ADJUVANT TRIAL OUTCOMES


The APHINITY trial demonstrated significant improvement vs the standard of care in the overall study population.1

The APHINITY trial evaluated adjuvant patients with a range of high-risk features1,2

iDFS: ITT population (primary endpoint)1*

PERJETA + Herceptin-based therapy provided a statistically significant improvement in iDFS vs placebo and Herceptin-based therapy.1

Patients in the APHINITY trial received PERJETA or placebo + Herceptin-based therapy for a total of 1 year (up to 18 cycles), or until recurrence, withdrawal of consent, or unmanageable toxicity.

iDFS from APHINITY (ITT population)1

*iDFS was defined as time from randomization to first occurrence of ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.1
After a median follow-up of 45.4 months. All analyses stratified by nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen.1

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

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)

Exploratory analysis: node-positive disease

23% reduction in the risk of recurrence in the node-positive subgroup1,2

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

There was an inability to show a reduction in risk of recurrence for the node-negative subgroup.1,2

Exploratory analysis: iDFS in node-positive and -negative subgroups1

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

Exploratory analysis: hormone receptor–negative disease

24% reduction in the risk of recurrence in the hormone receptor–negative subgroup1,2

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

Exploratory analysis: iDFS in the hormone receptor–negative and –positive subgroup1

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

Exploratory analysis: adjuvant chemotherapy regimen

iDFS in the anthracycline and non-anthracycline subgroups.1

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

References