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The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain. IBRANCE® (palbociclib) Prescribing Information for Great Britain click here. IBRANCE® (palbociclib) Prescribing Information for Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.

Real World Evidence

Confidence Through Experience1-9

There is a growing body of RWE for IBRANCE® in the UK and globally to complement PALOMA-2 and PALOMA-3 RCT data and to help support prescribing decisions for appropriate patients with HR+/HER2- ABC. 2–12

IBRANCE® has >6 years of cumulative real-world experience, and there is a growing body of RWE in the UK and globally to support the use of IBRANCE2-5,10,11

​​​​​​​Key IBRANCE® RWE studies are the ROISIRIS (UK) Study and the P-REALITY3-5,12​​​​​​​​​​
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Real-world IBRANCE® patient populations and subgroups (including patients with visceral disease) achieved outcomes that complement those demonstrated across the ​​​​​​​PALOMA RCTs2-12
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​​​​​​​In ROIS, 90% of the overall population achieved complete response, partial response or stable disease (2%, 40% and 48%, respectively).5 Time to best response in the overall population was 3.5 months.5 Patients treated first-line or with de novo disease have achieved better outcomes vs overall population5
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IBRANCE® demonstrates survival benefits in the real-world setting:

  • In the IRIS (UK) Study, 9 out of 10 patients were alive at 2 years (weighted with median patient numbers*)​​​​​​​​​​​​​​​​​​​​​

In P-REALITY, patients treated with IBRANCE® plus letrozole demonstrated significant improvement in rwPFS and OS compared with patients who received letrozole alone; median OS was not reached for patients receiving IBRANCE plus letrozole and was 43.1 months with letrozole alone†4

The safety profile of IBRANCE® is consistent between RCTs and RWE, with adverse events that can be effectively managed in real-world clinical practice2–9,13



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* Time frame >24 months where follow-up available. Survival rate defined as the time from the date of initiation of IBRANCE® combination therapy to the date of death due to any cause or end of follow-up (if earlier). Of the 255 patients in the IRIS UK cohort, 221 patients received IBRANCE® plus AI, survival rate 92.2%; 34 patients received IBRANCE® plus fulvestrant, survival rate 85.2%; the calculated weighted average is 91.3%
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† These data include patients with HR+/HER2− ABC who either received treatment with IBRANCE® plus AI or AI alone in the first-line setting. The median follow-up after sIPTW adjustment was 24.2 months (IQR, 14.2–34.9) in the IBRANCE® group and 23.3 months (IQR, 12.7–34.3) in those taking letrozole alone
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​​​​​​​The Value of RWE

RWE are generated or obtained from real-world practice rather than a clinical trial setting.14,15

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Therefore, the characteristics of real-world studies differ from those of RCTs.14,15

Observational retrospective analyses are not intended for direct comparison with clinical trials due to differences in study design and settings.


​​​​​​​Why is RWE important?


This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

ABC : Advanced Breast Cancer, AI : Aromatase Inhibitor, ET : Endocrine Therapy, HR+/HER2− : Hormone Receptor-Positive / Human Epidermal Growth Factor Receptor 2-Negative, IRIS : IBRANCE® Real-World Insights, IQR : Interquartile Range, LHRH : Luteinising Hormone-Releasing Hormone, OS : Overall Survival, P-REALITY : Palbociclib REAl-world first-LIne comparaTive effectiveness studYRCT : Randomised Controlled Trial, ROIS : Real Outcomes Ibrance Study, RWE : Real-World Evidence, rwPFS : Real-World Progression-Free Survival, sIPTW : Stabilised Inverse Probability of Treatment Weighting, SmPC : Summary of Product Characteristics

References
  1. IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
  2. Taylor-Stokes G, et al. Breast 2019;43:22–27.
  3. Pfizer Ltd. Data on file. IBRANCE® Real-World Insights (IRIS) – A Global Real-World Study on Palbociclib Outcomes – Results from the UK, 2020.
  4. DeMichele A, et al. Breast Cancer Res 2021;23:37–47.
  5. Palmieri C, et al. Poster #1710. Presented at the ESMO Congress 2021.
  6. Finn RS, et al. N Engl J Med 2016;375:1925–1936.
  7. Rugo HS, et al. Breast Cancer Res Treat 2019;174:719–729.
  8. Cristofanilli M, et al. Lancet Oncol 2016;17:425–439.
  9. Turner NC, et al. N Engl J Med 2018;379:1926–1936.
  10. Waller J, et al. J Glob Oncol 2019;5:JGO1800239.
  11. Mycock K, et al. Poster P510. Presented at the EBCC Virtual Congress, 2–3 October 2020.
  12. Taylor-Stokes G, et al. Poster 269P. Presented at ESMO Virtual Congress, 19–21 September 2020.
  13. Ettl J, et al. Breast Cancer Res 2020;22:27.
  14. Khozin S, et al. J Natl Cancer Inst 2017;109: doi: 10.1093/jnci/djx187.
  15. Singal AG, et al. Clin Transl Gastroenterol 2014:5.e45.
  16. Beaulieu-Jones, et al. Clin Pharmacol Ther 2020;107:843–852.
  17. Webster J and Douglas Smith B, Clin Ther 2019;41:336–349.
  18. Maissenhaelter BE, et al. Onkologie (Berl) 2018;23:91–98.
  19. Nordon C, et al. Value Health 2016;9:75–81.
  20. Mann CJ. Emerg Med J 2003;20:54–60.
  21. Portela MC, et al. Postgrad Med J 2015;91:343–354.
  22. Berger M, et al. Value Health 2017;20:1003–1008.
PP-IBR-GBR-4052. October 2021

Real World Evidence

Real-world patient data for IBRANCE® in advanced breast cancer
  • ROIS
  • IRIS (UK) Study
  • P-REALITY

Clinical Trials

  • Clinical Trial results for IBRANCE®
  • IBRANCE® Clinical Trials
  • PALOMA-2 Trial

Indication

  • IBRANCE® is indicated for the treatment of HR+/HER2- locally advanced or metastatic breast cancer:
       - In combination with an aromatase inhibitor; or
    ​​​​​​​   - In combination with fulvestrant in women who have received prior ET

    In pre- or perimenopausal women, the ET should be combined with a LHRH agonist

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