06.12.2022 19:29:47
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Press Release: Novartis Kisqali(R) prolonged PFS -2-
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 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
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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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December 06, 2022 13:30 ET (18:30 GMT)
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