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%])
*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. San Mateo, CA: Beigene, Ltd.; 2025. 2. Data on file. Beigene, Ltd.