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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-2 overall survivalPatients receiving IBRANCE in combination with letrozole had a numerically longer OS compared to placebo plus letrozole, but the results were not statistically significant1PALOMA-2 OS Kaplan-Meier curve1In a 2:1 randomised, double-blind, Phase III trial of post-menopausal women with ER+/HER2- mBC (N=666)1

With a median follow-up of 7.5 years, median OS was 53.9 months (95% CI: 49.8–60.8) in the IBRANCE + letrozole arm vs 51.2 months (95% CI: 43.7–58.9) in the placebo + letrozole arm (HR=0.96; 95% CI: 0.78–1.79; p=0.3378)1

Adapted from data on file.1Data cut-off date: November 15, 2021.1
Final overall survival (secondary endpoint) analysis of PALOMA-2.1PALOMA-2 did not meet the secondary endpoint of OS (prespecified HR≤0.74)There was an 80% power to detect an OS difference between treatment arms with an HR of ≤0.74¹

Interpretation of OS in PALOMA-2 is limited by the large and disproportionate censoring of patients with missing survival data between treatment arms¹
  • A proportion of patients were no longer being followed up for survival¹
  • In the ITT analysis 21% of patients in the placebo + letrozole arm vs 13% of patients in the IBRANCE + letrozole arm were no longer being followed up for survival1
  • Patients who were no longer being followed for survival were censored at the last known date to be alive1
PALOMA-2 OS Kaplan-Meier curve excluding patients no longer being followed for survival1

In a post-hoc sensitivity analysis excluding LTFU patients, mOS with IBRANCE + letrozole was 51.6 months (95%CI: 46–57.1) vs 44.6 months with placebo + letrozole (95% CI: 37.0–52.3)1

Adapted from data on file.1Data cut-off date: November 15, 2021.1
Post-hoc sensitivity analysis excluding LTFU patients from PALOMA-2.1Statistical procedures controlling for type 1 error were not prespecified1Explore More PALOMA-3

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ITT = intent-to-treat; LTFU = lost to follow up; OS = overall survival.References:Finn RS, et al. J Clin Oncol 40, 2022 (suppl 17; abstr LBA1003)
PALOMA-2 PALOMA-3

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IBRANCE Summary of Product Characteristics Product Characteristics Loading

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