No new safety signals identified in 1L GC/GEJC*1
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
Frequently Asked Questions
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What is the safety profile of TEVIMBRA in patients with 1L GC/GEJC and PD-L1 scores ≥1%?
TEVIMBRA has a well-characterized safety profile consistent with the PD-1 inhibitor class. No new safety signals were observed in the all-comer population with TEVIMBRA + chemotherapy. Adverse reactions (≥10%) included pyrexia, rash, pruritus, and hypothyroidism.
What are the discontinuation rates with TEVIMBRA in patients with 1L GC/GEJC and PD-L1 scores ≥1%?
Permanent discontinuation of TEVIMBRA due to adverse reactions occurred in 16% of patients. Adverse reaction that resulted in discontinuation in ≥1% of patients were death, fatigue, and pneumonitis.
How should immune-mediated adverse reactions (imAEs) be managed in patients with GC/GEJC taking TEVIMBRA?
Depending on the severity of the adverse reaction, treatment with TEVIMBRA should be withheld or permanently discontinued. 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%]), and 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.
*Safety signals were consistent with those identified in 1L ESCC.
†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. BeOne Medicines USA, Inc.; 2025. 2. Data on file. BeOne, Ltd.