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Drug Trials Snapshots: TEVIMBRA

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 TEVIMBRA 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).

TEVIMBRA (tislelizumab-jsgr)
(Teh-vim’-brah)
BeiGene
Approval date: March 14, 2024


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

TEVIMBRA is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of adults with a type of esophageal cancer called esophageal squamous cell carcinoma (ESCC) that has spread to other parts of the body (metastatic) or cannot be completely removed by surgery (unresectable). It is approved to treat patients who have undergone prior treatment with chemotherapy for their ESCC that did not include a PD-1 blocking antibody.

How is this drug used?

TEVIMBRA is an injection given by a healthcare professional directly into the vein (an intravenous infusion) over 30 to 60 minutes every three weeks.

Who participated in the clinical trials?

The FDA approved TEVIMBRA based on evidence from one clinical trial (RATIONALE-302, NCT03430843) that enrolled 512 patients with previously treated unresectable or metastatic ESCC. Patients did not receive prior treatment with immune checkpoint inhibitors, a type of drugs that are similar to TEVIMBRA. The trial was conducted at 132 medical centers in 11 countries in Asia, Europe, and the United States (only two patients were enrolled in the United States).

How were the trials designed?

The RATIONALE-302 trial enrolled patients with previously treated unresectable or metastatic ESCC that did not receive prior treatment with immune checkpoint inhibitors. Patients received either TEVIMBRA or chemotherapy every three weeks. Treatment continued until progression of disease or development of intolerable side effects. The trial measured the length of time that patients survived while receiving TEVIMBRA compared to chemotherapy.


DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many males and females were enrolled in the TEVIMBRA clinical trial.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 432 (84%) male patients and 80 (16%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes how many patients by race were enrolled in the TEVIMBRA clinical trial.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, and other, not reported, or unknown patients were in the clinical trial. In total, 97 (18.9%) White patients, 2 (0.4%) Black or African American patients, 408 (79.7%) Asian patients, and 5 (1.0%) other, not reported, or unknown patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3 summarizes how many patients by age were enrolled in the TEVIMBRA clinical trial.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 318 (62%) patients younger than 65 years of age and 194 (38%) patients 65 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes how many patients by ethnicity were enrolled in the TEVIMBRA clinical trial.

Figure 4. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic, not Hispanic, and not reported or unknown patients were in the clinical trial. In total, 4 (1%) Hispanic or Latino patients, 504 (98%) not Hispanic or Latino patients, and 4 (1%) not reported or unknown patients participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

In the RATIONALE-302 trial, the median overall survival for patients treated with TEVIMBRA was about 8.6 months compared to 6.3 months for patients treated with chemotherapy.

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

  • Sex: TEVIMBRA worked similarly in males and females.
  • Race: The majority of patients were Asian or White. TEVIMBRA 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: TEVIMBRA worked similarly in patients younger and older than 65 years of age.

What are the possible side effects?

TEVIMBRA may cause serious and potentially deadly immune reactions including inflammation of the lungs (pneumonitis), gut, liver, kidneys, hormonal glands, and skin as well as infusion related reactions. The most common side effects (≥20% of patients) were anemia (low red blood cell count), fatigue, musculoskeletal pain, decreased weight, and cough.

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

  • Sex: The occurrence of side effects was similar in males and females. Females treated with TEVIMBRA experienced more fatigue and diarrhea than males.
  • Race: The majority of patients were Asian. White patients treated with TEVIMBRA experienced more fever, decreased appetite, nausea, fatigue, diarrhea, dysphagia, and asthenia than Asian patients.
  • Age: The occurrence of side effects was similar in patients younger and older than 65 years of age. Patients 65 years or older experienced more fever and diarrhea than younger patients.

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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