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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
PALOMA-2 Study DesignA randomised, double-blind, placebo-controlled, Phase III efficacy study to assess the safety and efficacy of IBRANCE in combination with letrozole as first-line treatment of postmenopausal women with ER+/HER2- ABC1Adapted from Finn RS, et al. 2016.1
*Evaluated according to RECIST Version 1.1.1
†ORR was defined as confirmed CR or PR.1
‡CBR was defined as confirmed CR, PR or SD for ≥24 weeks.1
ABC = advanced breast cancer; CBR= Clinical benefit response; CR= complete response; DOR= duration of response; DFI = disease-free interval; ER+= oestrogen receptor-positive; HER2-= human epidermal growth factor receptor 2-negative;
ORR= overall response rate; OS= overall survival; PALOMA-2= letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; PFS = progression-free survival; PR= partial response; QTc = QT interval corrected for heart rate; RECIST= Response Evaluation Criteria in Solid Tumours; SD= stable disease.
Reference: 1. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.PALOMA-2 Baseline CharacteristicsAdapted from Finn RS, et al. 2016.1
Data cut-off date: 26 February 2016. Some percentages do not sum to 100 because of rounding off.
*DFI was defined as the time from adjuvant or neoadjuvant therapy to recurrence. Newly metastatic disease applies to patients who had not received any prior systemic therapy, for whom a determination of DFI was not possible.1
†Patients who received anastrozole or letrozole as a component of their adjuvant or neoadjuvant therapy were excluded from the study if they had disease progression while receiving the therapy or within 12 months after completing the therapy.1


DFI= disease-free interval; ECOG= Eastern Cooperative Oncology Group; LET= letrozole; PLA= placebo.

Reference: 1. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.PALOMA-2 Baseline CharacteristicsAdapted from Finn RS, et al. 20161; Rugo H, et al. 2019.2
*Evaluated according to RECIST Version 1.1.1
†Data cut-off date: 26 February 2016.1
‡Data cut-off date: 31 May 2017. Updated follow-up of the primary analysis of PALOMA-2: 37.6 months in the IBRANCE + LET arm.2

CI = confidence interval; ER+= oestrogen receptor-positive; HER2- = human epidermal growth factor receptor 2-negative; HR = hazard ratio; LET = letrozole; mBC = metastatic breast cancer; mPFS = median progression-free survival; NE = not estimable;
OS = overall survival; PALOMA-2: letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; PFS = progression-free survival; PLA = placebo; RECIST = Response Evaluation Criteria in Solid Tumors.

References: 1. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936. 2. Rugo HS, et al. Breast Cancer Res Treat. 2019;174(3):719-729.

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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