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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 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
RWE in older patients with mBC

A challenge when treating older patients is the lack of evidence to inform delivery of cancer care due to their under-representation in clinical trials. RWE may provide valuable information to supplement available data on efficacy and safety of treatment in this heterogeneous patient group.¹

In real-world studies, older patients with HR+/HER2- mBC derived clinical benefit from IBRANCE combined with ET treatment compared with ET alone.2-4

FLATIRON Database real-world PFS and OS in older patients

When analyzed by age group, median rwPFS and median OS remained longer in patients who received IBRANCE in combination with letrozole versus letrozole alone in both the 65–74 and the ≥75-years-old age groups.² 

PalomAGE Cohort B: QoL in women aged ≥705

In women with resistant and/or pre-treated mBC, global QoL was maintained at 6 months.5

Following 6 months of IBRANCE treatment, a clinically meaningful reduction in pain scores was observed (≥10 points). No clinically meaningful changes occurred in other domains and scales.5

PaloMAGE toxicities6,7

The toxicity profile for older patients treated with IBRANCE was consistent with that seen in clinical trials.6,7 No new safety signals were detected.6

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.Explore More IBRANCE dosing Explore more LoadingCI = confidence interval; ET = endocrine therapy; HR = hazard ratio; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; LET = letrozole; mBC = metastatic breast cancer; MedDRA = Medical Dictionary for Regulatory Activities; NE = not estimable; OS = overall survival; PFS = progression-free survival; QoL = quality of life; RWE = real-world evidence; rwPFS = real-world progression-free survival; sIPTW = stabilized inverse probability of treatment weighting.References:Habr D, et al. J Natl Cancer Inst. 2021;113:1460-1464.Rugo HS, et al. ESMO 2021. Poster 236P.Clifton K, et al. Breast Cancer Res Treat. 2019;175:667-674.El Badri S, et al. Breast. 2021;60:199-205.Brain E, et al. SABCS 2021. Poster P1-18-04.Caillet P, et al. Oral presentation at ASCO 2021.Rugo HS, et al. Eur J Cancer. 2018;101:123-133.
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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