Press Release: New Novartis data demonstrate only -2-

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References

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

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

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

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

3. 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).

4. Im, S. A. et al. Overall Survival with Ribociclib plus Endocrine Therapy

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

5. 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.

6. 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 (LBA7).

7. 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).

8. 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.

9. 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) meeting (Abstract #1054).

10. 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).

11. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines

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

12. 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.

13. 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.

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

USA: Novartis Pharmaceuticals Corporation; July 2020.

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

16. 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.

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

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(END) Dow Jones Newswires

May 04, 2022 03:00 ET (07:00 GMT)