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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
PALOMA-3 overall survival (secondary endpoint) In PALOMA-3, OS results demonstrated a numerical, but non-statistically significant difference, in favour of IBRANCE3

The PALOMA-3 OS final analysis of IBRANCE in combination with fulvestrant in 1st line or later demonstrated a numerical difference in favour of IBRANCE in combination with fulvestrant vs placebo + fulvestrant that did not reach statistical significance1,2

The difference in median OS with IBRANCE in combination with fulvestrant (not statistically significant)1 was similar to the improvement in mPFS previously seen with the addition of IBRANCE to fulvestrant in PALOMA-31,3

PALOMA-3 OS Kaplan-Meier Curve1,2

Adapted from IBRANCE SmPC2 and Turner NC, et al. 2018.1
Data cut-off date: April 13, 2018.

* Not statistically significant at the prespecified significance level of 0.0235 (1-sided).2 
† 1-sided p-value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior endocrine therapy per randomisation.2

The final updated non-prespecified OS analysis demonstrated a numerical difference in mOS in favor of IBRANCE + fulvestrant, at >6 years median follow-up.⁴

Data cut-off date: August 17, 2020. 

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PALOMA-2

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CI = confidence interval; ET = endocrine therapy; FUL = fulvestrant; HR = hazard ratio; HR+/HER2- = hormone receptor-positive/human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer; n = number of patients; OS = overall survival; PLA = placebo; SmPC = Summary of Product Characteristics.
References:Turner NC, et al. N Engl J Med. 2018;379(20): 1926-1936.IBRANCE Summary of Product Characteristics.Cristofanilli M, et al. ASCO 2021; Oral presentation 1000.Cristofanilli et al. Clin Cancer Res; 28(16) August 15, 2022.
PALOMA-3 IBRANCE in the real-world setting

Discover how patients responded to IBRANCE combination therapy in the real-world setting

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IBRANCE Summary of Product Characteristics Product Characteristics Loading

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