UNDERSTANDING THE RESULTS

What is ENHERTU?

ENHERTU is a prescription medicine used to treat adults who have human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of the body (metastatic), and who have received a prior anti-HER2 breast cancer treatment for metastatic disease, or have breast cancer that has come back during or within 6 months of completing treatment for their early-stage breast cancer.

How was ENHERTU studied in HER2+ mBC?

ENHERTU was studied in many types of adults, including those with different:

  • Ages
  • Hormone receptor (HR) status
  • Tumors that had spread (metastasized) to other parts of the body, including the liver, lungs, and bone
  • Tumors that had spread to the brain and were stable

ENHERTU was compared with Kadcyla® (ado-trastuzumab emtansine) in a clinical trial of 524 people who:

  • Had HER2+ breast cancer that had spread to other parts of their body or could not be removed by surgery, and
  • Had received a prior treatment for HER2+ metastatic breast cancer or had cancer come back during or within 6 months of treatment after surgery

In this trial, 261 people were treated with ENHERTU and 263 were treated with Kadcyla.

What were the results of the ENHERTU study?

Progression-free survival

Initial results (May 2021)

With ENHERTU, people lived longer without their cancer progressing compared to Kadcyla

  • People were 72% more likely to live longer without their cancer progressing compared to Kadcyla
  • In the first assessment, 174 (66.7%) of 261 people treated with ENHERTU lived without their cancer progressing or them dying; 105 (39.9%) of 263 people treated with Kadcyla lived without their cancer progressing or them dying. Median progression-free survival (mPFS) was not reached with ENHERTU, and mPFS for people taking Kadcyla was about 7 months

Updated results (July 2022)

Median progression-free survival with ENHERTU and Kadcyla*†‡

with ENHERTU

and

with Kadcyla

*A median is the middle number in a set of numbers. Median progression-free survival is the length of time from the start of treatment that half of the people in the trial had gone without disease progression or dying.

The updated assessment was not tested for statistical significance and not designed to show differences between treatments. Statistical significance describes a mathematical measure of difference between groups. The difference is statistically significant if it is greater than what might be expected to happen by chance alone.

Based on the updated assessment: 144 (55.1%) of 261 people treated with ENHERTU lived without their cancer progressing or them dying at the time of follow-up; 92 (34.9%) of 263 people treated with Kadcyla lived without their cancer progressing or them dying at the time of follow-up.

Overall survival

Initial results (May 2021)

  • In the first assessment, overall survival results were not available

Updated results (July 2022)

People receiving ENHERTU lived longer compared with people receiving Kadcyla

  • At the time of the follow-up, more than 50% of people receiving ENHERTU or Kadcyla were still alive§
  • ENHERTU reduced the risk of death in patients by 36% vs Kadcyla

Overall survival rates with ENHERTU and Kadcyla||¶

of people were
alive at 24 months
with ENHERTU

and

of people were
alive at 24 months
with Kadcyla

  • 170 (65.1%) of 261 people treated with ENHERTU were alive at the time of follow-up (median follow-up was 28.4 months); and 138 (52.4%) of 263 people treated with Kadcyla were alive at the time of follow-up (median follow-up was 26.5 months)

§At the time of follow-up, since more than 50% of people receiving ENHERTU or Kadcyla were still alive, the results could not be reported in months.

||Overall survival rate is the percentage of people who are still alive at a certain time point after either the date of diagnosis or the start of treatment.

Not tested for statistical significance and not designed to show differences between treatments. Statistical significance describes a mathematical measure of difference between groups. The difference is statistically significant if it is greater than what might be expected to happen by chance alone.

Response to treatment

Initial results (May 2021)

83% of people had their tumors shrink with ENHERTU and 36% with Kadcyla#**††

#This is called the overall response rate.

  • 16% (39 of 248 people) achieved a complete response with ENHERTU and 8% (20 of 241 people) with Kadcyla. A complete response means the tumor could not be seen on imaging tests
  • 67% (166 of 248 people) achieved a partial response with ENHERTU and 28% (67 of 241 people) with Kadcyla. A partial response means the tumor shrank by at least 30%
  • 15% (37 of 248 people) achieved stable disease with ENHERTU and 40% (97 of 241 people) with Kadcyla. This means that people did not have their tumor increase in size by more than 20% or decrease in size by more than 30%

Updated results (July 2022)

Overall response rates with ENHERTU and Kadcyla**‡‡

of people had
their tumors shrink
with ENHERTU

and

of people had
their tumors shrink
with Kadcyla

Of the people who responded to ENHERTU in the updated assessment:

  • 21% (52 of 246 people) achieved a complete response with ENHERTU and 9% (21 of 240 people) treated with Kadcyla
  • 61% (150 of 246 people) achieved a partial response with ENHERTU and 28% (67 of 240 people) treated with Kadcyla
  • 15% (38 of 246 people) achieved stable disease with ENHERTU and 40% (96 of 240 people) treated with Kadcyla

**Not statistically significant. Statistical significance describes a mathematical measure of difference between groups. The difference is statistically significant if it is greater than what might be expected to happen by chance alone.

††Based on the people in the first assessment with measurable disease (248 people who received ENHERTU and 241 people who received Kadcyla). In the first assessment, 205 (82.7%) of 248 people had their tumors shrink with ENHERTU and 87 (36.1%) of 241 people with Kadcyla.

‡‡Based on the people in the updated assessment with measurable disease (246 people who received ENHERTU and 240 people who received Kadcyla); 202 (82.1%) of 246 people had their tumors shrink with ENHERTU and 88 (36.7%) of 240 people with Kadcyla.

Disease control

Initial results (May 2021)

  • In the first assessment, 98% (242 of 248 people) treated with ENHERTU had their tumors either shrink, stop growing, or slow down

Updated results (July 2022)

98% of people treated with ENHERTU had their tumors respond to treatment in at least one of the following ways§§|| ||:

Shrink

Stop growing

Slow down

§§This is called the disease control rate.¶¶

A variety of patients with HER2+ mBC responded to ENHERTU.

|| ||In the updated assessment, 240 (97.6%) of 246 people treated with ENHERTU achieved disease control: 21.1% complete response (52 people) + 61.0% partial response (150 people) + 15.4% stable disease (38 people).

¶¶The disease control rate is the percentage of people who have achieved complete response, partial response, or stable disease.

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HER2, human epidermal growth factor receptor 2; HR, hormone receptor; mBC, metastatic breast cancer.

Photo of woman in confident pose: With ENHERTU® (fam-trastuzumab deruxtecan-nxki), I stand determined. Photo of woman in confident pose: With ENHERTU® (fam-trastuzumab deruxtecan-nxki), I stand determined. Photo of woman in confident pose: With ENHERTU® (fam-trastuzumab deruxtecan-nxki), I stand determined.
Not an actual patient.