CDK4/6 Inhibitors in Breast Cancer:

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Presentation transcript:

CDK4/6 Inhibitors in Breast Cancer:

CDK4/6 Inhibitors in Breast Cancer

Dysregulation of the CDK4/6 Pathway

CDK4/6 Inhibitors in Clinical Development

Preclinical Data Using Palbociclib

Preclinical Data Using Ribociclib

Abemaciclib Is a Selective Inhibitor of CDK4/6

PALOMA-2: Study Design

PALOMA-2 PFS: Investigator-Assessed ITT Population

PALOMA-2 PFS Subgroup Analysis-ITT, Investigator Assessment

MONALEESA-2: Primary Endpoint Was Met Early

PALOMA-3: PFS

PALOMA-3: Postprogression Therapies

Consistent Clinical Benefit Seen Across PALOMA Studies

MONARCH 1: Disease and Patient Characteristics

MONARCH 1: Prior Therapies

MONARCH 1: Response Summary

MONARCH 1: Treatment Duration

Activity of Chemotherapy in Taxane-Treated MBC

MONARCH 1: Conclusions

MONALEESA-2: Hematological AEs

Palbociclib-Induced Neutropenia Is Reversible, But Chemotherapy-Induced Neutropenia Is Not

MONARCH 1: Most Common AEs

PALOMA-3: Global QoL, Functioning, and Symptoms

Palbociclib Approval by EMA: November 10, 2016

MBC: Therapy Strategies

Phase 2 neoMONARCH: Study Design

Ki67 Expression and Response at Week 2

neoMONARCH RECIST Response Data Over Time

CDK4/6 Inhibitors in Early Breast Cancer: Adjuvant Trials

CDK4/6 Inhibitors in Breast Cancer: Summary

CDK4/6 Inhibitors in Breast Cancer: Summary (cont)

CDK4/6 Inhibitors in Breast Cancer: Summary (cont)

Looking Forward

Abbreviations

Abbreviations (cont)

Abbreviations (cont)