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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

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%
*The amount of people who had their tumors shrink is called the objective response rate (or ORR).
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||

||97% is the disease control rate for the clinical study, which is the sum of the ORR and stable disease. In the study, 179 of 184 patients achieved a disease control rate. Stable disease means that the tumor did not increase in size by more than 20% nor decrease in size by more than 30%.
Calendar icon: 50% of people that responded maintained their response for 14.8 months

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.

||14.8 months is the median length of time people maintained their response to ENHERTU. This is called the duration of response.
Median is the middle number in a group of numbers arranged from lowest to highest.

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-
#ENHERTU helped shrink tumors in 56 of 97 people who were HR positive and 55 of 83 people who were HR negative. There were 4 people in the clinical study whose HR status
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
**14 of the 24 people saw their non-brain tumors shrink.

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:

  • Nausea
  • Feeling tired
  • Vomiting
  • Hair loss
  • Constipation
  • Decreased appetite
  • Low red blood cell counts
  • Low white blood cell counts
  • Diarrhea
  • Cough
  • 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.

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

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

What is the most important information I should know about ENHERTU?
ENHERTU can cause serious side effects, including:
Lung problems that may be severe, life-threatening or that may lead to death.
If you develop lung problems your healthcare provider may treat you with corticosteroid medicines. Tell your healthcare provider right away if you get any of the following signs and symptoms:

  • Cough
  • Trouble breathing or shortness of breath
  • Fever
  • Other new or worsening breathing symptoms (e.g., chest tightness, wheezing)

Low white blood cell count (neutropenia). Low white blood cell counts are common with ENHERTU and can sometimes be severe. Your healthcare provider will check your white blood cell counts before starting ENHERTU and before starting each dose. Tell your healthcare provider right away if you develop any signs or symptoms of an infection or have fever or chills during treatment with ENHERTU.

Heart problems that may affect your heart’s ability to pump blood. Your healthcare provider will check your heart function before starting treatment with ENHERTU. Tell your healthcare provider right away if you get any of the following signs and symptoms:

  • New or worsening shortness of breath
  • Coughing
  • Feeling tired
  • Swelling of your ankles or legs
  • Irregular heartbeat
  • Sudden weight gain
  • Dizziness or feeling light-headed
  • Loss of consciousness

Your healthcare provider will check you for these side effects during your treatment with ENHERTU. Your healthcare provider may reduce your dose, delay treatment or completely stop treatment with ENHERTU if you have severe side effects.

Harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with ENHERTU.

  • If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with ENHERTU.
  • Females who are able to become pregnant should use effective birth control (contraception) during treatment with ENHERTU and for at least 7 months after the last dose.
  • Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with ENHERTU and for at least 4 months after the last dose.

Before you receive ENHERTU, tell your healthcare provider about all of your medical conditions, including if you:

  • Have lung or breathing problems.
  • Have signs or symptoms of an infection.
  • Have or have had any heart problems.
  • Are breastfeeding or plan to breastfeed. It is not known if ENHERTU passes into your breast milk. Do not breastfeed during treatment with ENHERTU and for 7 months after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive ENHERTU?

  • You will receive ENHERTU into your vein through an intravenous (IV) line by your healthcare provider.
  • ENHERTU is given 1 time every three weeks (21-day treatment cycle).
  • Your healthcare provider will decide how many treatments you need.
  • Your healthcare provider may slow down or temporarily stop your infusion of ENHERTU if you have an infusion-related reaction, or permanently stop ENHERTU if you have severe infusion reactions.
  • 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.

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:

  • Nausea
  • Feeling tired
  • Vomiting
  • Hair loss
  • Constipation
  • Decreased appetite
  • Low red blood cell counts
  • Low white blood cell counts
  • Diarrhea
  • Cough
  • 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.

What is ENHERTU?

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 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.

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

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

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