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Clinical efficacy & safetyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-2 summaryPALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)SafetySafety overviewPooled ARsPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresIBRANCE long-term safetyGI and liver toxicitiesEffect of IBRANCE on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyRW evidenceValue of RWEWhat is real-world evidence?What is the value of RWE?P-REALITY and P-REALITY XP-REALITY OverviewP-REALITY OS and rwPFSP-REALITY X OverviewP-REALITY X OS and rwPFSIRISIRIS OverviewIRIS PFS and OSPOLARIS POLARIS OverviewPOLARIS Patient-Reported OutcomesMADELINEMADELINE OverviewMADELINE Patient CharacteristicsMADELINE Patient-Reported OutcomesPalomAGEPalomAGE OverviewRWE in Older Patients with mBCPatient-reported outcomesPALOMA-2: FACT-B scoresPALOMA-3: EORTC QLQ-C30 scoresPALOMA-3: Time to deterioration in pain symptomsDosingRecommended dosing scheduleRecommended dose modifications for AEsMonitoringOne scheduled monitoring provision ResourcesMaterials
P-REALITY X OS and rwPFS

Median OS (primary endpoint) was longer among patients who received IBRANCE + AI vs AI alone before adjustment (HR=0.67; p<0.0001) and after sIPTW (HR=0.76; p<0.0001) and PSM adjustment (HR=0.72; p<0.0001)1

P-REALITY X mOS*

Adapted from Rugo H, et al. 2022.1OS was defined as the time in months from the start of study treatment until death.¹ 

IBRANCE + AI was associated with a significantly prolonged median OS vs AI alone, resulting in a 24% reduction in risk of death (in sIPTW analysis); HR=0.76 (95% CI: 0.65–0.87; p<0.0001)1

PALOMA-2 did not meet the secondary endpoint of OS (prespecified HR≤0.74)1

Median rwPFS (secondary endpoint) was significantly longer among patients who received IBRANCE + AI vs AI alone before (HR=0.68; p<0.0001) and after sIPTW (HR=0.70; p<0.0001) and PSM adjustment (HR=0.72; p<0.0001) 

P-REALITY X rwPFS1*

Adapted from Rugo H, et al. 2022.1rwPFS was defined as the number of months from the start of treatment with IBRANCE + AI or AI alone to the date of the first documentation of disease progression by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment or death due to any cause, whichever occurred first. 
IBRANCE + AI was associated with a significantly prolonged median rwPFS vs AI alone, resulting in a 30% reduction in risk of real-world disease progression (in sIPTW analysis); HR=0.70 (95% CI: 0.62–0.78; p<0.0001)1Observational 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 Explore More IRIS overview Explore more Loading P-REALITY X OS and rwPFS Explore more LoadingAI = aromatase inhibitor; CI = confidence interval; HR = hazard ratio; N/n = number of patients; PFS = progression-free survival; PSM = propensity score matching; rwPFS = real-world progression-free survival; sIPTW = stabilized inverse probability treatment weighting.

References:

Rugo HS, et al. NPJ Breast Cancer. 2022;8(1):114.Gerstein HC, et al. Lancet. 2019;393(10168):210-211. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868.P-REALITY and P-REALITY X
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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