FDA approved Imjudo (tremelimumab) for Unresectable Hepatocellular Carcinoma and Metastatic NSCLCFDA approved new drug Imjudo for liver and lung cancers.

Imjudo is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody. CTLA-4 is a negative regulator of T-cell activity; blocking CTLA-4 enhances T-cell activation and proliferation, including antitumor immune responses.

Imjudo is indicated in combination with durvalumab for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). It is also indicated in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

Administer Imjudo as an intravenous infusion over 60 minutes after dilution. For uHCC: patients weighing 30 kg or more receive a single dose of Imjudo 300 mg followed by durvalumab 1,500 mg at Cycle 1/Day 1, then durvalumab as a single agent every 4 weeks. Patients weighing less than 30 kg receive Imjudo 4 mg/kg followed by durvalumab 20 mg/kg at Cycle 1/Day 1, then durvalumab every 4 weeks. For metastatic NSCLC: patients weighing 30 kg or more receive Imjudo 75 mg every 3 weeks in combination with durvalumab 1,500 mg and platinum-based chemotherapy for 4 cycles, then durvalumab 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of Imjudo 75 mg in combination with durvalumab dose 6 at week 16. Patients weighing less than 30 kg receive Imjudo 1 mg/kg every 3 weeks with durvalumab 20 mg/kg and chemotherapy for 4 cycles, then durvalumab 20 mg/kg every 4 weeks with pemetrexed, and a fifth dose of Imjudo 1 mg/kg at week 16. No dose reductions are recommended; manage adverse reactions by withholding or permanently discontinuing the regimen.

Trial data not available in label.

No contraindications are listed in the label. Warnings include immune-mediated adverse reactions (such as severe or fatal immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatologic reactions). For severe (Grade 3) immune-mediated reactions, withhold the regimen; for life-threatening (Grade 4) reactions, recurrent severe reactions requiring systemic immunosuppression, or inability to reduce corticosteroid dose to 10 mg or less of prednisone per day within 12 weeks, permanently discontinue. No dose reduction is recommended.

Imjudo is a CTLA-4 inhibitor used in combination regimens for two advanced cancers: unresectable HCC and metastatic NSCLC without EGFR/ALK aberrations. It is administered as part of a defined schedule with durvalumab (and chemotherapy in NSCLC). Clinicians should consider this option for eligible patients, but must be vigilant for immune-related toxicities.