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  5. Drug Trials Snapshot: MARGENZA
  1. Drug Approvals and Databases

Drug Trials Snapshot: MARGENZA

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age 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 health provider about the risks and benefits of a drug. Refer to the MARGENZA Package Insert for complete information.

MARGENZA (margetuximab-cmkb)
(mar-GEN-zuh)
MacroGenics
Approval date: December 16, 2020


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

MARGENZA is a drug for treatment of metastatic HER2-positive breast cancer in adult patients who have been previously treated for their metastatic disease.

How is this drug used?

MARGENZA is an injection. It is given by a healthcare provider directly into the vein (intravenous infusion) every three weeks in combination with chemotherapy.

What are the benefits of this drug?

Patients who received MARGENZA in combination with chemotherapy lived longer without cancer progression in comparison to patients who received an approved drug trastuzumab in combination with chemotherapy.

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

  • Sex: Almost all patients in the trial were women; therefore, sex differences in how well the drug worked could not be determined.
  • Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in how well the drug worked among races could not be determined.
  • Age: MARGENZA worked similarly in patients above and below 60 years of age.

What are the possible side effects?

MARGENZA may cause serious side effects, including weakening of the heart, a harm to unborn baby and infusion reactions.

The most common side effects include fatigue, nausea, diarrhea, and vomiting.

Were there any differences in side effects among sex, race and age?

  • Sex: Almost all patients in the trial were women; therefore, differences in side effects between men and women could not be determined.
  • Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in side effects among races could not be determined.
  • Age: The occurrence of overall side effects was similar in patients younger than 65 years and those 65 years and older. More severe side effects (grade 3-4) were seen more frequently in patients above 65 years. Also, heart toxicity side effects were seen more commonly in patients 65 years and older.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved MARGENZA based primarily on evidence from one clinical trial (NCT02492711) of 536 patients 27 to 86 years old with HER2-positive, metastatic breast cancer who had been previously treated for their metastatic disease. The trial was conducted at 166 sites in the United States and 16 other countries.

Figure 1 summarizes how many women were in the clinical trial.

Figure 1. Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trials. In total, 3 men (1%) and 533 women (99%) participated in the clinical trial.

FDA Review

Figure 2 summarizes patients by race in the clinical trial.

Figure 2. Demographics by Race

Pie chart summarizing how many patients of different races were in the clinical trial.  In total, 427 patients were White (80%), 34 patients were Asian (6%), 28 patients were Black or African American (5%), and 47 patients were Other (9%).

FDA Review

Figure 3 summarizes patients by age in the clinical trial.

Figure 3. Demographics by Age

Pie chart summarizing how many individuals of certain age groups were in the clinical trial.  In total, 421 patients were less than 65 years old (79%), 91 patients were between 65-74 years old (17%) and 24 patients were 75 years and older (4%).

FDA Review

Figure 4 summarizes patients by ethnicity in the clinical trial.

Figure 4. Demographics by Ethnicity

Pie chart summarizing how many individuals of certain ethnicity groups were in the clinical trial.  In total, 46 patients were Hispanic or Latino (9%), 431 patients were not Hispanic or Latino (80%), and for 59 patients ethnicity was not reported (11%).

FDA Review

How were the trials designed?

MARGENZA was studied in one trial that enrolled patients with HER2-positive, metastatic breast cancer who have been treated for their metastaic disease before.

The trial compared patients who were randomly assigned to receive either MARGENZA or trastuzumab infusions every three weeks in addition to chemotherapy. Both, the patients and the health care providers knew which treatment was being given. The treatment continued until the disease progression or the side effects became too toxic.

The trial compared the length of time patients were alive without cancer progression between the two groups.

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 used in clinical trials 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.

PRESCRIBING INFORMATION

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