02.06.2023 13:59:50
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Press Release: Novartis Kisqali(R) significantly -2-
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) (3) 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) (4).
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 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.
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 103,000 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. 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.
2. Data on File. Novartis.
3. 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
4. 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
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;(suppl). doi:10.1056/NEJMoa1701830
6. Gomis R, Gawrzak S. Tumor cell dormancy. Mol Oncol. 2017;11(1):62-78.
7. 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
8. 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.
9. 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.
10. 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
11. 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.
12. 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
13. 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
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. Kisqali (ribociclib) Prescribing Information.
20. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines(R)) -
Breast Cancer. NCCN Guidelines. Published March 2023. Accessed May 31,
2023. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
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