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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-3 Study DesignA randomised, double-blind, placebo-controlled, Phase III study to assess the efficacy of IBRANCE in combination with fulvestrant in pre-/peri- and post-menopausal women with HR+/HER2- ABC who had progressed on or after prior ET.1Adapted from Cristofanilli M, et al. 2016.1
*Defined as progression during or within 1 month after the end of prior ET in the context of metastatic disease or progression during or within 12 months after discontinuation of adjuvant ET. 21% of patients had not received prior treatment for their metastatic disease (first-line). Pre-/peri-menopausal patients received the LHRH agonist goserelin for at least 4 weeks prior to and for the duration of the trial.1
Sensitivity to prior hormonal therapy was defined as documented clinical benefit (CR, PR or SD ≥24 weeks) to ≥1 prior hormonal therapy regimen in the metastatic setting or ≥24 months of adjuvant hormonal therapy before recurrence.1
Evaluated according to RECIST Version 1.1.1
§ORR was defined as confirmed CR or PR.1
||CBR was defined as CR or PR or SD for ≥24 weeks.1

ABC = advanced breast cancer; CBR: clinical benefit response; CR: complete response; DOR: duration of response; ET = endocrine therapy; HER2- = human epidermal growth factor receptor 2-negative; HR+= hormone receptor-positive;
LHRH = luteinising hormone-releasing hormone; ORR: overall response rate; OS: overall survival; PR: partial response; PALOMA-3: the palbociclib ongoing trials in the management of breast cancer 3; PFS= progression-free survival;
RECIST= Response Evaluation Criteria in Solid Tumours; SD= stable disease.

Reference: 1. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.
PALOMA-3 Baseline CharacteristicsAdapted from Cristofanilli M, et al. 2016.1
Data cut-off date: 16 March 2015. Data are number (%), unless otherwise specified. Because of rounding off, some percentages do not total 100% when summed.
*Data were unavailable for 1 patient in the ITT fulvestrant + placebo group.1
DFI was defined as the time taken from diagnosis of primary breast cancer to first relapse in patients who received adjuvant therapy. Data for DFI were available only for patients who were initially diagnosed with early breast cancer and then experienced disease relapse; percentages are calculated on the basis of available data.1
Patients did not receive chemotherapy in the context of metastatic disease.
§Previous sensitivity to ET was based on randomisation.
*Per protocol, visceral refers to lung, liver, brain, pleural and peritoneal involvement, and was a study stratification factor.1
*For classification of receptor status (≥median of distribution, <median of distribution), the H-score was used. The median was calculated on the basis of the number of patients who were tested by the central laboratory (250 patients in the fulvestrant plus
palbociclib group and 130 patients in the fulvestrant plus placebo group).

ECOG = Eastern Cooperative Oncology Group; FUL = fulvestrant; ITT = intention-to-treat; PALOMA-3: the palbociclib ongoing trials in the management of breast cancer 3 PLA = placebo. ABC = advanced breast cancer; DFI = disease-free interval; ET = endocrine treatment; mBC = metastatic breast cancer; SD = standard deviation

Reference: 1. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439

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


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