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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
IBRANCE has a well-characterised and consistent safety profile1-6PALOMA trials Pooled Dataset (N=872): Grade 3 or 4 Adverse Reactions

Dose reductions or modifications and discontinuation rates across the PALOMA trials:1,5

  • In an early pooled analysis of PALOMA trials, 38.4% of patients receiving IBRANCE had dose reductions or modifications due to any ARs and 5.2% permanently discontinued treatment, regardless of the combination¹
    In an updated pooled safety analysis of PALOMA trials up to 5 years, 41.1% of patients receiving IBRANCE had ≥1 dose reduction and 11.1% permanently discontinued treatment due to ARs⁵
NeutropeniaLimited or no correlation between neutropenia and viral infections

In a long-term pooled analysis, overlapping of viral infections (all grades) and Grade ≥3 neutropenia occurred in 10.5% of patients treated with IBRANCE, with 99.8% of viral infections being Grade 1/2. Overlapping Grade ≥3 viral infections occurred in only 0.2% of patients with Grade ≥3 neutropenia*5

Febrile neutropenia

Febrile neutropenia has been reported in about 2% of patients exposed to IBRANCE in a pooled analysis of PALOMA trials1

Discontinuation rates due to neutropenia

In a pooled analysis of the PALOMA trials up to 5 years:5

  • 1.7% of patients permanently discontinued treatment due to neutropenia
Neutropenia can be managed by dose delay or modification without an apparent effect on efficacy

In two exploratory analyses from PALOMA-2 and -3, dose reductions did not appear to have an effect on efficacy4,6

*Patients who have additional risk factors that make them susceptible to infection (e.g., elderly, weakened immune systems) should be carefully monitored for signs of infection.5 As per the IBRANCE SmPC, patients should be monitored for signs and symptoms of infection and treated as medically appropriate.¹Explore More PALOMA pooled adverse reactions

Consistent safety profile

 Learn more PALOMA pooled laboratory abnormalities

Consistent safety profile

 Learn more
​​​​​​​AE = adverse event; AR = adverse reaction; ALT = alanine aminotransferase; AST = aspartate aminotransferase; SmPC = Summary of Product Characteristics; mBC = metastatic breast cancer.References:IBRANCE Summary of Product Characteristics.Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.Verma S, et al. Oncologist. 2016;21:1165-1175.Finn R.s. et al. The Oncologist 2021;26:e749–e755.Diéras V, et al. Oncologist. 2019;24(12):1514-1525.
Safety Dose modification

Effect on efficacy

 Find out more
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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