KADCYLA efficacy: provided proven survival benefit in OS and PFS1

EMILIA trial overview1

  • Randomized, open-label trial of 991 patients with locally advanced or metastatic HER2-positive (HER2+) breast cancer
  • Designed to assess efficacy and safety of KADCYLA vs lapatinib + capecitabine
  • All treatments administered in 3-week cycles

Learn more about the EMILIA trial design here.

Extended median overall survival (OS) by nearly 6 months1

  • 30.9 months median OS with KADCYLA vs 25.1 months with lapatinib + capecitabine
EMILIA OS results: HR=0.682; 95% CI: 0.548-0.849; P=0.0006

Significantly improved progression-free survival (PFS)1

  • Patients treated with KADCYLA had more time without disease progression (HR=0.650; 95% CI: 0.549, 0.771; P<0.0001)
  • 9.6 months median PFS with KADCYLA vs 6.4 months with lapatinib + capecitabine
EMILA PFS results: HR=0.650; 95% CI: 0.549-0.771; P<0.0001

KADCYLA demonstrated prolonged survival benefit across select subgroups vs lapatinib + capecitabine1

Regardless of hormone receptor status (ER/PR+ and ER/PR-), KADCYLA provided survival benefit over lapatinib + capecitabine1

  • Patients with hormone-receptor positive tumors who took KADCYLA had a 28% reduction in the risk of progression or death and a 38% reduction in the risk of death (n=545; HR for PFS=0.72; 95% CI: 0.58, 0.91; HR for OS=0.62; 95% CI: 0.46, 0.85)
PFS and OS for select patient subgroups/hormone receptor status

CI=confidence interval; ER=estrogen receptor; HR=hazard ratio; PR=progesterone receptor.

Tumor response with KADCYLA surpassed lapatinib + capecitabine1

Shown to shrink tumors in more patients1

  • Patients treated with KADCYLA had a higher partial response (42.6% vs. 30.3%) than lapatinib + capecitabine; complete response was 1% and 0.5%, respectively
EMILIA secondary endpoint: Objective response rate (ORR)

ORR defined as the proportion of patients who achieved a complete response (disappearance of all target tumors) or a partial response (≥30% decrease in the sum of the longest diameters of target tumors) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.3,5,6

Nearly doubled the median duration of response (DoR)1

  • 6.1 months improvement in median DoR was demonstrated (12.6 months vs 6.5 months with lapatinib + capecitabine)
EMILIA secondary endpoint: Duration of response (DOR)

DoR defined as the time from initial documented tumor response (complete or partial) until documented disease progression. Only patients who achieved an initial response were evaluated for DoR.3

How KADCYLA was studied

Review the adverse reactions

Financial Assistance