Press Release: Novartis Kisqali(R) Phase III -2-


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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.

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About Novartis

Novartis is reimagining medicine to improve and extend people's lives. We deliver high-value medicines that alleviate society's greatest disease burdens through technology leadership in R&D and novel access approaches. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. About 106,000 people of more than 140 nationalities work together to bring Novartis products to nearly 800 million people around the world. Find out more at https://www.novartis.com

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References

1. Novartis Data on File. Novartis Pharmaceuticals: 2022.

2. Pan, H, Gray, R, Braybrooke, J, et al. 20-year risks of breast-cancer

recurrence after stopping endocrine therapy at 5 years. N Engl J Med. Nov

2017;377(19):1836-1846. 10.1056/NEJMoa1701830

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

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

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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.

4. 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. Patis, France.

5. 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

6. Hortobagyi, 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.

7. 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

8. 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

9. 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.

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

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

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

(FUL) +/- ribociclib (RIB. Presented at the American Society of Clinical

Oncology Annual Meeting, June 5, 2021. Chicago, USA.

11. Tripathy D, Im S-A, Colleoni M, et al. Updated overall survival (OS)

results from the phase III MONALEESA-7 trial of pre- or perimenopausal

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

endocrine therapy (ET) +/- ribociclib. Presented at the San Antonio

Breast Cancer Symposium, December 9, 2020. Texas, USA.

12. Yardley, D, Nusch A, Yap YS, et al. Overall survival (OS) in patients

(pts) with advanced breast cancer (ABC) with visceral metastases (mets),

including those with liver mets, treated with ribociclib (RIB) plus

endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented

at the American Society of Clinical Oncology (ASCO) Annual Meeting. June

2020. Chicago, USA.

13. O'Shaughnessy J, Stemmer SM, Burris HA, et al. Overall survival subgroup

analysis by metastatic site from the Phase III MONALEESA-2 study of

first-line ribociclib + letrozole in postmenopausal patients with

HR+/HER2- advanced breast cancer. Presented at the San Antonio Breast

Cancer Symposium, December 7-10, 2021. Texas, USA.

14. Kisqali (ribociclib) Prescribing Information.

15. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines(R)) -

Breast Cancer. NCCN Guidelines.

https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.

Published March 2023. Accessed March 7, 2023.

16. 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

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

April 12, 2022. Accessed on September 15,

2022.https://www.cancer.org/cancer/breast-cancer/treatment/treatment-of-b

reast-cancer-by-stage/treatment-of-breast-cancer-stages-i-iii.html

18. European Society for Medical Oncology -- Magnitude of Clinical Benefit

Scale Scorecard.

https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-158-1.

Published April 20, 2020. Updated August 21, 2020. Accessed September 9,

2020.

19. European Society for Medical Oncology -- Magnitude of Clinical Benefit

Scale Scorecard.

https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-9-1.

Published March 29, 2022. Accessed April 1, 2022.

20. Ribociclib vs. palbociclib in patients with advanced breast cancer within

the HER2-enriched intrinsic subtype (HARMONIA). Identifier NCT05207709.

Revised April 4, 2022. Accessed on February 6, 2022.

https://clinicaltrials.gov/ct2/show/NCT05207709

21. Novartis and Vestre Viken Hospital Trust (2022, April 1 -- 2024, December

1). Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With

Ribociclib and Letrozole (NEOLETRIB). Identifier NCT05163106.

https://clinicaltrials.gov/ct2/show/NCT05163106

*Ibrance(R) is a registered trademark of Pfizer, Inc.

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(END) Dow Jones Newswires

March 27, 2023 01:15 ET (05:15 GMT)

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