UNDERSTANDING THE SCIENCE

What is HER2+ advanced stomach cancer?

Number One

What is HER2? HER2 is a protein that tells cells to grow. In HER2+ stomach cancer, the cancer cells have too much HER2, which leads to cancer growth

Number Two

These cells grow
and divide faster
than healthy cells, causing tumors to form

Number Three

In advanced
stomach cancer,
the cancer has started to spread to areas near the stomach or to other parts of the body

What is ENHERTU?

ENHERTU® (fam-trastuzumab deruxtecan-nxki) is a prescription medicine used in adults:

  • To treat HER2+ stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma that has spread to areas near your stomach (locally advanced) or that has spread to other parts of your body (metastatic), and
  • Who have received a prior trastuzumab-based regimen

It is not known if ENHERTU is safe and effective in children.

How was ENHERTU studied?

ENHERTU was studied in comparison with the doctor’s choice between 2 commonly used chemotherapies (irinotecan or paclitaxel) in 188 people with HER2+ advanced stomach cancer.

How is ENHERTU thought to work?

As a type of targeted treatment called an antibody-drug conjugate (ADC), ENHERTU is designed to work differently than traditional chemotherapies.

ENHERTU is made up of an antibody with a chemotherapy attached
The antibody part of ENHERTU targets and attaches to the HER2+ cancer cell
ENHERTU enters the cancer cell and the chemotherapy is released
The chemotherapy part of ENHERTU helps destroy the cancer cell as well as other cells nearby

Although ENHERTU is designed to target HER2+ cancer cells, it may affect healthy cells.
ENHERTU may not work for everyone.

How will I receive my ENHERTU treatment?

ENHERTU is taken alone without the need for other cancer medicines to treat advanced stomach cancer

ENHERTU is given as an intravenous (IV) infusion once every 3 weeks.

The first infusion will take about 90 minutes so the doctor can see if there are any side effects or problems

Future infusions should take about 30 minutes, if your first infusion was well tolerated

To help manage your side effects, your healthcare provider may:

Lower your dose

Delay your dose

Stop ENHERTU

Your healthcare provider will give you medicines before your infusion to help prevent nausea and vomiting.

To help manage your side effects, your healthcare provider may:

Lower
your dose

Delay
your dose

Stop
ENHERTU

Your healthcare provider will give you medicines before your infusion to help prevent nausea and vomiting.

Your healthcare provider will decide how many treatments you need

Your healthcare provider may obtain a new tumor sample before starting ENHERTU.

Your healthcare provider may adjust your dose if you have side effects with ENHERTU

  • Your healthcare provider may slow down or temporarily stop your infusion of ENHERTU if you have an infusion-related reaction
  • Your healthcare provider may permanently stop ENHERTU if you have certain side effects
  • If you miss a planned dose of ENHERTU, call your healthcare provider right away to schedule an appointment. Do not wait until the next planned treatment cycle

Your healthcare provider will give you medicines before your infusion to help prevent nausea and vomiting

Results with ENHERTU

In a clinical study of 188 people with previously treated HER2+ advanced stomach cancer,

ENHERTU helped people live longer than with chemotherapy*

Among people in the trial…

Half of the people taking chemotherapy were alive at 8.4 months

VS

Half of the people taking ENHERTU were alive at
12.5 months

About 4 months longer with ENHERTU

*Chemotherapy used in the clinical study was the doctor’s choice between 2 commonly used chemotherapies (irinotecan or paclitaxel).

63 of 126 people taking ENHERTU were still alive after 12.5 months vs 23 out of 62 people taking chemotherapy.

In the same clinical study,

Tumors shrank in more people treated with ENHERTU than with chemotherapy*‡

  • 40.5% (51 of 126) of people saw a confirmed response with ENHERTU vs 11.3% (7 of 62) did with chemotherapy‡§

About 4 out of 10 people responded to ENHERTU

VS

About 1 out of 10 people responded to chemotherapy

  • 7.9% (10 of 126) of people taking ENHERTU achieved a complete response, meaning their tumor could not be seen on imaging tests. This does not always mean the cancer has been cured. No one taking chemotherapy (0 of 62) had a complete response
  • 32.5% (41 of 126) of people taking ENHERTU achieved a partial response, which means the tumor shrank by at least 30%; 11.3% (7 of 62 people) of those taking chemotherapy had a partial response
  • 84% (106 of 126 people) of people taking ENHERTU saw their tumors shrink, stop growing, or the growth of their tumors slowed, and 61% (38 of 62) of people saw this while receiving chemotherapyll

*Chemotherapy used in the clinical trial was the doctor's choice between 2 commonly used chemotherapies (irinotecan or paclitaxel).

The number of people who had their tumors shrink is called the objective response rate (or ORR).

§The response was observed by the treating doctor and then agreed upon by a review panel. A second scan 4 or more weeks after the first was used to confirm the results.

||The 84% shown is the disease control rate, which is the sum of the ORR and stable disease rate. Stable disease means that the tumor did not increase in size by more than 20% nor decrease in size by more than 30%.

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, when used in people with stomach cancer, include:

  • Low red blood cell counts
  • Low white blood cell counts
  • Low platelet counts
  • Nausea
  • Decreased appetite
  • Increased liver function tests
  • Feeling tired
  • Diarrhea
  • Low levels of blood potassium
  • Vomiting
  • Constipation
  • Fever
  • Hair loss

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 FDA at 1-800-FDA-1088.

Please click here for full Prescribing Information, including Boxed WARNINGS, and click here for Medication Guide.

Downloadable Resources for Patients and Care Partners

Understanding and managing
side effects during treatment
with ENHERTU

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