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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
In the real-world setting, the majority of patients did not require dose adjustment for the duration of therapy, regardless of starting dose*1- The IRIS (IBRANCE real-world insights) 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:
  • 19.7% and 14.4% of patients treated with IBRANCE + AI and IBRANCE + fulvestrant, respectively, had a dose adjustment†1
  • 77.5% and 72.9% of patients initiated IBRANCE at the 125 mg/day dose in combination with an AI and fulvestrant, respectively†1
  • 5.6% of patients receiving IBRANCE + AI in first-line and 10.3% of those receiving IBRANCE + fulvestrant in first or later-line discontinued treatment for reasons other than disease progression†1
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.2,3
†Rates of dose adjustment or discontinuation may differ from those in clinical trials or other real-world data studies partly due to differences in the percentage of patients that started at doses other than 125 mg/day.1 The recommended starting dose of IBRANCE per the approved EU SmPC is 125 mg taken daily, 3 weeks on, 1 week off.4

ABC = advanced breast cancer; AI = aromatase inhibitor; FUL = fulvestrant; HER2- = human epidermal growth factor receptor 2-negative; HR+ = hormone receptor-positive; mBC = metastatic breast cancer.

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. 4. Master Gulf Levant-LPD-(Ibrance)-Capsules - 75 mg, 100 mg & 125 mg based on USPI date of Revision: December 2022 for UAE.In the real world, IBRANCE benefits met or exceeded the expectations of most patients*1Observational, cross-sectional, web-based survey of 604 women in the United States (n = 250), Canada (n = 100), Germany (n = 100), the Netherlands (n = 52), Argentina (n = 51) and Denmark (n = 51) with self-reported HR+/HER2- ABC/mBC, using the CTSQ†1:
  • Expectations‡ of therapy were neutral to high in the majority (90.1%) of patients, with a mean score of 71.8§
  • Expectations of therapy domain scores were generally consistent across treatment groups
  • 96.4% of patients felt that the benefits of IBRANCE met or exceeded expectations‡ ||
Adapted from Darden C, 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.2,3
†Patients self-selected to participate in research studies. Invitations were distributed to research panel members who had a self-reported physician diagnosis of breast cancer. Therefore, the panel population and those who agreed to participate in this study may not be representative of the overall ABC/mBC population. Patient-reported treatment satisfaction was assessed using a 38-item questionnaire that included screener questions to confirm eligibility, an informed consent and the CTSQ, which assesses 3 domains: expectations of therapy in preventing recurrence or progression or returning to normal life, feelings about side effects and satisfaction with therapy. Each domain is scored from 0 to 100, with a higher score indicating better outcomes.1
‡Expectations reflect patient perception of what the potential impact of therapy could be and not verified clinical effects.1
§Based on item 1 of the CTSQ of the therapy domain, which included the following items: return back to a normal life, get rid of the cancer, prevent cancer from coming back, stop the cancer from spreading and help you live longer.1
||Based on Item 12 of the CTSQ (Satisfaction With Therapy domain).1
ABC = advanced breast cancer; AI = aromatase inhibitor; CTSQ = cancer therapy satisfaction questionnaire; FUL = fulvestrant; HER2- = human epidermal growth factor receptor 2-negative; HR+ = hormone receptor-positive; mBC = metastatic breast cancer.

References: 1. Darden C, et al. Future Oncol. 2019;15(2):141-150. 2. Gerstein HC, et al. Lancet. 2019;393(10168):210-211. 3. 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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