ADJUVANT TRIAL OUTCOMES


iDFS: ITT population (primary endpoint)1

Based on the primary analysis, dual anti-HER2 adjuvant therapy with PERJETA + Herceptin® (trastuzumab) + chemotherapy vs placebo + Herceptin + chemotherapy demonstrated a reduction in the risk of recurrence in patients with HER2+ early breast cancer (EBC).*

*Recurrence is defined as an invasive disease event or death
All analyses stratified by nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen.
iDFS=invasive disease-free survival.

Primary analysis with 3-year data

Select Important Safety Information: Left Ventricular Dysfunction

  • Assess LVEF prior to initiation of PERJETA and at regular intervals during treatment to ensure that LVEF is within normal limits. If LVEF declines and has not improved, or has declined further at the subsequent assessment, discontinuation of PERJETA and trastuzumab should be strongly considered

Secondary endpoints1

Median follow-up: 45.4 months (primary analysis)

PERJETA + Herceptin + chemotherapy vs placebo + Herceptin + chemotherapy

  • iDFS including second primary nonbreast cancer: HR=0.83, 95% CI: 0.68-1.00
    • 3-year event-free rate: 93.5% (95% CI: 92.5-94.5) vs 92.5% (95% CI: 91.4-93.6)
  • DFS: HR=0.82, 95% CI: 0.68-0.99
    • 3-year event-free rate: 93.4% (95% CI: 92.4-94.4) vs 92.3% (95% CI: 91.2-93.4)
  • OS: HR=0.89, 95% CI: 0.66-1.21
    • 3-year event-free rate: 97.7% (95% CI: 97.0-98.3) vs 97.7% (95% CI: 97.1-98.3)

The APHINITY trial evaluated adjuvant patients with a range of high-risk features1,3

Exploratory analysis: iDFS by patient subgroup¶1,2

Exploratory analyses without adjusting for multiple comparisons; therefore, results are considered descriptive.

Nodal status

Hormone receptor status

Chemotherapy regimen

Summary

References