CDK4/6 Inhibition Plus Aromatase Inhibition in Advanced Breast Cancer

PALOMA-2 Phase III Trial Results

• June 20, 2016

Palbociclib (Ibrance, CDK4/6 inhibitor) combined with letrozole demonstrated superior efficacy versus letrozole monotherapy in first-line treatment of ER+/HER2- advanced breast cancer in postmenopausal women.

Key Efficacy Data

Progression-Free Survival:

• Palbociclib + Letrozole: 24.8 months
• Placebo + Letrozole: 14.5 months
• 42% risk reduction (p<0.000001)

Objective Response Rate:

• Combination: 85%
• Letrozole alone: 70% (p<0.0001)

Safety Profile

Common Grade 3-4 adverse events: neutropenia (6%), fatigue (28%), nausea (26%), arthralgia (34%), alopecia (16%)

Clinical Conclusion

Palbociclib plus letrozole combination represents an effective first-line standard for postmenopausal women with ER-positive advanced breast cancer.

Data Source

PALOMA-2: Phase III trial of palbociclib with letrozole versus letrozole alone in postmenopausal women with ER+/HER2– advanced breast cancer. ASCO 2016, Abstract 706.

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Related Cancer Information

• Breast cancer