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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
PALOMA-2 progression-free survival

In PALOMA-2, IBRANCE in combination with letrozole delivered >2 years mPFS in 
1st line1,2 with 37.6 months of clinical trial follow-up2

PALOMA-2 PFS* Kaplan-Meier Curve1​​​​​​​

In a 2:1 randomised, double-blind, Phase III trial of post-menopausal women with ER+/HER2- mBC (N=666)1

35.7 months of mPFS with IBRANCE + letrozole (95% CI: 27.7–38.9) vs 19.5 months with placebo + letrozole (95% CI: 16.6–26.6) in a blinded independent central review (HR=0.611; 95% CI: 0.485–0.769)2

Adapted from Finn RS, et al. 20161 and Rugo H, et al. 2019.²
*Evaluated according to RECIST Version 1.1.1 †Data cut-off date: February 26, 2016. ‡Data cut-off date: May 31, 2017.
 Updated follow-up of the primary analysis of PALOMA-2: 37.6 months in the IBRANCE + LET arm.2

This benefit was seen across a broad range of women

In an updated non-prespecified subgroup analysis, IBRANCE in combination with letrozole extended mPFS across the 1st line post-menopausal patient subgroups studied vs placebo+ letrozole:²*

Subgroups included:
  • Elderly patients (≥65 years)
  • Patients with visceral disease
  • Patients with bone-only disease
PALOMA-2 Updated Non-prespecified Subgroup Analysis2Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur neque tellus, elementum sit amet lectus id, congue varius elit. Fusce molestie urna id elit fermentum tincidunt. Proin vel nibh sed elit commodo efficitur nec nec ipsum. Aliquam erat volutpat. Suspendisse eu elit et nisi malesuada luctus. Phasellus nec velit dapibus, condimentum purus non, rutrum mi. In eros sem, pellentesque id congue mollis, vehicula sit amet neque. Quisque condimentum feugiat quam non rhoncus. Cras eget vestibulum urna. Nullam sodales ipsum elit, ac commodo odio fringilla at.Adapted from Rugo H, et al. 2019.²
Updated follow-up of the primary analysis of PALOMA-2: 37.6 months in the IBRANCE + LET arm at data cut-off date of May 31, 2017.1-sided P-value from the log-rank test.² Per tumour site.² TFI was defined as the time from the end of (neo)adjuvant therapy to disease progression.² A few patients initially enrolled as having measurable disease were later found to have non-measurable disease beyond bone-only disease.²

*Evaluated according to RECIST Version 1.1.¹

Explore More PALOMA-3

See PALOMA-3 progression-free survival data

 Learn more
BICR = blinded independent central review; Cl = confidence interval; ECOG = Eastern Cooperative Oncology Group;ET= endocrine therapy; HR = hazard ratio; ER+/HER2- = estrogen receptor-positive, human epidermal growth factor receptor 2-negative; IA = investigator assessed; LET = letrozole; mBC = metastatic breast cancer; mPFS = median progression-free survival; N/n = number of patients; NE= not estimable; PFS = progression-free survival; PLA = placebo; RECIST = Response Evaluation Criteria in Solid Tumors; TFI = treatment-free interval.References:Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936. 
Rugo H, et al. Breast Cancer Res Treat. 2019;174(3):719-729.
PALOMA-2 P-REALITY real-world study

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

 Find out more
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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