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MOA MOA MOA EfficacyEfficacyPALOMA-2 Study designPatient Characteristics Primary endpoint Secondary end point PALOMA-3Study design Patient Characteristics Primary endpoint Secondary end point SurvivalFinal analysis Subgroup analysis Prespecified groups Updated Subgroup analysis Safety Safety PALOMA pooled analysis Adverse reactions  & Laboratory abnormalities PALOMA 2 Adverse Events PALOMA 3 Adverse Events IBRANCE consistent  safety profile Pooled analysis of patients aged ≥65 years in the PALOMA trials No evidence of cumulative or delayed toxicity with up to 50 months Patients with visceral diseases GI ,  Liver toxicities, and QTC Dosing Dosing Once daily dosing Dose Modification Real-World EvidenceReal-world EvidenceIBRANCE is the only CDK4/6 inhibitor with >5 years of real-world experience Real-world data provide additional information Favorable progression free rates IRIS Study In the real world, IBRANCE benefits GuidelinesGuidelinesNCCN Guidelines ESMO Guidelines Support & Services Support & Resources Patient support program/tools Events Materials Videos
Ibrance®  US Prescribing Information  Click Here
The first CDK4/6 inhibitor to demonstrate favourable effectiveness in response rates and progression-free rates in the real-world setting*1- The IRIS study was an observational retrospective chart review that evaluated the  demographics, clinical characteristics, treatment patterns and clinical outcomes in  patients with HR+/HER2- ABC/mBC treated with IBRANCE combinations in the real-world setting in the United States, Argentina and Germany.

 In 652 patients in the United States*1:
  • CBR was >90% for both patients treated with IBRANCE + AI and IBRANCE + FUL. For the majority of patients, PR or SD was reported as best response by the physician†
  • 79.8% of patients treated with IBRANCE + FUL in first-line or later treatment were progression free at 1 year
*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.2,3

†Clinical response was based on physician assessment reported at any time and was not based on the RECIST criteria. In RCTs, RECIST criterion for a PR is a ≥30% reduction in tumour size. In IRIS, CR was defined as one where ‘CR’ has been recorded at any time (no 24-week minimum); PR was defined as one where ‘PR’ has been recorded at any time (no 24-week minimum); CBR was calculated by adding the percentages of patients who achieved CR, PR and SD ≥24 weeks; SD ≥24 weeks was defined as patient remained on IBRANCE for a minimum of 24 weeks, without complete or PR, death, treatment switch, or progression; SD <24 weeks was defined as SD recorded for initial response, with a subsequent progression recorded <24 weeks or treatment switch for reason other than progression <24 weeks or death without recorded progression <24 weeks; progressive disease was recorded for patients with initial response without a subsequent partial or CR recorded.1
‡Fulvestrant combination approved in the United States in February 2016, therefore, 18- and 24-month data unavailable. ABC = advanced breast cancer; AI = aromatase inhibitor; CBR = clinical benefit response; CDK = cyclin-dependent kinase; FUL = fulvestrant; HER2- = human epidermal growth factor receptor 2-negative; HR+ = hormone receptor-positive; IRIS = the ibrance real world insights; mBC = metastatic breast cancer; PR = partial response; RCT = randomized control trial; RECIST= Response Evaluation Criteria in Solid Tumours; SD = stable disease.

References: 1. Taylor-Stokes G, et al. Breast. 2019;43:22-27. 2. Gerstein HC, et al. Lancet. 2019;393(10168):210-211. 3. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868. The IRIS study population included a diverse group of
HR+/HER2- ABC/mBC patients*1Patient demographics were similar between the IBRANCE + AI and IBRANCE + FUL cohorts1:
  • Median age at IBRANCE initiation was 65 years (range: 30-90)
  • 64.3% of patients had comorbidities†2
  • 60.0% were of white/Caucasian ethnicity
Adapted from Taylor-Stokes G, et al. 2019.1
*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.3,4 
†Patients were asked about their medical comorbidities diagnosed in the 12 months prior to IBRANCE initiation.2
‡Data for patients with metastatic disease only.1
§Defined as having metastases to the lungs, brain, liver or ovaries.1

ABC = advanced breast cancer; AI = aromatase inhibitor; ECOG PS = Eastern Cooperative Oncology Group performance status; FUL = fulvestrant; HER2- = human epidermal growth factor receptor 2-negative;  HR+ = hormone receptor-positive; IRIS = the ibrance real world insights; mBC = metastatic breast cancer.


References: 1. Taylor-Stokes G, et al. Breast. 2019;43:22-27. 2. Pfizer Data on file. New York, NY: Pfizer, Inc. 3. Gerstein HC, et al. Lancet. 2019;393(10168):210-211. 4. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868.

Prescribing Information: Master GULF LEVANT-LPD- (Ibrance)- Capsules- 75 mg, 100 mg &125 mg based on USPI Revision date: December 2022 – United Arab Emirates

PP-IBR-ARE-0144

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