No new safety signals were observed in the all-comer population with TEVIMBRA + chemotherapy1
Adverse reactions (≥10%) in RATIONALE-305*
Discontinuation:
- Permanent discontinuation of TEVIMBRA in the TEVIMBRA + chemotherapy arm due to an adverse drug reaction occurred in 16% of patients
- Adverse drug reactions that resulted in permanent discontinuation in ≥1% of patients were death, fatigue, and pneumonitis
imAEs leading to discontinuation2:
- 4.2% of patients receiving TEVIMBRA + chemotherapy vs 0.2% receiving placebo + chemotherapy
- The most common (≥2 patients) imAEs leading to discontinuation of TEVIMBRA included immune-mediated pneumonitis (6 patients [1.2%]), immune-mediated colitis (5 patients [1.0%]), immune-mediated hepatitis (3 patients [0.6%]), and immune-mediated nephritis and renal dysfunction (2 patients [0.4%]). None of the imAEs led to discontinuation of placebo in ≥2 patients
*With a difference between arms of ≥5% for all grades or ≥2% for grades 3 and 4 vs placebo + chemotherapy.
†Represents a composite of multiple, related preferred terms.
1L, first line; GC, gastric cancer; imAE, immune-mediated adverse event.
References: 1. TEVIMBRA. Prescribing Information. San Mateo, CA: Beigene, Ltd.; 2025. 2. Data on file. Beigene, Ltd.