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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
Safety Profile

Confidence In A Treatment You Can Manage1-9

IBRANCE® has a well-characterised and consistent safety profile1-9Overall Adverse Events (AEs) reported with IBRANCE®1* (n=872)
IBRANCE Summary of Product Characteristics Product Characteristics Loading

a Preferred Terms (PTs) are listed according to MedDRA 17.1.

Infections includes all PTs that are part of the System Organ Class Infections and infestations.

Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.

Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.

Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.

f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.

Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.

Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.

ILD/pneumonitis includes any reported PTs that are part of the Standardised MedDRA Query Interstitial Lung Disease (narrow).

Venous Thromboembolism includes the following PTs: pulmonary embolism, embolism, deep vein thrombosis, peripheral embolism, thrombosis

* Adverse Drug Reaction (ADR) identified post-marketing.

IBRANCE Summary of Product Characteristics Product Characteristics Loading
Most Frequent Adverse Events of Any Grade (n=872)

The most frequent (≥20%) Adverse Events of any grade observed across the PALOMA Clinical Trial Programme were:1†a

In all grades

a PTs : Are listed according to MedDRA 17.1.
* Adverse Drug Reaction (ADR) : Identified post-marketing.
† Based on pooled data from 872 patients who received IBRANCE® in combination with ET (n=527 in combination with letrozole and n=345 in combination with fulvestrant) in three randomised clinical studies in HR+/HER2- advanced or mBC1

IBRANCE® Most Common Grade >3 Adverse Reactions ILD/Pneumonitis

Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea). In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE® immediately and evaluate the patient. Permanently discontinue IBRANCE® in patients with severe ILD or pneumonitis. Severe, life-threatening, or fatal ILD and/or pneumonitis can occur in patients treated with IBRANCE when taken in combination with endocrine therapy. Across clinical studies (PALOMA-1, PALOMA-2, PALOMA-3), 1.4% of IBRANCE-treated patients had ILD/pneumonitis of any grade.1

Venous Thromboembolism

VTEs were reported in 3.2% of patients treated with IBRANCE across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3). Patients should be monitored for signs and symptoms of DVT and PE, and treated as medically appropriate.1

For the most up to date safety profile information and guidance on the management of treatment related adverse events, please refer to the full IBRANCE® Summary of Product Characteristics.

AE : Adverse Event, ALT : Alanine aminotransferase, AR : Adverse Reaction, AST : Aspartate aminotransferase, DVT: Deep Vein Thrombosis, ET : Endocrine Therapy, HR+/HER2– : Hormone Receptor Positive / Human Epidermal growth factor Receptor 2 Negative, ILD : Interstitial Lung Disease, mBC : metastatic Breast Cancer, MedDRA : Medical Dictionary for Regulatory Activities, N/n : Number of patients, NA : Not Applicable PE: Pulmonary Embolism, PTs : Preferred Terms VTE: Venous Thromboembolic Event

References

IBRANCE® Summary of Product Characteristics.

Finn RS, et al. N Engl J Med. 2016;375:1925-1936.Cristofanilli M, et al. Lancet Oncol. 2016;17:425–39.Verma S, et al. Oncologist. 2016;21:1165-1175.Diéras V, et al. J Natl Cancer Inst. 2019;111(4):419-430.Diéras V, et al. Oncologist. 2019;24(12):1514-1525.Turner NC et al. N Engl J Med. 2018;379:1926–36.Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29.Finn RS, et al. Oral presentation LBA1003. ASCO 2022.

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Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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