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What is ENHERTU?
ENHERTU is a prescription medicine used to treat adults who have HER2-low breast cancer that cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received a prior chemotherapy for metastatic disease, or your disease has returned during or within 6 months of completing adjuvant chemotherapy (after surgery). Your healthcare provider will perform a test to make sure ENHERTU is right for you.
How was ENHERTU studied in HER2-low mBC?
ENHERTU was studied in many types of adults, including those with different:
- Ages
- HR status
- Levels of HER2
- Number of previous treatments
ENHERTU was compared to chemotherapy in a clinical study of 557 adults (373 treated with ENHERTU and 184 treated with chemotherapy) who:
- Had low levels of HER2 proteins
- Had either HR+ (494 people) or HR– (63 people) unresectable or metastatic breast cancer (mBC)
- Had already received chemotherapy for metastatic disease, or had the disease return during or within 6 months of completing adjuvant chemotherapy (after surgery)
- If HR+, had received at least one hormonal therapy or was ineligible for hormonal therapy
What were the results of the ENHERTU study?
Progression-free survival
ENHERTU nearly DOUBLED THE TIME people lived without their cancer growing or spreading compared to chemotherapy*†
In people who had either HR+ or HR– HER2-low mBC
with ENHERTU
VS
with chemotherapy
with chemotherapy
This is called median progression-free survival.
A median is the middle number in a set of numbers.‡
*At the time of follow-up, 130 (34.9%) of 373 people treated with ENHERTU lived without their cancer progressing or them dying; 57 (31.0%) of 184 people treated with chemotherapy lived without their cancer progressing or them dying.
†Patients received physician’s choice of chemotherapy. Out of 184 patients, 94 received eribulin, 37 received capecitabine, 19 received gemcitabine, 19 received nab-paclitaxel, and 15 received paclitaxel.
‡Median progression-free survival is the midpoint between people who lived the longest without their cancer progressing or them dying and those who lived for the shortest period of time without their cancer progressing or them dying.
- 331 people who were HR+ and who were treated with ENHERTU lived a median of 10.1 months without their cancer growing or spreading compared to; 5.4 months for 163 people who were treated with chemotherapy
- The small group of 40 people included in this study who were HR– and treated with ENHERTU lived a median of 8.5 months without their cancer growing or spreading; 2.9 months for 18 people who were treated with chemotherapy§
- - Before the approval of ENHERTU for HER2-low (IHC 1+ or IHC 2+/ISH–) mBC, these people might have been told by their healthcare providers that they had triple-negative breast cancer (HR– and HER2-negative)
§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.
Overall survival
People treated with ENHERTU were alive a median of 23.4 months vs 16.8 months for those who received chemotherapy†||
In people who had either HR+ or HR– HER2-low mBC
with ENHERTU
VS
with chemotherapy
with chemotherapy
This is called median overall survival.¶ A median is the middle number in a set of numbers.
†Patients received physician’s choice of chemotherapy. Out of 184 patients, 94 received eribulin, 37 received capecitabine, 19 received gemcitabine, 19 received nab-paclitaxel, and 15 received paclitaxel.
||At the time of follow-up, 224 (60.1%) of 373 people treated with ENHERTU were alive; 94 (51.1%) of 184 people treated with chemotherapy were alive; median follow-up was 18.4 months.
¶Median overall survival is the length of time, from either the date of diagnosis or the start of treatment, that half the patients in a group are still alive.
Response to treatment
52% of people had their tumors shrink with ENHERTU (16% with chemotherapy)†#
In people who had either HR+ or HR– HER2-low mBC
More than 5 out of 10 people
responded to ENHERTU
About 1.5 out of 10 people
responded to chemotherapy
This is called overall response rate.**
Of the people who responded to ENHERTU:
- 4% of people treated with ENHERTU and 1% of people treated with chemotherapy achieved a complete response. A complete
response means the tumor could not be seen on imaging tests†† - 49% of people treated with ENHERTU and 15% treated with chemotherapy achieved a partial response. A partial response means there was at least 30% tumor shrinkage‡‡
- 35% of people treated with ENHERTU and 50% treated with chemotherapy achieved stable disease. This means their tumor did not increase in size 20% or more, nor decrease in size 30% or more§§
#195 (52.3%) of 373 people treated with ENHERTU and 30 (16.3%) of 184 people treated with chemotherapy had their tumors shrink or stop growing.
**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.
††13 (3.5%) of 373 people treated with ENHERTU and 2 (1.1%) of 184 people treated with chemotherapy achieved a complete response.
‡‡183 (49.1%) of 373 people treated with ENHERTU and 28 (15.2%) of 184 people treated with chemotherapy achieved a partial response.
§§129 (34.6%) of 373 people treated with ENHERTU and 91 (49.5%) of 184 people treated with chemotherapy achieved stable disease.
Disease control
Nearly 90% 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 disease control rate.|| ||
|| ||The disease control rate is the percentage of patients who have achieved complete response, partial response, or stable disease. 325 (87.1%) of 373 people treated with ENHERTU achieved disease control.
HER2, human epidermal growth factor receptor 2; HR+, hormone receptor-positive; HR–, hormone receptor-negative; IHC, immunohistochemistry; ISH, in-situ hybridization.
