22.08.2020 07:14:40

Press Release: Novartis provides update on Phase -2-

arthralgia, peripheral edema, and cough. The most common side effects

for patients with stage III melanoma receiving the combination as

adjuvant therapy are: pyrexia, fatigue, nausea, headache, rash, chills,

diarrhea, vomiting, arthralgia, and myalgia. The most common side

effects for patients with NSCLC: pyrexia, fatigue, nausea, vomiting,

diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage,

cough, and dyspnea.

Please see full Prescribing Information for Tafinlar at

https://www.novartis.us/sites/www.novartis.us/files/tafinlar.pdf

and Mekinist at :

https://www.novartis.us/sites/www.novartis.us/files/mekinist.pdf

https://www.novartis.us/sites/www.novartis.us/files/mekinist.pdf.

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," "will," "may," "could," "should,"

"believe," "committed," "investigational," "continues," "to support,"

"approximately," or similar terms, or by express or implied discussions

regarding potential marketing approvals, new indications or labeling for

spartalizumab and Tafinlar + Mekinist, separately or in combination, or

regarding potential future revenues from spartalizumab and Tafinlar +

Mekinist, separately or in combination. 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 spartalizumab and Tafinlar + Mekinist,

separately or in combination, 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 spartalizumab and

Tafinlar + Mekinist, separately or in combination, will be commercially

successful in the future. In particular, our expectations regarding

spartalizumab and Tafinlar + Mekinist, separately or in combination,

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 109,000 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 follow @Novartis at

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https://www.novartis.com/news/media-library

https://www.novartis.com/news/media-library

For questions about the site or required registration, please contact

media.relations@novartis.com

Novartis Media Relations

E-mail: media.relations@novartis.com

Anja von Treskow Mary Curtin Creaser

Novartis External Communications Novartis Oncology Communications

+41 79 392 8697 +1 862 345 4102

anja.von_treskow@novartis.com mary.curtin_creaser@novartis.com

Eric Althoff

Novartis US External Communications

+1 646 438 4335

eric.althoff@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 Sloan Simpson +1 862 778 5052

Thomas Hungerbuehler +41 61 324 8425

Isabella Zinck +41 61 324 7188

References

1. Hauschild A, et al. Long-term benefit of adjuvant dabrafenib + trametinib

(D+T) in patients (pts) with resected stage III BRAF V600--mutant

melanoma: 5-year analysis of COMBI-AD. Abstract #10001. 2020 American

Society of Clinical Oncology Annual Meeting, May 29-June 2, Chicago, IL.

2. Robert C, et al. Five-Year Outcomes with First-Line Dabrafenib plus

Trametinib in Metastatic Melanoma. The New England Journal of Medicine.

2019.

3. ClinicalTrials.gov. A Study of the Anti-PD1 Antibody PDR001, in

Combination With Dabrafenib and Trametinib in Advanced Melanoma

(COMBI-i). https://clinicaltrials.gov/ct2/show/NCT02967692.

(END) Dow Jones Newswires

August 22, 2020 01:15 ET (05:15 GMT)

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