06.12.2022 19:29:47

Press Release: Novartis Kisqali(R) prolonged PFS -2-

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References

1. Lu YS, Mahidin EIBM, et al. Primary results from the randomized Phase II

RIGHT Choice trial of premenopausal patients with aggressive HR+/HER2-

advanced breast cancer treated with ribociclib + endocrine therapy vs

physician's choice combination chemotherapy. Presented at the 2022 San

Antonio Breast Cancer Symposium (SABCS). December 6-10, 2022. Abstract #

GS1-10.

2. 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. Presented at the European Society of

Medical Oncology (ESMO) Congress. September 9-13, 2022. Abstract #205P.

3. 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). Presented at the

European Society for Medical Oncology (ESMO) Breast Cancer Congress. May

4, 2022. Abstract #LBA4, May 4, 2022.

4. Hortobagyi, et al. Overall Survival With Ribociclib Plus Letrozole in

Advanced Breast Cancer. N Engl J Med 2022; 386:942-50.

5. 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. Presented at the European Society of Medical Oncology (ESMO)

Congress, September 16-21, 2021. Abstract #LBA17.

6. Im, SA. et al. Overall Survival with Ribociclib plus Endocrine Therapy in

Breast Cancer. N Engl J Med 2019; 381:307-316.

7. Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im S-A, et al.

Overall survival with ribociclib plus fulvestrant in advanced breast

cancer. N Engl J Med. 2020;382(6):514--24.

8. Slamon, DJ, 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

(ESMO) Congress, September 29, 2019, Barcelona, Spain. Abstract #LBA7.

9. 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 (ASCO) Annual Meeting, June 5, 2021. Abstract #1001.

10. 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. Abstract #PD2-04.

11. Yardley, Denise, A. 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. Abstract

#1054.

12. O'Shaughnessy J 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. Abstract #GS2-01.

13. Novartis Data on File. Novartis Pharmaceuticals Corp: 2021.

14. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines

in Oncology (NCCN Guidelines(R)) -- Breast Cancer. Version 1.2022.

15. 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.

16. 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.

17. Kisqali (ribociclib) Prescribing Information. East Hanover, New Jersey,

USA: Novartis Pharmaceuticals Corporation.

18. Novartis Pharmaceuticals and Translational Research in Oncology (2018,

December 7 -- 2026, May 29). A Trial to Evaluate Efficacy and Safety of

Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With

HR+/HER2- Early Breast Cancer (NATALEE). Identifier NCT03701334.

https://clinicaltrials.gov/ct2/show/NCT03701334.

19. Pascual T, Stover D, et al. HARMONIA SOLTI-2101/AFT-58: A head-to-head

phase III study comparing ribociclib (RIB) and Palbociclib (PAL) in

patients with hormone receptor-positive/HER2-negative/HER-Enriched

(HR+/HER2-/HER2-E) advanced breast cancer (ABC). Presented at the

European Society of Medical Oncology (ESMO) Congress. September 9-13,

2022. Abstract #272TiP.

20. 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

December 06, 2022 13:30 ET (18:30 GMT)

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