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A well-characterized safety profile in patients with 2L ESCC1

Adverse reactions (≥10%) in RATIONALE-302

TRAEs leading to discontinuation2:

  • 6.7% of patients receiving etapidi vs 13.8% of patients receiving chemotherapy
  • TRAEs (≥1%) leading to permanent discontinuation of etapidi were immune-mediated pneumonitis and pneumonitis

imAEs leading to discontinuation2:

  • 4.2% of patients receiving etapidi + chemotherapy vs 0.2% receiving placebo + chemotherapy
  • The most common (≥2 patients) imAEs leading to discontinuation of etapidi 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
View OS results in 2L ESCC
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*Fatigue included asthenia and malaise.

†Musculoskeletal pain included musculoskeletal pain, spinal pain, arthralgia, back pain, neck pain, musculoskeletal chest pain, myalgia, pain in extremity, noncardiac chest pain, bone pain, and arthritis.

‡Cough included productive cough and cough.

§Pneumonia included pneumonia aspiration, pneumonia bacterial, and lower respiratory tract infection.

||Diarrhea included diarrhea.

¶Abdominal pain included abdominal pain upper, abdominal pain, abdominal discomfort, abdominal pain lower, and gastrointestinal pain.

#Hypothyroidism included hypothyroidism and blood thyroid stimulating hormone increased.

**Rash included dermatitis, dermatitis acneiform, dermatitis allergic, eczema, erythema, psoriasis, rash, rash follicular, rash maculopapular, and rash pruritic.

††Hemorrhage included tumor hemorrhage, upper gastrointestinal hemorrhage, gastrointestinal hemorrhage, hemoptysis, esophageal hemorrhage, hematuria, gastric hemorrhage, epistaxis, tracheal hemorrhage, gingival bleeding, pulmonary hemorrhage, procedural hemorrhage, rectal hemorrhage, and stoma site hemorrhage.

2L, second line; ESCC, esophageal squamous cell carcinoma; imAE, immune-mediated adverse event; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.


References: 1. etapidi. Prescribing Information. BeOne Medicines USA, Inc.; 2025. 2. Data on file. BeOne, Ltd.