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Drug Trials Snapshots: ZYNYZ

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 ZYNYZ Prescribing Information for all 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).

ZYNYZ (retifanlimab-dlwr)
ZYE-niz
Incyte Corporation
Approval date: March 22, 2023


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

ZYNYZ is used to treat a type of skin cancer called Merkel cell carcinoma (MCC) in adults. It is used in patients where the cancer has spread through the body (metastatic) or cannot be controlled with surgery and/or radiation.

How is this drug used?

ZYNYZ is given by a healthcare provider using a needle placed in a vein (known as intravenous infusion) over 30 minutes. ZYNYZ is given every four weeks.

Who participated in the clinical trials?

The FDA approved ZYNYZ based on evidence from one clinical trial of patients with metastatic or recurrent locally advanced MCC who had not received prior chemotherapy. A total of 65 patients were evaluated to see if the size of their tumor changed (efficacy population) and 105 patients were evaluated for side effects (safety population). The trial was conducted at 34 sites in Italy, France, the United States, Poland, Canada, Switzerland, Hungary, the Czech Republic, Germany, Spain, and the United Kingdom.

How were the trials designed?

The benefit and side effects of ZYNYZ were evaluated in one clinical trial of patients with metastatic or recurrent locally advanced MCC. The trial measured the percentage of patients who experienced partial shrinkage or complete disappearance of their tumor. All patients received ZYNYZ once every four weeks until either the tumors grew or the patients developed an unacceptable side effect.

The benefit of ZYNYZ was evaluated by the percentage of patients who achieved partial or complete shrinkage of their tumors (objective response rate or ORR) and by how long that shrinkage lasted (duration of response or DOR).


DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many male and female patients were enrolled in the clinical trial used to evaluate the efficacy of ZYNYZ.

Figure 1. Baseline Demographics by Sex, Efficacy Population

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 42 (65%) male patients and 23 (35%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes how many patients by sex were enrolled in the trial used to evaluate the side effects of ZYNYZ.

Figure 2. Baseline Demographics by Sex, Safety Population

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 42 (65%) male patients and 23 (35%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3 summarizes how many patients by race enrolled in the clinical trial used to evaluate the efficacy of ZYNYZ.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many White, Asian, and not reported patients were in the clinical trial. In total, 51 (78%) White patients, 1 (2%) Asian patient, and 13 (20%) not reported patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes how many patients by race were enrolled in the trial used to evaluate the side effects of ZYNYZ.

Figure 4. Baseline Demographics by Race, Safety Population

Pie chart summarizing how many White, Asian, and not reported patients were in the clinical trial. In total, 83 (79%) White patients, 1 (1%) Asian patient, and 21 (20%) not reported patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 5 summarizes how many patients by age were enrolled in the clinical trial used to evaluate the efficacy of ZYNYZ.

Figure 5. Baseline Demographics by Age, Efficacy Population

Pie chart summarizing how many patients by age were in the clinical trial. In total, 14 (22%) patients younger than 65 years of age and 51 (78%) patients 65 years of age and older participated in the clinical trial

Source: Adapted from FDA Review

Figure 6 summarizes how many patients by age were in the trial used to evaluate the side effects of ZYNYZ.

Figure 6. Baseline Demographics by Age, Safety Population

Pie chart summarizing how many patients by age were in the clinical trial. In total, 27 (26%) patients younger than 65 years of age and 78 (74%) patients 65 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 7 summarizes how many patients by ethnicity were enrolled in the trial used to evaluate the efficacy of ZYNYZ.

Figure 7. Baseline Demographics by Ethnicity, Efficacy Population

Pie chart summarizing how many not Hispanic and unknown patients were in the clinical trial. In total, 52 (80%) Not Hispanic or Latino patients and 13 (20%) unknown patients participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

In the trial PODIUM-201, 34 of 65 patients (52%) with MCC who were treated with ZYNYZ experienced a decrease in the size of their tumors (34%) or their tumors could no longer be detected (18%). Tumor shrinkage lasted more than 6 months for 76% of those patients and more than 12 months for 62% of patients.

ZYNYZ was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.

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

  • Sex: The observed effect of ZYNYZ was similar for females and males.
  • Race: The number of patients of races other than White was small; therefore, differences in how ZYNYZ worked among races could not be determined.
  • Age: The number of patients of <65 years was small; therefore, differences in how ZYNYZ worked among different age groups could not be determined.

What are the possible side effects?

ZYNYZ can cause serious immune reactions including inflammation of the lungs, gut, liver, kidneys, hormonal glands and skin, as well as infusion-related reactions.

The most common side effects are tiredness, muscle and bone pain, itchy skin, diarrhea, skin rash, fever, and nausea.

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

  • Sex: The occurrence of side effects was similar for females and males.
  • Race: The number of patients of races other than White was small; therefore, differences in how ZYNYZ worked among races could not be determined.
  • Age: The number of patients of <65 years was small; therefore, differences in how ZYNYZ worked among different age groups could not be determined.

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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