Press Release: Novartis Kisqali(R) NATALEE -2-

Kisqali has been approved in 99 countries worldwide, including by the United States Food and Drug Administration (FDA) and the European Commission. In the U.S., Kisqali is approved for the treatment of adult patients with HR+/HER2- advanced or MBC in combination with an AI as initial ET or fulvestrant as initial ET or following disease progression on ET in post-menopausal women or in men. In the EU, Kisqali is approved for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist(2) (0).

Novartis is committed to continuing to study Kisqali in breast cancer. Novartis is collaborating with SOLTI, which is leading the HARMONIA study to test whether Kisqali changes tumor biology to enable a better response to ET compared to Ibrance(R) ** (palbociclib) for patients with HR+/HER2-, HER2-enriched subtype(2) (4) MBC, and with the Akershus University Hospital in Norway on the NEOLETRIB trial, a neoadjuvant Phase II trial studying the effects of Kisqali in HR+/HER2- EBC to discover the potentially unique underlying mechanism of action(2) (5).

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

Please see full Prescribing Information for Kisqali, available at www.Kisqali.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," "may," "could," "would," "expect," "anticipate," "seek," "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, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; 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 a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

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References

1. Bardia A et al. Abstract: Invasive disease--free survival (iDFS) across

key subgroups from the Phase III NATALEE study of ribociclib (RIB) + a

nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2-

early breast cancer (EBC). Results to be presented at European Society

for Medical Oncology (ESMO) Congress on 23 October 2023. Madrid, Spain.

2. Slamon D, Stroyakovskiy D, Yardley D, et al. Ribociclib and endocrine

therapy as adjuvant treatment in patients with HR+/HER2- early breast

cancer: primary results from the Phase III NATALEE trial. Presented at

the American Society of Clinical Oncology Annual Meeting, June 2, 2023.

Chicago, USA.

3. Fasching P, Slamon D et al. Health-related quality of life in the phase 3

NATALEE study of adjuvant ribociclib plus a NSAI vs NSAI alone in

patients with HR+/HER2- early breast cancer). Presentation at European

Society for Medical Oncology (ESMO) Virtual Plenary on 14 September 2023.

4. Iqbal J, Ginsburg O, Rochon PA, Sun P, Narod SA. Differences in breast

cancer stage at diagnosis and cancer-specific survival by race and

ethnicity in the United States [published correction appears in JAMA.

2015 Jun 9;313(22):2287]. JAMA. 2015;313(2):165-173.

doi:10.1001/jama.2014.17322

5. Pan H, Gray R, Braybrooke J, et al; EBCTCG. 20-year risks of

breast-cancer recurrence after stopping endocrine therapy at 5 years. N

Engl J Med. 2017;377(19):1836-1846. doi:10.1056/NEJMoa1701830

6. Pan H, Gray R, Braybrooke J, et al; EBCTCG. 20-year risks of

breast-cancer recurrence after stopping endocrine therapy at 5 years. N

Engl J Med. 2017;377(19):1836-1846;(suppl). doi:10.1056/NEJMoa1701830

7. Gomis R, Gawrzak S. Tumor cell dormancy. Mol Oncol. 2017;11(1):62-78.

8. American Cancer Society. Treatment of breast cancer stages I-III. Revised

April 12, 2022. Available at:

https://www.cancer.org/cancer/breast-cancer/treatment/treatment-of-breast-cancer-by-stage/treatment-of-breast-cancer-stages-i-iii.html/

Accessed October 2023.

9. Yardley DA, Yap YS, et al. Pooled exploratory analysis of survival in

patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral

metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET)

in the MONALEESA (ML) trials. Poster presented at the European Society of

Medical Oncology Congress. September 9-13, 2022. Paris, France.

10. Neven P, Fasching PA, et al. Updated overall survival (OS) results from

the first-line (1L) population in the Phase III MONALEESA-3 trial of

postmenopausal patients with HR+/HER2- advanced breast cancer (ABC)

treated with ribociclib (RIB) + fulvestrant (FUL). Mini oral presented at

the European Society for Medical Oncology Breast Cancer Congress. May 4,

2022. Paris, France.

11. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with

Ribociclib plus Letrozole in Advanced Breast Cancer. New England Journal

of Medicine. 2022;386(10):942-950. doi:10.1056/NEJMoa2114663

12. Hortobagyi GN, et al. Overall survival (OS) results from the phase III

MONALEESA (ML)-2 trial of postmenopausal patients with hormone receptor

positive/human epidermal growth factor receptor 2 negative (HR+/HER2-)

advanced breast cancer (ABC) treated with endocrine therapy (ET) +/-

ribociclib. Proffered paper presented at the European Society of Medical

Oncology Congress, September 16-21, 2021. Lugano, Switzerland.

13. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus

endocrine therapy in breast cancer. New England Journal of Medicine.

2019;381(4):307-316. doi:10.1056/nejmoa1903765

14. Slamon DJ, Neven P, Chia S, et al. Overall Survival with Ribociclib plus

Fulvestrant in Advanced Breast Cancer. New England Journal of Medicine.

2020;382(6):514-524. doi:10.1056/NEJMoa1911149

15. Slamon DJ, Neven P, Chia S, et al. Overall survival (OS) results of the

Phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone

receptor--positive (HR+), human epidermal growth factor 2--negative

(HER2-) advanced breast cancer (ABC) treated with fulvestrant (FUL) +/-

ribociclib (RIB). Presented at the European Society of Medical Oncology

Congress, September 29, 2019, Barcelona, Spain.

16. Slamon D, Neven P, Chia S, et al. Updated overall survival (OS) results

from the Phase III MONALEESA-3 trial of postmenopausal patients (pts)

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