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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 Outcomes IBRANCE® Study (ROIS)

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
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Learn more about IBRANCE® Real World Evidence.​​​​​​
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ROIS Summary

Professor Carlo Palmieri
Consultant in Medical Oncology
The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool


​​​​​​​Hear Professor Carlo Palmieri, the Author of ROIS, summarise the data from the IBRANCE® ROIS Real World Study.

IBRANCE® ROIS POSTER

Presented at ESMO September 2021

Download the poster to read more about the IBRANCE® ROIS Study

The IBRANCE® Patient Program (IPP) was initiated to provide patients with HR+ HER2- mBC with routine access to the first-in-class CDK4/6 inhibitor treatment option, IBRANCE®. The IPP, provided 848 patients with access to IBRANCE® free-of-charge; 150 of these patients are still receiving IBRANCE® today5,13–14

ROIS is an observational cohort study of 191 Patients who were enrolled in IPP5,15

​​​​​​​​​IBRANCE® demonstrates survival benefit in RW patient populations and subgroups, with better outcomes observed when treatment is initiated early5,16

  • In the overall population (N=191), 9 out of 10 patients achieved CR, PR or SD. In the de novo (n=57) population this increased to 94%5,16
  • ​​​​​​​Time to best response§ was 3.5 months in the overall population5,16
  • In the overall population, patients being treated with IBRANCE® achieved a mPFS of 19.5 months. In those patients who received IBRANCE® as a first-line therapy, this increased to 22.5 months, with an mPFS not reached in patients with de novo (n=57) mBC5,16
  • Median OS was not reached for patients in any population or subgroup.5

The safety profile of IBRANCE® in the ROIS trial was consistent between that seen in RCTs and other RWE, with febrile neutropenia reported in 3% of patients (n=6).1,5,16

* Data from August 2021.
† CR, PR or SD: 2%, 40% and 48%, respectively.
Patients diagnosed with de novo mBC.
§ Best clinical response includes CR, PR, SD and PD.
Patients with no prior treatments prescribed in the metastatic setting prior to IBRANCE® initiation.​​​​


​​​​​​​ROIS Study Design

The overall study observation period for this analysis was from the date of breast cancer diagnosis until 24 months after initiation of IBRANCE®.5,15

Patient demographic and clinical characteristics in ROIS were consistent with the UK population of patients with breast cancer5,16–19

  • The median age of patients treated with IBRANCE® was 57.0 years old5
  • A total of 30% of the patients were diagnosed de novo mBC and 32% of the patients had visceral disease5
  • The most common site of metastatic spread was bone5
  • The majority of the patients were postmenopausal by the time they were diagnosed with metastatic disease5

* First line (n=40), first-line IBRANCE® added (n=10), second line (n=7).
† Not available in the notes (n = 11).
‡ Not available in the notes due to time of initial BC diagnosis (n=11), not available in the notes (n=9).
§ Menopausal status not available for 1 male patient (1%) and not available for 5 patients (3%).
¶ Defined as time from last known date on (neo)adjuvant therapy (hormone therapy, chemotherapy or radiotherapy).
** Treatment dates are not available due to time of initial BC diagnosis (n=3), patient previously treated at a different hospital and so treatment dates are not available (n = 2), patient had no (neo)adjuvant hormone therapy (n=4), no prior hormone therapy recorded (n=16).
†† Not available in the notes (n=2).
‡‡ Not available in the notes (n=2).
§§ Includes any patient, regardless of treatment line group, with at least one hormone therapy recorded as being in the advanced/disease-modifying/metastatic setting.

In the overall population, 9 out of 10 patients achieved either CR, PR or SD.5

Patients with de novo* disease treated with IBRANCE® had a shorter median time to best response than the overall and first-line patient populations.16

Patients diagnosed with de novo mBC.
† Best clinical response includes CR, PR, SD and PD.
‡ Patients with no prior treatments prescribed in the metastatic setting prior to IBRANCE® initiation.

In the real-world setting, a PFS benefit is observed in patients treated with IBRANCE®.5,16

Patients had a mPFS of 19.5 months in the overall patient population. When used as a first-line** treatment option, this PFS benefit of IBRANCE® extended to nearly 2 years (mPFS: 22.5 months).5,16

PFS Probability*5​​​​​​​

Figure adapted from Palmieri C et al. 2021.

​​​​​​​* Estimated via Kaplan–Meier analysis.
** Patients with no prior treatments prescribed in the metastatic setting prior to IBRANCE® initiation.
Patients diagnosed with de novo metastatic BC.
Patients receiving IBRANCE® after at least one other treatment in the metastatic setting.

At 2 years, mOS was not reached in any patient population or subgroup in the ROIS study this complements the data in PALOMA-2 and PALOMA-3 clinical trials.5,7-8

OS Probability*5

Figure adapted from Palmieri C et al. 2021.

* Estimated via Kaplan Meier analysis.
** Patients with no prior treatments prescribed in the metastatic setting prior to IBRANCE® initiation.
† Patients diagnosed with de novo metastatic BC.
‡ Patients receiving IBRANCE® after at least one other treatment in the metastatic setting.

The safety profile in ROIS was consistent with that seen in RCTs and previous RWE studies, with febrile neutropenia reported in 3% of patients (n=6).1,5,16

* Based on ANC values recorded in the 6 months post IBRANCE®  initiation, represents the worst Grade of neutropenia experienced for each patient.


​​​​​​​Treatment Patterns

The overall median (95% Cl) duration of IBRANCE® treatment was 19.3 (13.9–NR) months. When used as first-line* therapy or in patients diagnosed with de novo metastatic breast cancer, the median duration of treatment was not reached.5,16

* Patients with no prior treatments prescribed in the metastatic setting prior to IBRANCE® initiation.


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.

AI : Aromatase Inhibitor, ANC : Absolute Neutrophil Count, BC : Breast Cancer, CI : Confidence Interval, CR : Complete Response, ET : Endocrine Therapy, HR+/HER2− : Hormone Receptor-Positive / Human Epidermal Growth Factor Receptor 2-Negative, IPP : IBRANCE® Patient Program, LHRH : Luteinising Hormone-Releasing Hormone, mPFS : Median Progression-Free Survival, NICE : National Institute for Health and Care Excellence, NR : Not Reached, OS : Overall Survival, PFS : Progression-Free Survival, PR : Partial Response, RCT : Randomised Controlled Trial, ROIS : Real Outcomes IBRANCE® Study, RWE : Real World Evidence​​​​​​​, SD : Stable Disease, SMC : Scottish Medicines Consortium, 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. Pfizer. Records from IPP. 
  14. PharmaTimes online. Pfizer offers IBRANCE free to NHS during NICE appraisal. Available at: http://www.pharmatimes.com/news/pfizer_offers_ibrance_free_to_the_nhs_during_nice_appraisal_1192363 (accessed September 2021) 
  15. Clinical Trials.gov. NCT03921866. UK IBRANCE Patient Program (IPP) Study (ROIS). 
  16. Pfizer. Data on file. Real Outcomes IBRANCE Study (ROIS) – A UK IBRANCE Patient Program (IPP) Study – Results from 2021. 
  17. Cancer Research UK. Breast cancer incidence (invasive) statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer/incidence-invasive (accessed September 2021). 
  18. Kurosky S, et al. Poster #PCN352. Presented at International Society For Pharmacoeconomics and Outcomes Research 18th Annual European Congress 2015. 
  19. Rigg A, et al. Post Reprod Health 2019;25:21–32.
PP-IBR-GBR-4015. October 2021

Real-World Evidence

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

  • IBRANCE® Real World Evidence
  • 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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PP-PFE-GBR-3863. November 2021

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