A new DRUG TRIALS SNAPSHOT is now available
Drug Trial Snapshot: LIBTAYO
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.
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 LIBTAYO Prescribing Information for complete information.
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 LIBTAYO Prescribing Information for complete information.
LIBTAYO (cemiplimab-rwlc)
Lib-TIE-oh
Regeneron
Approval date:September 28, 2018
Lib-TIE-oh
Regeneron
Approval date:September 28, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
LIBTAYO is a drug for the treatment of one type of skin cancer called cutaneous squamous cell carcinoma(CSCC). It is approved to treat patients whose cancer has spread through the body (metastatic) or is locally advanced and who cannot have radiation or surgery to remove all the cancer.
How is this drug used?
LIBTAYO is an injection. It is given by a healthcare professional directly into the vein (an intravenous infusion) over 30 minutes every 3 weeks.
What are the benefits of this drug?
LIBTAYO treatment led to tumor shrinkage or tumor disappearance in 47% of treated patients.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: LIBTAYO works similarly in men and women.
- Race: Most patients in the trials were White. Differences in how well LIBTAYO works among races could not be determined.
- Age: LIBTAYO works similarly in patients younger and older than 65 years of age.
What are the possible side effects?
LIBTAYO can cause serious and potentially deadly immune reactions including inflammation of the lungs, gut, liver, kidneys, hormonal glands and skin as well as infusion related reactions.
The most common adverse reactions are fatigue, rash and diarrhea.
Were there any differences in side effects among sex, race and age?
- Sex: Occurrence of side effects was similar in men and women.
- Race: Most of the patients in the trials were White. Differences in side effects among races could not be determined.
- Age: Occurrence of side effects was similar in patients younger and older than 65 years of age.
WHO WAS IN THE STUDIES?
Who participated in the clinical trials?
The FDA approved LIBTAYO based on evidence from two clinical trials (Trial 1/ NCT02383212, and Trial 2/NCT02760498) that enrolled 163 patients with advanced cutaneous squamous cell carcinoma(CSCC). The trials were conducted in United States, Australia and Europe.
Demographics of patients who were assessed for the benefit of LIBTAYO (efficacy population) is presented in Table 8 under MORE INFO.
The figure below summarizes how many men and women in both trials combined received at least one dose of LIBTAYO and provided data for evaluation of side effects (safety population).
Figure 1. Baseline Demographics by Sex (safety population)
Clinical Trial Data
The figure and table below summarize the percentage of patients by race in safety population.
Figure 2. Baseline Demographics by Race (safety population)
Clinical Trial Data
Table 1. Baseline Demographics by Race (safety population)
Race
|
Number of Patients
|
Percentage of Patients
|
|---|---|---|
White
|
157
|
96
|
Black or African American
|
1
|
1
|
Asian
|
2
|
1
|
Unknown/not reported
|
3
|
2
|
Clinical Trial Data
The figure below summarizes the percentage of patients by age in safety population.
Figure 3. Baseline Demographics by Age (safety population)
Clinical Trial Data
How were the trials designed?
The FDA approved LIBTAYO based on evidence from two clinical trials that enrolled patients with advanced cutaneous squamous cell carcinoma(CSCC). Both trials included patients with metatatic cancer and with locally advanced cancer.
All patients received LIBTAYO intravenously every 2 weeks for up to 48 weeks in Trial 1 or up to 96 weeks in Trial 2. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment.
The trial measured the proportion of patients who experienced partial shrinkage or complete disappearance of their tumors while receiving LIBTAYO.
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.
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.
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