Tremelimumab blocks CTLA-4, a negative regulator of T-cell activity, enhancing immune response against tumors.

IMJUDO is a CTLA-4 blocking antibody indicated for:

• Unresectable Hepatocellular Carcinoma (uHCC):

  • Used in combination with durvalumab.

• Metastatic Non-Small Cell Lung Cancer (NSCLC):

  • Used with durvalumab and platinum-based chemotherapy.

  • Only for patients without EGFR mutations or ALK genomic aberrations.

uHCC

• ≥30 kg: IMJUDO 300 mg IV (single dose) + durvalumab 1500 mg on Cycle 1, Day 1. Then durvalumab every 4 weeks.
• <30 kg: IMJUDO 4 mg/kg + durvalumab 20 mg/kg, same schedule.

Metastatic NSCLC

• ≥30 kg: IMJUDO 75 mg every 3 weeks for 4 cycles with durvalumab 1500 mg and chemotherapy. Fifth IMJUDO dose at week 16.
• <30 kg: IMJUDO 1 mg/kg and durvalumab 20 mg/kg following same schedule.

Administration Instructions

• IV infusion over 60 minutes.

Common (≥20%) – uHCC (HIMALAYA Study)

• Rash (32%)
• Diarrhea (27%)
• Fatigue (26%)
• Pruritus, abdominal pain, musculoskeletal pain

Common (≥20%) – Metastatic NSCLC (POSEIDON Study)

• Nausea (42%)
• Fatigue (36%)
• Musculoskeletal pain (29%)
• Decreased appetite, rash, diarrhea

None

mmune-Mediated Adverse Reactions (can be fatal):

• Pneumonitis
• Colitis
• Hepatitis
• Endocrinopathies (e.g., hypothyroidism, adrenal insufficiency)
• Nephritis
• Severe dermatologic reactions (e.g., SJS, TEN)
• Pancreatitis

Embryo-Fetal Toxicity

• May cause fetal harm. Avoid in pregnancy; use contraception for 3 months post-treatment.