Imjudo

Tremelimumab

In combination w/ durvalumab for patients w/ unresectable hepatocellular carcinoma (uHCC) who have not received prior systemic therapy.

IV uHCC 300 mg infusion over 1 hr as a single priming dose in combination w/ durvalumab 1,500 mg at cycle 1/day 1, followed by durvalumab every 4 wk as monotherapy. Patient weighing ≤30 kg Wt-based dosing at 4 mg/kg & in combination w/ durvalumab 20 mg/kg until wt is >30 kg.

Hypersensitivity.

Not recommended to reduce or escalate dose during treatment (in combination w/ durvalumab). W/holding or discontinuation may be required based on individual safety & tolerability. Permanently discontinue use for recurrent Grade 3 AR as applicable. W/hold or permanently discontinue durvalumab if AST & ALT are ≤ to ULN at baseline in patients w/ liver involvement. Promptly start additional immunosuppressive therapy if no improvement w/in 2-3 days despite corticosteroids; taper corticosteroids & continue over at least 1 mth upon resolution (Grade 0). Permanently discontinue use if AR does not resolve to ≤ Grade 1 w/in 30 days or if there are resp insufficiency signs. Perform adequate evaluation to confirm or exclude alternate etiologies for suspected immune-mediated AR. W/hold use for Grade 2 & 3 AR until ≤ Grade 1 or baseline for non-immune-mediated AR. Discontinue use for Grade 4 AR w/ exception of Grade 4 lab abnormalities (decision to discontinue should be based on accompanying signs/symptoms & clinical judgment). Monitor for signs & symptoms of pneumonitis, colitis or diarrhoea, intestinal perforation, adrenal insufficiency, type 1 DM (which can present w/ diabetic ketoacidosis), hypophysitis or hypopituitarism, rash or dermatitis (including pemphigoid), immune-mediated myocarditis, other potential immune-mediated AR (eg, myasthenia gravis, myositis, polymyositis, Guillain-Barré syndrome, meningitis, noninfective cystitis, immune thrombocytopenia, pancreatitis, hemophagocytic lymphohistiocytosis, autoimmune hemolytic anemia, aplastic anemia, immune-mediated arthritis, uveitis, encephalitis) & infusion-related reactions; abnormal liver, renal & thyroid function tests prior to & periodically during treatment. Possible cytomegalovirus infection/reactivation in patients w/ corticosteroid-refractory immune-mediated colitis. Possible SJS or TEN; iritis & other ocular inflammatory toxicities. Advise patients who experience AR affecting their ability to concentrate & react to use caution when driving or operating machinery. Severe renal & hepatic impairment. Not recommended during pregnancy & in women of childbearing potential not using effective contraception during treatment & for at least 3 mth after the last dose. Advise lactating women not to breastfeed during treatment & for at least 3 mth after the last dose. Childn & adolescents <18 yr.

Hypothyroidism; abdominal pain, diarrhoea; peripheral oedema, pyrexia; increased AST & ALT; cough/productive cough; pruritus, rash. Adrenal insufficiency, hyperthyroidism, thyroiditis; increased amylase & lipase, colitis, pancreatitis; hepatitis; dental & oral soft tissue infections, flu, pneumonia, URTI; infusion-related reaction; myalgia; increased blood creatinine, dysuria; pneumonitis; dermatitis, night sweats.

Not recommended due to potential interference w/ pharmacodynamic activity & efficacy w/ the use of systemic corticosteroids/immunosuppresants before starting treatment (except physiological dose of systemic corticosteroids of ≤10 mg/day prednisone or equivalent).

Cancer Immunotherapy

L01FX20 - tremelimumab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

POM