A well-characterized safety profile, consistent with the PD-1 inhibitor class1
Adverse reactions (≥10%) in RATIONALE-306*
Discontinuation1:
- Permanent discontinuation of TEVIMBRA due to adverse reactions occurred in 13% of patients
- Adverse reaction that resulted in discontinuation in ≥2% of patients was pneumonitis
imAEs leading to discontinuation2:
- 4.9% of patients receiving TEVIMBRA + chemotherapy vs 0.6% of patients receiving placebo + chemotherapy
- The most common (≥2 patients in either arm) imAEs leading to discontinuation of TEVIMBRA or placebo included immune-mediated pneumonitis (8 patients [2.5%] in the TEVIMBRA + chemotherapy arm vs 2 [0.6%] in the placebo + chemotherapy arm), immune-mediated skin adverse reaction (2 patients [0.6%] vs 0 patients [0.0%])
Frequently Asked Questions
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What is the safety profile of TEVIMBRA in patients with 1L ESCC?
TEVIMBRA has a well-characterized safety profile, consistent with the PD-1 inhibitor class. Adverse reactions (≥10%) included anemia, neutropenia, fatigue, decreased appetite, diarrhea, stomatitis, vomiting, dysphagia, rash, pruritus, and hypothyroidism.1
What are the discontinuation rates with TEVIMBRA in patients with 1L ESCC?
Permanent discontinuation of TEVIMBRA due to adverse reactions occurred in 13% of patients. Adverse reaction that resulted in discontinuation in ≥2% of patients was pneumonitis.1
How should imAEs be managed in patients with ESCC taking TEVIMBRA?
Depending on the severity of the adverse reaction, treatment with TEVIMBRA should be withheld or permanently discontinued. The most common (≥2 patients in either arm) imAE leading to discontinuation of TEVIMBRA or placebo included immune-mediated pneumonitis (8 patients [2.5%] in the TEVIMBRA + chemotherapy arm vs 2 [0.6%] in the placebo + chemotherapy arm).1,2
*With a difference between arms of ≥5% for all grades or ≥2% for grades 3 and 4.
†Represents a composite of multiple, related preferred terms.
1L, first line; 2L, second line; ESCC, esophageal squamous cell carcinoma; imAE, immune-mediated adverse event; PD-1, programmed death receptor 1; PD-L1, programmed death ligand 1; TEAE, treatment-emergent adverse event.
References: 1. TEVIMBRA. Prescribing Information. BeOne Medicines USA, Inc.; 2025. 2. Data on file. BeOne, Ltd.