) . 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-1 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 year(2) . 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 
patients(3) . 
 
   About canakinumab (ACZ885) 
 
   Canakinumab is a human monoclonal antibody that binds with high affinity 
and selectivity to human interleukin-1beta (IL-1)(6) (,) (7)  and 
neutralizes IL-1 activity by blocking its interaction with its 
receptors(8) . By neutralizing IL-1, 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 angiogenesis(8) . Pro-tumor inflammation 
enables tumor development by driving cancer-causing processes and by 
suppressing anti-tumor immune responses(9,10) . Canakinumab is a 
first-in-class interleukin-1beta (IL-1) inhibitor of PTI in 
non-small cell lung cancer(10) . 
 
   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 factors(8,9) . 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). 
 
 
   -- 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 
 
   -- 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 
 
   -- 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 
 
   -- 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 
 
 
 
   Novartis and Lung Cancer 
 
   Lung cancer is the most common cancer worldwide, accounting for more 
than 2 million new cases diagnosed each year(1) (1) . There are two main 
types of lung cancer -- small cell lung cancer (SCLC) and non-small cell 
lung cancer (NSCLC)(1) (2) . NSCLC accounts for approximately 85% of 
lung cancer diagnoses, resulting in nearly 1.7 million new cases each 
year(11) (,) (1) (3) . Currently, the five-year survival rate for lung 
cancer is less than 20%(1) (4) , decreasing further when the disease is 
diagnosed at later stages(1) (5) . The majority of people with NSCLC are 
diagnosed with advanced or Stage III or IV disease(1) (6) , and 
treatment options are limited for people with lung cancer who experience 
cancer growth or progression while on standard of care treatments(1) (7) 
(-) (19) . More people die of lung cancer every year than any other 
cancer type(11) . 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

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