Why KIMMTRAK?

KIMMTRAK clinical trial results (primary)

KIMMTRAK was studied in a large phase 3 clinical trial in adults with metastatic uveal melanoma (mUM) who were HLA-A*02:01 positive and had not received previous treatment for their cancer

378 adults with mUM who were HLA-A*02:01 positive participated.
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Primary analysis:
  • The average time that someone who received KIMMTRAK® (tebentafusp-tebn) lived was 21.7 months compared to 16.0 months with other treatments studied, including:

On average, patients had 14.1 months of follow-up.

These results were statistically significant.

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KIMMTRAK clinical trial results (3-YEAR follow-up)

After the primary analysis, patients continued to follow the clinical trial procedures

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In a follow-up analysis of the clinical trial:
  • The average time that someone who received KIMMTRAK lived was 21.6 months compared to 16.9 months with other treatments studied, including:
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All patients included in these results had at least 36 months of follow-up, and on average, they had 43.3 months of follow-up.

These data were not tested for statistical significance. KIMMTRAK may not work for everyone. Individual results may vary.

What side effects have been seen with KIMMTRAK?

The most common side effects of KIMMTRAK include:
  • Cytokine release syndrome (CRS)
  • Rash
  • Fever
  • Itching
  • Tiredness
  • Nausea
  • Chills
  • Stomach pain
  • Swelling
  • Low blood pressure (symptoms may include dizziness or light-headedness)
  • Dry skin
  • Headache
  • Vomiting
  • Abnormal liver blood tests
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Side effects related to KIMMTRAK were generally predictable (expected to occur) and were managed with certain medications
  • In the clinical trial, side effects usually happened during the first few doses.
  • In the clinical trial primary analysis, 3.3% (8 out of 245) of patients stopped taking KIMMTRAK due to treatment-related side effects.
  • In the 3-YEAR follow-up analysis, no new safety issues were observed and side effects were similar to those previously seen in the primary analysis.

Pay attention to how you are feeling, and
talk to your doctor if you have questions.cta icon

Possible side effects

Some side effects may occur as a reaction from your immune system responding to treatment. Knowing what side effects to expect and when they are most likely to occur can help you prepare.

Cytokine release syndrome (CRS)
  • 89% of patients experienced some symptoms of CRS. 84% of the time, CRS started the day of the infusion.
  • 1.2% discontinued their treatment as a result.
  • Symptoms of CRS may include fever, tiredness or weakness, vomiting, chills, nausea, low blood pressure, dizziness and light-headedness, headache, wheezing and trouble breathing, and rash.
  • Fever is usually the first sign of CRS, so let your healthcare team know if you are feeling feverish. They will want to track your symptoms closely so they can manage them.
  • In the clinical trial, CRS usually decreased and was less severe after the first few doses.

CRS is a side effect that may happen with KIMMTRAK because the treatment works by activating your immune system.

Rash
  • Rash occurred in 83% of patients.
    • None discontinued their treatment as a result.
  • A red rash can appear on all or part of the body, and it may peel or feel itchy and painful. It may appear similar to a sunburn but can look and feel differently for each individual.
  • In the clinical trial, most rashes got better or went away with time.

Metastatic uveal melanoma cells are similar to your skin cells. In an effort to fight your cancer, KIMMTRAK may also affect some of your skin cells, resulting in a rash.

Abnormal liver blood tests
  • 65% of patients had elevated liver enzymes.
    • 0.4% discontinued their treatment as a result.
  • Symptoms may include right-sided abdominal pain or yellowing of the skin or eyes.
  • Your doctor will do blood tests to check your liver before you start KIMMTRAK and during treatment with KIMMTRAK.

NOTE: These are not all the possible side effects of KIMMTRAK. Call your doctor for medical advice about side effects.

How often certain side effects* happened each week
during treatment with KIMMTRAK
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  • * Treatment-related side effects.
  • CRS was identified by using the American Society for Transplant and Cellular therapy (ASTCT) criteria.
  • Rash includes a variety of skin-related side effects.
  • This chart was published in the New England Journal of Medicine in 2021. © 2021 Massachusetts Medical Society. It has been adapted with permission from Massachusetts Medical Society.
  • N = Number of patients taking KIMMTRAK.

What should I do if I develop a side effect when I go home after my infusion?

After you’ve completed your post-infusion observation time and have gone home, you may develop side effects.

The first few weeks may be the most challenging as your immune system begins to work with KIMMTRAK. In the clinical trial, most patients remained on treatment.

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Contact your doctor right away if you develop any of the symptoms listed.
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Considering KIMMTRAK

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How to talk to your doctor about KIMMTRAK

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Questions for your doctor

Consider discussing the following questions with your doctor to help determine if KIMMTRAK may be the right treatment for you:

Thinking about KIMMTRAK?

  • Am I a candidate for KIMMTRAK?
  • Could KIMMTRAK help me live longer?
  • What are the possible side effects and safety considerations of KIMMTRAK?
  • How soon can I start KIMMTRAK?

Where will I go to receive KIMMTRAK?

  • Which healthcare professionals will oversee my treatment?
  • Who do I contact with questions and/or concerns?
  • What can I expect at the treatment center?
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You and your doctor will work together to determine if treatment with KIMMTRAK will help you meet your treatment goals.
KIMMTRAK is given as a weekly intravenous (IV) infusion.
Up next: Taking KIMMTRAK
Indication
 
Important Safety Information Including Boxed Warning

KIMMTRAK is a prescription medicine used to treat HLA-A*02:01–positive adults with uveal melanoma that cannot be removed by surgery or has spread.

KIMMTRAK can cause serious side effects that can be severe or life threatening and usually happen within the first three infusions, including:

  • Cytokine Release Syndrome (CRS). Symptoms of CRS may include:

Indication and Important Safety Information Including Boxed Warning

Usage

KIMMTRAK is a prescription medicine used to treat HLA-A*02:01–positive adults with uveal melanoma that cannot be removed by surgery or has spread.

Important Safety Information

What is the most important information I should know about KIMMTRAK?

KIMMTRAK can cause serious side effects that can be severe or life threatening and usually happen within the first three infusions, including:

  • Cytokine Release Syndrome (CRS). Symptoms of CRS may include:
    • fever
    • tiredness or weakness
    • vomiting
    • chills
    • nausea
    • low blood pressure
    • dizziness and light-headedness
    • headache
    • wheezing and trouble breathing
    • rash

Tell your healthcare provider right away if you get any of these symptoms. Your healthcare provider will check for these problems during treatment with KIMMTRAK. Your healthcare provider may temporarily stop or completely stop your treatment with KIMMTRAK if you have severe side effects.

See "KIMMTRAK can cause other serious side effects" for more information.

Before receiving KIMMTRAK, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. KIMMTRAK may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with KIMMTRAK.

    For females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with KIMMTRAK.
    • Use an effective form of birth control during treatment with KIMMTRAK and for at least 1 week after the last dose of KIMMTRAK.
  • are breastfeeding or plan to breastfeed. It is not known if KIMMTRAK passes into your breast milk. Do not breastfeed during the treatment with KIMMTRAK and for at least 1 week after the last dose of KIMMTRAK.

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

KIMMTRAK can cause other serious side effects, including:

  • Skin reactions. KIMMTRAK may cause skin reactions that require treatment. Tell your healthcare provider if you get symptoms of skin reactions—such as rash, itching, or skin swelling—that are severe and do not go away.
  • Abnormal liver blood tests. Your healthcare provider will do blood tests to check your liver before you start KIMMTRAK and during treatment with KIMMTRAK. Tell your healthcare provider if you get symptoms of liver problems such as right-sided abdominal pain or yellowing of the skin or eyes.

The most common side effects of KIMMTRAK include:

  • cytokine release syndrome (CRS)
  • rash
  • fever
  • itching
  • tiredness
  • nausea
  • chills
  • stomach pain
  • swelling
  • low blood pressure (symptoms may include dizziness or light-headedness)
  • dry skin
  • headache
  • vomiting
  • abnormal liver blood tests

These are not all the side effects possible with KIMMTRAK.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).

Please read the accompanying Patient Information Leaflet before you receive KIMMTRAK and discuss any questions you have with your healthcare provider.

Please see KIMMTRAK Patient Information.

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