Prescribing information

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Read about the PIK3CA mutation and PIQRAY® mechanism of action.   

PIK3CA is one of the most commonly mutated genes in HR+/HER2− advanced breast cancer.1,2

People graphic.

PIK3CA mutations may lead to hyperactivation of PI3Kα, a key upstream component of the PI3K pathway.15,22−26

Hyperactivation of the PI3K signalling pathway by PIK3CA mutations can result in acquired endocrine resistance in breast cancer cells.26

Combined endocrine and PI3K-directed treatment may overcome acquired resistance to endocrine therapy in HR+ HER2– advanced breast cancer.26,27

Testing for the PIK3CA mutation

Early knowledge of a tumour’s PIK3CA mutation status should inform the patient’s treatment plan.    

  • PIQRAY® (alpelisib) is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2−, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.

PIK3CA testing can be an important component of aBC management

Only patients whose tumour harbours a PIK3CA mutation are eligible for biomarker-driven therapy with PIQRAY® + fulvestrant.28

Patients with HR+/HER2− advanced breast cancer should be selected for treatment with PIQRAY® in combination with fulvestrant, based on the presence of a PIK3CA mutation in tumour or plasma specimens, using a validated test. If a mutation is not detected in a plasma specimen, tumour tissue should be tested if available.28†

 

In SOLAR-1, PIK3CA mutation status was determined with PCR, and any alteration on exons 7, 9, or 20 qualified patients for enrolment in the PIK3CA mutation cohort.15 For >90% of patients, the tissue tested was archival.29

ER, oestrogen receptor; HER2, human epidermal growth factor receptor 2; HR+, hormone receptor-positive; PI3K, phosphoinositide 3-kinase; PIK3CA, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; PCR, polymerase chain reaction.

References     

  1. The Cancer Genome Atlas Network. Nature 2012;490(7418):61−70.     
  2. Zardavas D, et al. Breast Cancer Res 2014;16(1):201.     
  3. Kingston B, et al. GS3-07. Presented at SABCS 2019; 10–14 December 2019; San Antonio, Texas, USA.     
  4. Di Leo A, et al. Lancet Oncol 2018;19(1):87−100.     
  5. Moynahan ME, et al. Br J Cancer 2017;116(6):726−730.
  6. Neven P, et al. PD2-05. Presented at SABCS 2018; 4–8 December 2018; San Antonio, Texas, USA.     
  7. Bardia A, et al. CT141. Presented at AACR 2019 Annual Meeting; 29 March−3 April 2019; Atlanta, Georgia, USA.
  8. Hortobagyi GN, et al. Ann Oncol 2018;29:1541−1547.
  9. Cristofanilli M, et al. Lancet Oncol 2016;17:425−439.
  10. Tolaney S, et al. 4458 Presented at AACR 2019 Annual Meeting; 29 March April 2019; Atlanta, Georgia, USA.
  11. Sobhani N, et al. J Cell Biochem 2018;119(6):4287–4202.
  12. Li SY, et al. Breast Cancer Res Treat 2006;96:91–95.
  13. Lai YL, et al. Ann Surg Oncol 2008;15:1064–1069.
  14. Mosele F, et al. Abstract 4895. Presented at AACR 2019 Annual Meeting; 29 March April 2019; Atlanta, Georgia, USA.
  15. André F, et al. N Engl J Med 2019;380(20):1929–1940.
  16. Moynahan ME, et al. J Clin Oncol 2016;34(15):519.
  17. Krop I, et al. Lancet Oncol 2016;17(6):811–821.
  18. MONALEESA-7 Clinical Study Report. Novartis data on file.
  19. Signorovitch J, et al. 1069. Presented at ASCO 2020; 29 May 2020; virtual meeting.
  20. Tolaney S, et al. 766/3. Presented at AACR Virtual Annual Meeting 2020; 22 June; virtual meeting II.     
  21. Cristofanilli M, et al. Eur J Cancer 2018;104:21–31.
  22. PIQRAY® (alpelisib) Core Data Sheet: Version 1.0. Novartis Pharma AG; November 2018.
  23. Al-Sukhun S, et al. Curr Breast Cancer Rep 2016;8:73−79.
  24. Goncalves MD, et al. N Engl J Med 2018;379(21):2052−2062.
  25. Croessmann S, et al. Clin Cancer Res 2018;24(6):1426−1435.
  26. Miller TW, et al. J Clin Invest 2010;120(7):2406−2413.
  27. Mayer IA, et al. Clin Cancer Res 2017;23(1):26−34.
  28. PIQRAY® (alpelisib) Summary of Product Characteristics. Novartis Pharma; 2020.
  29. Juric D, et al. GS3-08. Presented at SABCS; 4−8 December 2018; San Antonio, Texas, USA.     
HCP20-C003 September 2020.
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