Imjudo

1st line treatment of adults w/ advanced or unresectable hepatocellular carcinoma (HCC) in combination w/ durvalumab. 1st line treatment of adults w/ metastatic NSCLC w/ no sensitizing epidermal growth factor receptor mutations or anaplastic lymphoma kinase +ve mutations in combination w/ durvalumab & platinum-based chemotherapy.

IV Infuse over 1 hr. Advanced or unresectable HCC 300 mg as single dose in combination w/ durvalumab 1,500 mg at cycle 1/day 1, followed by durvalumab monotherapy every 4 wk. Duration of therapy: Until disease progression or unacceptable toxicity. Patient weighing ≤40 kg 4 mg/kg until wt is >40 kg. Metastatic NSCLC During platinum chemotherapy: 75 mg in combination w/ durvalumab 1,500 mg & platinum-based chemotherapy every 3 wk (21 days) for 4 cycles (12 wk). Post-platinum chemotherapy: Durvalumab 1,500 mg every 4 wk & histology-based pemetrexed maintenance therapy every 4 wk. A 5th dose of Imjudo 75 mg should be given at wk 16 alongside durvalumab dose 6. Max: 5 doses. Patient weighing ≤34 kg 1 mg/kg until wt is >34 kg.

Hypersensitivity.

Monitor for signs & symptoms of pneumonitis; colitis/diarrhoea & intestinal perforation; adrenal insufficiency; type 1 DM; hypophysitis or hypopituitarism; rash or dermatitis; immune-mediated myocarditis; immune-mediated pancreatitis; other immune-mediated adverse reactions (myasthenia gravis, myositis, polymyositis, meningitis, encephalitis, Guillain-Barré syndrome, immune thrombocytopenia, cystitis noninfective); infusion-related reactions. Monitor ALT, AST, total bilirubin, & alkaline phosphatase levels prior to initiation of treatment & prior to each subsequent infusion. Monitor for abnormal thyroid function tests prior to & periodically during treatment & as indicated based on clinical evaluation. Monitor for abnormal renal function tests prior to & periodically during treatment. Not recommended during pregnancy & in women of childbearing potential not using effective contraception during treatment & for at least 3 mth after the last dose. Discontinue breast-feeding during treatment & for at least 3 mth after the last dose. Safety & efficacy in childn & adolescents <18 yr have not been established. Advanced or unresectable HCC: Caution in patients w/ Child-Pugh score B or C, main portal vein thrombosis, liver transplant, uncontrolled HTN, history of or current brain metastases, spinal cord compression, co-infection of viral hepatitis B & C, active or prior documented GI bleeding w/in 12 mth, ascites requiring non-pharmacologic intervention w/in 6 mth, hepatic encephalopathy w/in 12 mth before treatment start, active or prior documented autoimmune or inflammatory disorders. Metastatic NSCLC: Caution in patients w/ active or prior documented autoimmune disease; active &/or untreated brain metastases; history of immunodeficiency; administration of systemic immunosuppression w/in 14 days before treatment start, except physiological dose of systemic corticosteroids (≤10 mg daily prednisone or equiv); uncontrolled intercurrent illness; active TB or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine w/in 30 days before or after treatment start. Limited data in elderly patients ≥75 yr treated w/ tremelimumab in combination w/ durvalumab & platinum-based chemotherapy.

In combination therapy: URTI, pneumonia; anaemia, neutropenia, thrombocytopenia, leukopenia; hypothyroidism; decreased appetite; cough/productive cough; nausea, diarrhoea, constipation, vomiting; increased AST & ALT; alopecia, rash, pruritus; arthralgia; fatigue, pyrexia. Flu, oral candidiasis; febrile neutropenia, pancytopenia; hyperthyroidism, adrenal insufficiency, hypopituitarism/hypophysitis, thyroiditis; peripheral neuropathy; pneumonitis, dysphonia; stomatitis, increased amylase or lipase, abdominal pain, colitis, pancreatitis; hepatitis; myalgia; increased blood creatinine, dysuria; oedema peripheral; infusion-related reaction.

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

Targeted Cancer Therapy / Cancer Immunotherapy

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

Rx