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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.

P-REALITY X: Palbociclib Real-World First-Line Comparitive Effectiveness Study Extended

Confidence Through Experience1-10

There is a growing body of real world evidence 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.2-13

Learn more about IBRANCE® Real World Evidence.

Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.

P-REALITY X Summary

Professor Cristofanilli
Director of Breast Medical Oncology and Associate Director of Precision Oncology at the Weill Cornell Medicine Meyer Cancer Center in New York, USA.


P-REALITY X Study Summary 

  • First-line IBRANCE® in combination with an AI improves both real-world OS and real-world PFS versus AI alone, in patients with HR+/HER2− mBC. This is true across various patient subgroups (e.g. patients over 70 years old and those with bone-only and visceral disease).2
  • Significant improvement in real-world OS of 5.9 months was observed with IBRANCE® plus AI versus AI alone,* resulting in a 24% reduction in risk of mortality.​​​​​​​†2
  • Significant improvement in real-world PFS of 5.4 months observed with IBRANCE® plus AI versus AI alone, leading to a 30% reduction in the risk of disease progression.†2
  • P-REALITY X is the largest real-world comparative effectiveness study for IBRANCE® to date§ with over 5 years of patient data collected with a comparator control arm.2
*49.1 months for IBRANCE plus AI (n=1572) vs 43.2 months for AI alone (n=1137). Hazard ratio=0.76 [95% CI: 0.68–0.87], p=0.00012
sIPTW adjusted analysis
19.3 months for IBRANCE plus AI (n=1572) vs 13.9 months (n=1137) for AI alone Hazard ratio=0.70 [95% CI: 0.62–0.78], p<0.00012
§As of April 2022

 

P-REALITY X Poster

Presented at ESMO, May 2022

Download Poster

P-REALITY X Study Design

This study was a retrospective analysis of EHRs of 2888 patients with HR+/HER2− mBC enrolled in the Flatiron Health Analytic Database. The study aimed to describe patient characteristics and real-world effectiveness of IBRANCE® plus an AI versus an AI alone in the first-line setting.2

*Real-world OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date
Real-world PFS was defined as the time from index date to the date of the first documentation of progressive disease or death due to any cause, whichever occurs first. Patients last known to be alive and progression-free within the follow up cut-off date are censored at the date of the last clinic note.

Key Baseline Characteristics

Baseline characteristics were well balanced in this large and diverse population after sIPTW.*2

*Real-world OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date; †real-world PFS was defined as the time from index date to the date of the first documentation of progressive disease or death due to any cause, whichever occurs first. Patients last known to be alive and progression-free within the follow up cut-off date are censored at the date of the last clinic note.

*sIPTW was applied to patients to balance baseline demographic and clinical characteristics and to adjust for differences in observed potential confounders between the two cohorts2
PSM can be used to minimise bias in real-world studies by matching patients across treatment groups, to ensure patient characteristics are balanced14
Visceral disease was defined as metastatic disease in the lung and/or liver; patients could have other sites of metastases.2

Effectiveness: Real-World OS

IBRANCE® plus AI significantly prolonged median OS* by 5.9 months compared with AI alone (median 49.1 vs 43.2 months; HR=0.76; [95% CI: 0.65–0.87]; p=0.0001) in a heterogeneous population of patients with HR+/HER2− mBC, with consistent median OS improvements across the majority of patient subgroups.2 This resulted in a 24% reduction in the risk of death with IBRANCE® plus AI versus AI alone.2

Real-World OS:* sIPTW Adjusted Analysis

Figure adapted from Rugo H, et al. 2022.
​​​​​​​
*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by the Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off  date
†sIPTW was applied to patients to balance baseline demographic and clinical characteristics and to adjust for differences in observed potential confounders between the two cohorts.

Real-World OS:* Unadjusted Analysis

Figure adapted from Rugo H, et al. 2022.

*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by the Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date. 

Real-World OS:* PSM Adjusted Analysis

Figure adapted from Rugo H, et al. 2022.

*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by Flatiron in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date
PSM can be used to minimise bias in real-world studies by matching patients across treatment groups, to ensure patient characteristics are balanced.

P-REALITY X OS in the Patient Subgroups (sIPTW Adjusted Analysis)2

IBRANCE® plus AI improves real-world OS versus AI alone in the majority of subgroups.*†

Figure adapted from Rugo H, et al. 2022.

*sIPTW adjusted analysis. sIPTW was applied to patients to balance baseline demographic and clinical characteristics and to adjust for differences in observed potential confounders between the two cohorts
Small patient numbers can be a limitation of subgroup analyses. These analyses are considered exploratory. No adjustments were made for multiple testing.


Effectiveness: Real-World PFS

IBRANCE® plus AI significantly prolonged real-world PFS* by 5.4 months compared with AI alone (median 19.3 vs 13.9 months; HR=0.70; [95% CI: 0.62–0.78]; p<0.0001) in a heterogeneous population of patients with HR+/HER2− mBC.2 This resulted in a 30% reduction in the risk of disease progression with IBRANCE® plus AI versus AI alone.2

Real-World PFS:* sIPTW Adjusted Analysis

Figure adapted from Rugo H, et al. 2022.

*Real-world PFS was defined as the number of months from start of IBRANCE® plus AI or AI alone to death or disease progression (concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment). If patients did not die or have disease progression, they were censored at the date of initiation of next line of therapy for those with two or more lines of therapy or their last visit during the study period for patients with only one line of therapy
sIPTW was applied to patients to balance baseline demographic and clinical characteristics and to adjust for differences in observed potential confounders between the two cohorts.
​​​​​​​

Real-World PFS:* Unadjusted Analysis

Figure adapted from Rugo H, et al. 2022.

*Real-world PFS was defined as the number of months from start of IBRANCE® plus AI or AI alone to death or disease progression (concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment). If patients did not die or have disease progression, they were censored at the date of initiation of next line of therapy for those with two or more lines of therapy or their last visit during the study period for patients with only one line of therapy.

Real-World PFS:* PSM Adjusted Analysis

Figure adapted from Rugo H, et al. 2022.

*Real-world PFS was defined as the number of months from start of IBRANCE® plus AI or AI alone to death or disease progression (concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment). If patients did not die or have disease progression, they were censored at the date of initiation of next line of therapy for those with two or more lines of therapy or their last visit during the study period for patients with only one line of therapy
PSM can be used to minimise bias in real-world studies by matching patients across treatment groups, to ensure patient characteristics are balanced.

P-REALITY X supports the use of first-line IBRANCE® plus AI as a standard of care for patients with HR+/HER2- mBC.2

IBRANCE® Safety Profile1

Safety data was not collected as part of the P-REALITY X study. 

  • The overall safety profile of palbociclib is based on pooled data from 872 patients who received palbociclib in combination with ET (n=527 in combination with letrozole and n=345 in combination with fulvestrant) in randomised clinical studies in HR+/HER2- locally advanced or mBC1,15
  • The most frequent (≥20%) adverse reactions of any grade reported in patients receiving palbociclib in randomised clinical studies were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anaemia, diarrhoea, alopecia and thrombocytopenia1 
  • The most frequent (≥2%) Grade ≥3 adverse reactions of palbociclib were neutropenia, leukopenia, infections, anaemia, AST increased, fatigue and ALT increased1
  • Across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3), 1.4% of IBRANCE-treated patients had ILD/pneumonitis of any grade. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea). In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis1
  • Across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3), 1.4% of IBRANCE-treated patients experienced febrile neutropenia of any grade. In cases of febrile neutropenia, IBRANCE should be withheld until recovery of neutropenia to Grade ≤2  and then resumed at the next lower dose at the beginning of the following cycle1

For full safety information please consult the IBRANCE® Summary of Product Characteristics.


ABC: advanced breast cancer, AI: Aromatase Inhibitor, CI: Confidence Interval, Dx: diagnosis, ECOG PS: Eastern Cooperative Oncology Group performance status, EHR: Electronic Health Record, ESMO: European Society for Medical Oncology, ET: Endocrine Therapy, HER2− : Human Epidermal Growth Factor Receptor 2-negative, HR+: Hormone Receptor-positive, HR: Hazard Ratio, IPTW: inverse Probability of Treatment Weighting, IQR: interquartile range, LHRH: Luteinising Hormone-Releasing Hormone, mBC: metastatic Breast Cancer; (m)OS: (median) Overall Survival, (m)PFS: (median) Progression-Free Survival, PSM: Propensity Score Matching, RCT: Randomised Control Trial, rw: real-world, RWE: Real-World Evidence, sIPTW: stabilised inverse Probability of Treatment Weighting, TR: tumour response, y: year

References
  1. IBRANCE® (palbociclib) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/11962/smpc (Great Britain) and https://www.emcmedicines.com/en-gb/northernireland/medicine?id=226d5ffd-df7d-437e-bc7f-3b61a5145aad (Northern Ireland).
  2. Rugo H, et al. Poster 169P. Presented at ESMO Breast Cancer Congress, 3–5 May 2022, Berlin, Germany.
  3. Taylor-Stokes G, et al. Breast 2019;43:22–27.
  4. Pfizer Ltd. Data on file. IBRANCE® Real-World Insights (IRIS) – A Global Real-World Study on Palbociclib Outcomes – Results from the UK, 2020. 
  5. DeMichele A, et al. Breast Cancer Res 2021;23:37–47.
  6. Palmieri C, et al. Poster #1710. Presented at the ESMO Virtual Congress, 16–21 September 2021.
  7. Finn RS, et al. N Engl J Med 2016;375:1925–1936.
  8. Rugo HS, et al. Breast Cancer Res Treat 2019;174:719–729.
  9. Cristofanilli M, et al. Lancet Oncol 2016;17:425–439.
  10. Turner NC, et al. N Engl J Med 2018;379:1926–1936.
  11. Waller J, et al. J Glob Oncol 2019;5:JGO1800239. 
  12. Mycock K, et al. Poster P510. Presented at the EBCC Virtual Congress, 2–3 October 2020.
  13. Taylor-Stokes G, et al. Poster 269P. Presented at ESMO Virtual Congress, 19–21 September 2020.
  14. Austin PC. Multivariate Behav Res 2011;46:399–424.
  15.  Diéras V, et al. J Natl Cancer Inst 2019;111:419-430.
PP-IBR-GBR-4615. July 2022

Real World Evidence

  • Real-world patient data for IBRANCE® in advanced breast cancer
  • IBRANCE® Real World Evidence​​​​​​​​​​​​

  • ROIS
    ​​​​​​​
    IRIS (UK) Study
    ​​​​​​​

Clinical Trials

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

    ​​​​​​​PALOMA-3 Trial

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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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PP-PFE-GBR-3863. November 2021

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