Understanding the Results

How was ENHERTU
studied?

ENHERTU was studied in a clinical trial of 101 adults who received a 5.4 mg/kg dose and:

Had HER2-mutant NSCLC that had spread to other parts of their body (metastatic) or could not be removed by surgery (unresectable)
Had their disease return after a prior treatment for lung cancer

The study included many types of adults, including those of different ages, races, genders, and smoking histories.

This study only evaluated ENHERTU. There was not a comparison of results to another treatment option for HER2-mutant metastatic NSCLC.

What were the results of the ENHERTU study?

Overall response rate

In a clinical study, about 58% of people treated with ENHERTU had their tumors shrink

~56% (29 of 52)

of people achieved what is known as a partial response, meaning their tumor shrank by at least 30%

~2% (1 of 52)

of people achieved what is known as a complete response, meaning their tumor could not be seen on imaging tests

This is called overall response rate. Overall response rate is the proportion of patients who have a partial or complete response to therapy.

Median duration of response

Half of the people who responded to ENHERTU were still responding after nearly 9 months

9months

This is called median duration
of response.*

ENHERTU is still being studied to confirm these results.

^*A median is the middle number in a set of numbers. Median duration of response is the length of time half of the people in the trial continued to respond after the first response was seen.

ENHERTU was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. ENHERTU is still being studied to confirm these results.

Not an actual patient.

HER2 mutations can occur in a range of people with NSCLC, and the cause of these mutations is unknown

Response to ENHERTU was studied in adults with HER2-mutant unresectable or metastatic NSCLC, including those of different ages, genders, races, smoking histories, and prior treatments.

ENHERTU is also approved for other uses beyond HER2-mutant NSCLC, including metastatic solid tumors with HER2 overexpression (IHC 3+).

A healthcare provider will determine eligibility for ENHERTU based on HER2 mutation via NGS testing or HER2 overexpression via IHC testing. Further details about the benefits and risks of ENHERTU, including other approved uses are available on this website.

Starting treatment with ENHERTU? Learn more about ENHERTU, including Important Safety Information

Download patient brochure

HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; NGS, next-generation sequencing; NSCLC, non-small cell lung cancer.