How was ENHERTU studied?
ENHERTU is a prescription medicine used in adults to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received two or more prior anti-HER2 breast cancer treatments.
ENHERTU was studied in 184 people with HER2+ unresectable or metastatic breast cancer who had already received at least 2 other prior treatments for HER2+ breast cancer.
What were the results of the ENHERTU study?
The majority of people had their tumors shrink with ENHERTU
In a clinical study of 184 women, most people treated with ENHERTU (60%) saw their tumors shrink*†
- Some people (4.3%‡) achieved what is known as a complete response, meaning their tumor could not be seen on imaging tests
- Most people (56%§) achieved a partial response, which means the tumor shrank by at least 30%
†111 of 184 people saw their tumors shrink.
‡8 of 184 people achieved a complete response.
§103 of 184 people achieved a partial response.
97% of people treated with ENHERTU had their tumors shrink, stop growing, or the growth of their tumors slowed||
Half of the people who responded to ENHERTU maintained their response for nearly 15 months
In the same clinical study, half of the 111 people who responded to ENHERTU were able to maintain their response for 14.8 months or longer.tt However, how long responses lasted varied by person.
Median is the middle number in a group of numbers arranged from lowest to highest.
Half of the people who received ENHERTU lived without their cancer growing or spreading for more than
Half of the people who received ENHERTU lived without their cancer growing or spreading for more than 16 months
Progression-free survival is another result that was evaluated in this clinical study of 184 people.
Half of the 184 people who received ENHERTU lived without their cancer growing or spreading for more than 16.4 months. The median progression-free survival (also referred to as median PFS) is the length of time from the start of treatment that half of the people in the study had gone without disease progression.
For ENHERTU, the median progression-free survival was 16.4 months. The median reflects the middle number within a group of numbers arranged from lowest to highest.
This study only evaluated ENHERTU. There was no comparison of results to another treatment option for HER2+ metastatic breast cancer.
Patients are examined and evaluated throughout a clinical study. The median length of time that half the patients in this clinical study received follow-up evaluation was 11.1 months. The length of time that each patient was studied varied. The last date the patients in this study were evaluated was August 1, 2019.
ENHERTU was FDA approved based on the clinical study results that showed how many people responded and how long they responded. The FDA has not reviewed the progression-free survival data. ENHERTU is still being studied to confirm these results.
A variety of patients with HER2+ mBC responded to ENHERTU
ENHERTU was evaluated in 180 people from the study who were either hormone receptor positive (HR+) or hormone receptor negative (HR-)#
ENHERTU helped shrink tumors in:
- 58% of people who were HR+
- 66% of people who were HR-
was not known.
In the same clinical study of 184 people, ENHERTU was explored in 24 people with HER2+ mBC that had spread to the brain and was stable
- 58% of these 24 people had their non-brain tumors shrink**
- Presence of brain metastases was noted but was not measured
What are the possible side effects of ENHERTU?
ENHERTU can cause serious side effects. See "What is the most important information I should know about ENHERTU?"
The most common side effects of ENHERTU include:
- Feeling tired
- Hair loss
- Decreased appetite
- Low red blood cell counts
- Low white blood cell counts
- Low platelet counts
ENHERTU may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.
These are not all of the possible side effects of ENHERTU. Call your doctor for medical advice about side effects. You may report side effects to Daiichi Sankyo at 1-877-437-7763 or to FDA at 1-800-FDA-1088.
Should ENHERTU be a part for
your treatment journey?
team about ENHERTU
HER2, human epidermal growth factor 2; HR+, hormone-receptor positive; HR-, hormone-receptor negative; mBC, metastatic breast cancer.