KADCYLA clinical trial results

Proven survival benefit in the EMILIA trial

EMILIA trial overview1

  • 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

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

Demonstrated survival benefit for patients regardless of hormone status1

  • 28% reduced risk of progression or death with KADCYLA in the hormone-positive subgroup (n=545; HR for PFS=0.72; 95% CI: 0.58, 0.91)
  • 38% reduced risk of death with KADCYLA in the hormone-positive subgroup (n=545; HR for OS=0.62; 95% CI: 0.46, 0.85)

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

Shown to shrink tumors in more patients1

  • More patients had a complete response (1.0% vs 0.5%) or partial response (42.6% vs 30.3%) with KADCYLA than with lapatinib + capecitabine

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 1.1.9-11

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)

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.9

How KADCYLA was studied

Find out more about the EMILIA clinical trial design.

KADCYLA safety profile

Understand the adverse reactions.

KADCYLA Access Solutions

Genentech offers options to help eligible patients with the out-of-pocket (OOP) costs of their Genentech medicines.