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  5. Drug Trials Snapshots: IMJUDO
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Drug Trials Snapshots: IMJUDO

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the IMJUDO Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

IMJUDO (tremelimimab-actl)
im-JEW-doh
AstraZeneca UK LLC.
Original Approval date: October 21, 2022

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma.

How is this drug used?

IMJUDO is given as an intravenous infusion and given as a single dose in combination with durvalumab.

Who participated in the clinical trials?

The FDA approved IMJUDO plus durvalumab based on evidence from one clinical trial (HIMALAYA trial, NCT03298451) that enrolled 782 patients with unresectable liver cancer. The trial was conducted at 175 clinical centers in 16 countries across regions of North and South America, Eastern and Western Europe, and Asia.

How were the trials designed?

The trial enrolled patients with a type of liver cancer that cannot be removed by surgery (unresectable hepatocellular carcinoma) whose cancer was not previously treated with prescription medicine. The enrolled patients received either IMJUDO as one dose combined with durvalumab or received sorafenib until disease progressed or intolerable side effects. The benefit of IMJUDO plus durvalumab was measured by overall survival.

DEMOGRAPHICS SNAPSHOT

Figure 1. Baseline Demographics by Sex (Efficacy Population)

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 664 (85%) male patients and 118 (15%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2. Baseline Demographics by Race (Efficacy Population)

Pie chart summarizing how many White, Black or African American, Asian, and other patients were in the clinical trial. In total, 361 (46%) White patients, 17 (2%) Black or African American patients, 384 (49%) Asian patients, and 20 (3%) Other patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3 summarizes how many patients by age were enrolled in the clinical trial used to evaluate the efficacy of IMJUDO.

Figure 3. Baseline Demographics by Age (Efficacy Population)

Pie chart summarizing how many patients by age were in the clinical trial. In total, 390 (50%) patients younger than 65 years of age and 392 (50%) patients 65 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review
Efficacy population includes patients treated with IMJUDO + durvalumab and patients treated with sorafenib on the HIMALAYA trial

Figure 4. Baseline Demographics by Ethnicity (Efficacy Population)

Pie chart summarizing how many Hispanic, Not Hispanic, and other patients were in the clinical trial. In total, 42 (5%) Hispanic or Latino patients, 734 (94%) Not Hispanic or Latino patients, and 6 (1%) patients with missing ethnicity data participated in the clinical trial.

Source: Adapted from FDA Review
Efficacy population includes patients treated with IMJUDO + durvalumab and patients treated with sorafenib on the HIMALAYA trial

What are the benefits of this drug?

In the trial, IMJUDO plus durvalumab lowered the risk of death by 22%, and 20% of people saw their tumor partially or fully shrink.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: IMJUDO plus durvalumab worked similarly in males and females.
  • Race: The majority of patients were Asian or White. IMJUDO plus durvalumab worked similarly in these populations. Due to the small number of patients in other racial subgroups, differences in response among racial groups could not be determined.
  • Age: IMJUDO plus durvalumab worked similarly in patients younger and older than 65 years of age

What are the possible side effects?

The most common side effects (≥20%) in patients treated with IMJUDO are rash, diarrhea (loose stools) or more frequent bowel movements than usual, extreme tiredness, itching of the skin, muscle pain, and abdominal pain.

IMJUDO may cause serious side effects including inflammation of the lung (pneumonitis), inflammation of the liver (hepatitis), inflammation of the intestines (colitis), hormone glands injury (pituitary, thyroid, adrenal, pancreas), inflammation of the kidney (nephritis), and may harm an unborn baby.

Were there any differences in side effects of the clinical trials among sex, race, and age?

  • Sex: The occurrence of side effects was similar in males and females. The occurrence of more serious side effects (grade ≥3) in patients treated with IMJUDO plus durvalumab was higher in females.
  • Race: Most patients were Asian or White, the occurrence of side effects was similar across these racial groups. The occurrence of more serious side effects (grade ≥3) in patients treated with IMJUDO plus durvalumab was higher in White than Asian patients. Due to the small number of patients in other racial groups, differences in side effects among races could not be determined.
  • Age: The occurrence of side effects was similar in patients younger and older than 65 years of age. The occurrence of more serious side effects (grade ≥3) in patients treated with IMJUDO plus durvalumab was higher in patients older than 65 years of age.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

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