Press Release: Novartis data highlight efficacy -2-

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References

1. Ciruelos EM et al. Alpelisib + fulvestrant in patients with hormone

receptor-positive (HR+), human epidermal growth factor receptor

2-negative (HER2-), PIK3CA-mutated advanced breast cancer (ABC)

previously treated with cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) +

aromatase inhibitor (AI): 18-month follow-up of BYLieve Cohort A.

Presented at the San Antonio Breast Cancer Symposium, December 8, 2021.

Abstract #P1-18-03.

2. Rugo HS et al. Alpelisib + fulvestrant in patients with PIK3CA-mutated,

HR+, HER2- advanced breast cancer (ABC) who received chemotherapy or

endocrine therapy (ET) as immediate prior treatment: BYLieve Cohort C

primary results and exploratory biomarker analyses. Presented at the San

Antonio Breast Cancer Symposium, December 10, 2021. Abstract #PD13-05.

3. Chia S et al. Effect of duration of prior cyclin-dependent kinase 4/6

inhibitor (CDK4/6i) therapy (<=6 mo or >6 mo) on alpelisib benefit in

patients with hormone receptor-positive (HR+), human epidermal growth

factor receptor 2-negative (HER2-), PIK3CA-mutated advanced breast cancer

(ABC) from BYLieve. Presented at the San Antonio Breast Cancer Symposium,

December 8, 2021. Abstract # P1-18-08.

4. Juric D et al. Alpelisib + endocrine therapy (ET) in patients with

hormone receptor-positive (HR+), human epidermal growth factor receptor

2-negative (HER2-), PIK3CA-mutated advanced breast cancer (ABC)

previously treated with cyclin-dependent kinase 4/6 inhibitor (CDK4/6i):

Biomarker analyses from the Phase II BYLieve study. Presented at the San

Antonio Breast Cancer Symposium, December 8, 2021. Abstract #P5-13-03.

5. Turner N et al. Impact of ESR1 mutations on endocrine therapy (ET) plus

alpelisib benefit in patients with hormone receptor-positive (HR+), human

epidermal growth factor receptor 2-negative (HER2-), PIK3CA-mutated,

advanced breast cancer (ABC) who progressed on or after prior

cyclin-dependent kinase inhibitor (CDK4/6i) therapy in the BYLieve trial.

Presented at the San Antonio Breast Cancer Symposium, December 10, 2021.

Abstract #PD15-01.

6. Burstein HJ, Somerfield MR, Barton DL, et al: Endocrine treatment and

targeted therapy for HR-positive, HER2-negative metastatic breast Cancer:

ASCO Guideline update. J Clin Oncol. July 29, 2021.

7. Piqray (alpelisib) Prescribing Information. East Hanover, New Jersey,

USA: Novartis Pharmaceuticals Corporation; July 2021.

8. The Cancer Genome Atlas Network. Comprehensive molecular portraits of

human breast tumours. Nature. 2012;490(7418):61-70.

9. Mosele F, Stefanovska B, Lusque A, et al. Outcome and molecular landscape

of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol.

2020;31(3):377-386.

10. Fribbens, C., et al. Tracking Evolution of Aromatase Inhibitor Resistance

with Circulating Tumour DNA Analysis in Metastatic Breast Cancer. Ann

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11. Dustin D, et al. ESR1 Mutations in Breast Cancer. Cancer.

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

13. Novartis Pharmaceuticals. Study to Assess the Efficacy and Safety of

Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+),

HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6

Inhibitor and an Aromatase Inhibitor: EPIK-B5 (October 27, 2021- November

27, 2026). Identifier: NCT05038735.

https://www.clinicaltrials.gov/ct2/show/NCT05038735.

14. Novartis Pharmaceuticals. Study Assessing the Efficacy and Safety of

Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry

Either a PIK3CA Mutation or Have PTEN Loss: EPIK-B3 (June 8, 2020-January

9, 2026). Identifier: NCT04251533.

https://www.clinicaltrials.gov/ct2/show/NCT04251533.

15. Novartis Pharmaceuticals. EPIK-B2: A Two Part, Phase III, Multicenter,

Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the

Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab

and Pertuzumab as Maintenance Therapy in Patients With HER2-positive

Advanced Breast Cancer With a PIK3CA Mutation. Identifier: NCT04208178.

https://www.clinicaltrials.gov/ct2/show/ NCT04208178.

16. Novartis Pharmaceuticals. Alpelisib Plus Olaparib in

Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no

Germline BRCA Mutation Detected: EPIK-O (July 2, 2021-January 31, 2025).

Identifier: NCT04729387.

https://www.clinicaltrials.gov/ct2/show/NCT04729387.

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(END) Dow Jones Newswires

December 10, 2021 08:00 ET (13:00 GMT)