If you or a loved one has esophageal cancer, you may be looking at different treatment options. One medicine you may hear about is Tevimbra (tislelizumab-jsgr). It is an immunotherapy medicine that is designed to help your immune system find and attack cancer cells.
Tevimbra is used to treat a type of esophageal cancer called esophageal squamous cell carcinoma (ESCC). This cancer starts in the thin, flat cells that line the inside of the esophagus, which is the tube that carries food to your stomach.
Tevimbra is also FDA-approved for other types of cancer. This article focuses on Tevimbra’s use for esophageal cancer. Continue reading to learn more about Tevimbra for esophageal cancer, how it works, how it’s given, and possible benefits.
Is Tevimbra Right for My Esophageal Cancer?
Tevimbra is FDA-approved to treat ESCC that cannot be removed with surgery (unresectable) or has spread to other parts of the body (metastatic). It can be used alone or in combination with chemotherapy, depending on certain factors:
- If Tevimbra is your first treatment for your esophageal cancer, it is usually given with a platinum-containing chemotherapy medicine. Your tumor must also test positive for PD-L1 — a protein that can help cancer cells hide from the immune system. A tumor sample can be tested to see whether it has a certain level of PD-L1.
- Tevimbra may be used alone if your esophageal cancer has already been treated with a chemotherapy regimen that did not include a type of immunotherapy called a PD-1 inhibitor or a PD-L1 inhibitor. (A positive PD-L1 test is not required for this use.)
Your oncologist can discuss your previous treatments, test results, overall health, and other factors to decide whether Tevimbra may be a good treatment option for you.
How Does Tevimbra Work?
Tevimbra is a type of immunotherapy called a checkpoint inhibitor. It blocks a protein called PD-1, which is found on immune cells called T cells.
Normally, proteins called PD-L1 and PD-L2 can attach to PD-1 and send signals that reduce T-cell activity. Some tumors use this pathway to avoid being attacked by the immune system.
Tevimbra attaches to PD-1 and blocks PD-L1 and PD-L2 from binding to it. This releases some of the “brakes” on the immune response, which can help T cells find and attack cancer cells.
How Is Tevimbra Given?
Tevimbra is given by a health care provider as an IV infusion into a vein. Depending on the dose you receive, it may be given once every two, three, four, or six weeks. Your health care team can give you the details about your dosage and treatment schedule.
Your Tevimbra infusion may take about 30-120 minutes, depending on the dose and how well your body tolerates the medicine. The first infusion generally takes longer. If you tolerate it well, later infusions may be shorter.
You may continue receiving Tevimbra until your cancer gets worse or until side effects make it unsafe to continue. Tell your health care provider right away if you have new or unusual symptoms during or after Tevimbra treatment. If you have certain side effects, your health care provider may pause treatment or stop Tevimbra permanently. You will also need to have blood tests during treatment to check for side effects.
To learn more, see our article about managing Tevimbra side effects.
How Was Tevimbra Studied for Esophageal Cancer?
Two main clinical trials were done to test how well Tevimbra works for treating esophageal cancer, specifically ESCC. One trial studied Tevimbra as a first treatment along with chemotherapy. The other studied Tevimbra by itself in people who had already received chemotherapy in the past.
Tevimbra as first-line treatment:
RATIONALE-306 looked at Tevimbra plus chemotherapy as a first treatment for advanced ESCC.
The study included 649 adults with ESCC that could not be removed with surgery, had come back, or had spread to other parts of the body (metastatic). People could join the study regardless of their tumor’s PD-L1 level.
Here are some details about the 649 adults who joined the study:
- Participants lived in Asia, Europe, Oceania, and North America. Most were from Asia.
- The median (middle) age of participants was 64, with ages ranging from 26 to 84.
- 87% were men, and 13% were women.
- Most (75%) were Asian, and 24% were White. Race/ethnicity details were not publicly reported for the remaining 1%.
- Most (86%) had metastatic cancer (that had spread to other body parts) when the study began.
Participants were randomly assigned to one of two treatment groups: One group received Tevimbra plus chemotherapy, the other received a placebo plus chemotherapy. A placebo does not contain active medicine. Neither the participants nor the researchers knew who was receiving Tevimbra during the study.
The chemotherapy regimen included a platinum drug, such as cisplatin or oxaliplatin, along with another chemotherapy medicine. Treatment continued until the cancer got worse or side effects made it unsafe to continue. Participants had scans every six or nine weeks to check their cancer.
The main goal of the study was to compare overall survival (OS), meaning how long people lived. Researchers also looked at how long people lived without their cancer getting worse (progression-free survival, or PFS) and how many people responded to treatment (overall response rate, or ORR). A response means the tumor shrinks or disappears.
Tevimbra after previous chemotherapy:
A separate study called RATIONALE-302 included adults with advanced ESCC that had spread or could not be removed by surgery and had worsened during or after previous chemotherapy treatment.
People could join the study regardless of their PD-L1 level. Here are some details about the 512 adults who took part in the study:
- Participants lived in Asia, Europe, or North America. Most were from Asia.
- The median age of participants was 62, with ages ranging from 35 to 86.
- About 84% were men, and 16% were women.
- About 80% were Asian, 19% were White, and less than 1% were Black/African American, other, unknown race, or not reported.
- Most (95%) had metastatic cancer when the study began.
Participants were randomly assigned to receive either Tevimbra by itself or one of three chemotherapy medicines (docetaxel, irinotecan, or paclitaxel). Treatment continued until the cancer got worse or side effects made it unsafe to continue. Participants had scans every six or nine weeks to check their cancer.
The main goal was to compare overall survival between the Tevimbra and chemotherapy groups.
What Are the Benefits of Tevimbra for Esophageal Cancer Based on Studies?
Both studies showed that Tevimbra helped people with advanced ESCC live longer than the treatments it was compared with.
The table below summarizes the main results.
| Study | Treatment | Median overall survival |
|---|---|---|
| RATIONALE-306 | Tevimbra + chemotherapy | 17.2 months |
| Placebo + chemotherapy | 10.6 months | |
| RATIONALE-302 | Tevimbra alone | 8.6 months |
| Chemotherapy alone | 6.3 months |
Both studies enrolled people regardless of their PD-L1 levels, but researchers also looked at results in groups with certain PD-L1 levels. (Remember that PD-L1 is a protein that can help cancer cells hide from the immune system.) A PD-L1 TAP score measures how much of the tumor area contains tumor cells or immune cells with PD-L1. TAP stands for Tumor Area Positivity.
Results of the RATIONALE-306 study showed that the OS benefit was mainly linked to results in people who had a PD-L1 TAP score of at least 1%. Among this subgroup:
- OS: Median OS was 16.8 months with Tevimbra plus chemotherapy and 9.6 months with placebo plus chemotherapy.
- PFS: Median PFS was 7.2 months with Tevimbra plus chemotherapy and 5.5 months with placebo plus chemotherapy.
- ORR: Tumors shrank or disappeared in 58% of people who received Tevimbra plus chemotherapy and 36% of people who received placebo plus chemotherapy.
Based on these results, Tevimbra is FDA-approved as a first treatment for people with a PD-L1 TAP score of at least 1%, in combination with chemotherapy.
The RATIONALE-302 researchers also looked separately at people with a higher PD-L1 TAP score of at least 10%. In this group, median OS was 10.3 months with Tevimbra and 6.8 months with chemotherapy.
However, Tevimbra’s FDA-approved use after previous chemotherapy does not require a specific PD-L1 level.
Your results may differ from what was seen in clinical studies.
What Is Its Place in Therapy?
According to treatment guidelines for esophageal cancer from the National Comprehensive Cancer Network (NCCN), Tevimbra is one of the preferred treatment options for ESCC that cannot be removed by surgery, has spread, or has come back. NCCN describes preferred treatments as those with the most evidence that they may work better and be safer than other treatments.
The best choice for you depends partly on which treatments you have already received, your overall health, and certain features of your cancer.
Your health care provider can help decide where Tevimbra may fit into your treatment plan.
Is There Any Cost Assistance Available?
Cost assistance is available from BeOne Medicines, the maker of Tevimbra. It may reduce the cost of your medicine. Eligible insured patients may pay $0 with a Tevimbra copay savings card. To learn more, visit this website or call 833-234-4363.
