RWE | IBRANCE® (palbociclib)

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

Ibrance® (palbociclib) Real-World Evidence

Confidence Through Experience^{1-31, 38-39}

RWE and data from RCTs each have their own complementary strengths and weaknesses that, when combined, can help regulators, clinicians and patients to better understand and utilise therapies.^32-37Please click on the video below to hear Dr Mark Verrill discuss the value of RWE to your clinical practice.

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

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.^{1–31, 38-39}

IBRANCE® has >7 years of cumulative real-world experience involving over 9000 patients worldwide.^{10-30, 38-39}

† This figure represents the number of patients receiving IBRANCE plus AI in the P-REALITY X study

As of July 2023

Key IBRANCE® RWE studies are the ROIS, IRIS and the P-REALITY X studies.

ROIS

A real-world analysis investigating the use, effectiveness and safety of IBRANCE^® within the IBRANCE^® Patient Program (IPP) in the UK.^21,38,39 This study was the first opportunity for patients with ABC to gain routine access to a CDK4/6 inhibitor^21,38,39

IRIS

A worldwide observational study of patients who received IBRANCE^® combination treatment in real-world setting. The study reviewed IBRANCE^® in combination with fulvestrant versus IBRANCE^® in combination with an AI^9–13,15

P-REALITY X

P-REALITY X is the largest real-world comparative effectiveness study, with a comparator arm, for mBC to date.* The study examined the effectiveness of first-line IBRANCE^® plus AI versus AI alone²⁰

*As of July 2023

RCTs and RWE

RWE is generated or obtained from real-world practice rather than in a clinical trial setting.³⁴
Therefore, the characteristics of real-world studies differ from those of RCTs.^33,34

	RCT: can the drug work? ^33-37	RWE: does the drug work? ^33-35
Measures	Efficacy	Effectiveness
Designed to determine causality	Yes	No
Randomisation	Randomised	Not Randomised
Eligibility criteria	Strict Patients tend to be different from those encountered in patient care	Broad Diverse in terms of age, race, socioeconomic status, disease severity, etc
Environment	Highly monitored and controlled	Routine clinical practice
Intervention	Strictly enforced and standardised	At the discretion of the treating physician
Data derived from	Prespecified, protocol-defined, uniformly assessed endpoints	Assessments of clinical judgement, with variability in patient care and adherence

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

Why is RWE important?

Strengths and limitations of RCTs and RWD studies

Header	Randomised Clinical Trials (RCT)^32-37	Real-world Data (RWD) studies^32-37
Strengths	Robust study design Randomisation minimises bias Blinding hides assignment from investigators, participants and assessors Well understood and accepted by stakeholders	Broader and more representitive population assessed over a longer time frame Assess a broad set of clinically relevant measures and outcomes Investigate questions that cannot ethically be studied in RCTs Inexpensive relative to clinical trials and faster to execute
Limitations	Significant differences between sample population and RW population - limits generalisability of results Study endpoints often focus on efficacy and safety Difficult to assess rare and long-term events Expensive to conduct and slow to execute	Absence of randomisation and blinding Higher risk of bias and presence of confounding factors Varying levels of data availability and quality Fewer standards around study designs

ABC: Advanced Breast Cancer, AI: Aromatase Inhibitor, CDK4/6: Cyclin-Dependent Kinase 4/6,
EHR: Electronic Health Records, ET: Endocrine Therapy, HR+ / HER2−: Hormone Receptor-Positive / Human Epidermal Growth Factor Receptor 2-Negative, IPP : IBRANCE® Patient Program,
IRIS: IBRANCE® Real-World Insights, LHRH: Luteinising Hormone-Releasing Hormone,
mBC: metastatic Breast Cancer, P-REALITY X: Palbociclib REAl-world first-LIne comparaTive effectiveness study eXtended, RCT: Randomised Controlled Trial, RWE: Real-World Evidence,
ROIS: Real Outcomes IBRANCE® Study

References

IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.

Finn RS, et al. N Engl J Med 2016;375:1925–1936.

Rugo HS, et al. Breast Cancer Res Treat 2019;174:719–729.

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Turner NC, et al. N Engl J Med 2018;379:1926–1936.

Mycock K, et al. Poster P510. Presented at the European Breast Cancer Conference, 2–3 October 2020, virtual.

Ettl J, et al. Breast Cancer Res 2020;22:27.

Taylor-Stokes G, et al. Poster 269P. Presented at the European Society for Medical Oncology Congress, 19–21 September 2020, virtual.

Pfizer Ltd. Data on file. IBRANCE Real-World Insights (IRIS) UK results, 2020. REF-PLB0472;

Taylor-Stokes G, et al. Breast 2019;43:22–27.

Waller J, et al. J Glob Oncol 2019;5:JGO1800239

Mycock K, et al. Curr Oncol 2021;28:678–688.

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Mycock K, et al. Clin Ther 2022;44:1588-1601.

Richardson D, et al. Breast Cancer Res Treat 2021;187:113–124.

De Laurentiis M, et al. Poster P3-11-25. Presented at San Antonio Breast Cancer Symposium, 14–10 December 2019, San Antonio, TX, USA.

Caillet P, et al. Presentation 1012. Presented at ASCO, 4–8 June 2021, Virtual.

NCT03280303. Available at: https://clinicaltrials.gov/ct2/show/NCT03280303 (accessed July 2023).

Rugo HS, et al. NPJ Breast Cancer 2022;8:114.

Palmieri C, et al. Poster 1710. Presented at the European Society for Medical Oncology Congress, 16–21 September 2021, virtual.

Goyal RK, et al. Cancer 2023;129:1051–1063.

Darden C, et al. Future Oncol 2019;15:141–150.

El Badri S, et al. Breast 2021;60:199–205.

Trocio J, et al. Poster P6-18-29. Presented at San Antonio Breast Cancer Symposium, 4–8 December 2018, San Antonio, TX, USA.

Karuturi MS, et al. Poster PS7-19. Presented at the San Antonio Breast Cancer Symposium, 8–12 December 2020, virtual.

Harbeck N, et al. Abstract 165P. Presented at ESMO, 2–4 May 2019, Berlin, Germany.

Karuturi MS, et al. Poster P1-18-25. Presented at San Antonio Breast Cancer Symposium, 7–10 December 2021, San Antonio, TX, USA.

Guarin A, et al. Poster 004. Presented at MBCC Conference, 7–8 August 2020, virtual symposium.

Palumbo R, et al. Ther Adv Med Oncol 2021;13:1–18.

Pfizer news. Positive real-world evidence for first-line IBRANCE combination therapy 2022. Available at: https://www.pfizer.com/news/announcements/pfizer-presents-positive-real-world-evidence-first-line-ibrancer-palbociclib (accessed July 2023).

de Lusignan S, et al. J Innov Health Inform 2015;22:368–373.

Khozin S, et al. J Natl Cancer Inst 2017;109:djx187.

Singal AG, et al. Clin Transl Gastroenterol 2014;5:e45.

Beaulieu-Jones BK, et al. Clin Pharmacol Ther 2020;107:843–852.

Webster J, Smith BD. Clin Ther 2019;41:336–349.

Maissenhaelter BE, et al. Onkologe (Berl) 2018;24(Suppl 2):91–98.

ClinicalTrials.gov. NCT03921866. Available at: https://clinicaltrials.gov/ct2/show/NCT03921866 (accessed July 2022).

Pfizer Ltd. Data on file. UK IBRANCE Patient Program Study (ROIS) results, 2021. REF-PLB0475.

PP-IBR-GBR-5165. July 2023

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