KADCYLA efficacy: Nearly 90% of patients remained disease free at 3 years1

KATHERINE trial overview1,2

  • Randomized, open-label trial of 1486 patients with HER2+ EBC who had residual invasive disease in the breast and/or axillary lymph nodes following neoadjuvant treatment with taxane + trastuzumab-based therapy
  • Designed to assess efficacy and safety of KADCYLA vs Herceptin® (trastuzumab) in the adjuvant setting
  • Administered every 3 weeks for a total of 14 cycles or until recurrence, withdrawal of consent, or unmanageable toxicity
  • The primary endpoint was invasive disease-free survival (iDFS), defined as the time from randomization to first occurrence of ipsilateral invasive breast tumor recurrence, ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause
  • The majority of patients in the trial (71.4% of 740) completed all 14 cycles of KADCYLA treatment2

iDFS in the overall study population after a median follow-up of 40 months1

3-year iDFS rates were 88.3% for KADCYLA vs 77.0% for Herceptin1

*Recurrence is defined as an invasive-disease event or death.

NCCN Guidelines® Recommended Option4

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend ado-trastuzumab emntansine (KADCYLA) monotherapy for the adjuvant treatment of patients with HER2+ breast cancer with residual invasive disease after neoadjuvant treatment (category 1, preferred)

  • NCCN Guidelines recommend treatment with ado-trastuzumab emntansine (KADCYLA) for 14 cycles in this setting

Category 1: Based upon high-level evidence, there is uniform National Comprehensive Cancer Network® (NCCN®) consensus that the intervention is appropriate. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

Consistent iDFS benefit was observed with KADCYLA across subgroups1

Based on stratification factors, key baseline demographics and disease characteristics, and prior treatments1

Exploratory analysis of select pre-specified subgroups2

Five patients with a ypT1 tumor stage had ypT1 disease without further subspecification.2
§18.3% (n=272) of patients were treated with PERJETA® (pertuzumab) + Herceptin-based therapy in the neoadjuvant setting, and had an iDFS hazard ratio of 0.50 (95% CI 0.25-1.00). The other 18 patients received Herceptin and either neratinib, dacomitinib, afatinib, or lapatinib.2

How KADCYLA was studied

Review the adverse reactions

Dosing for KADCYLA in EBC