Imfinzi

Locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. Adults w/ metastatic NSCLC w/ no sensitising EGFR mutations or ALK +ve mutations in combination w/ tremelimumab & platinum-based chemotherapy. 1st-line treatment of adult patients w/ extensive-stage small cell lung cancer (ES-SCLC) in combination w/ etoposide & either carboplatin or cisplatin. Adults w/ unresectable or metastatic biliary tract cancer (BTC) in combination w/ cisplatin & gemcitabine. Adults w/ advanced or unresectable hepatocellular carcinoma (HCC) in combination w/ tremelimumab.

IV Monotherapy: Locally advanced NSCLC 10 mg/kg infusion over 1 hr every 2 wk or 1,500 mg every 4 wk until disease progression or unacceptable toxicity. Max duration of therapy: 12 mth. Patient weighing ≤30 kg Wt-based dosing equiv to 10 mg/kg every 2 wk as monotherapy until wt increases to >30 kg. Combination therapy: Metastatic NSCLC During platinum chemotherapy: 1,500 mg in combination w/ tremelimumab 75 mg & platinum-based chemotherapy every 3 wk (21 days) for 4 cycles (12 wk) until disease progression or unacceptable toxicity. Post-platinum chemotherapy: 1,500 mg every 4 wk as monotherapy & histology-based pemetrexed maintenance therapy every 4 wk. Give 5th dose of tremelimumab 75 mg at wk 16 w/ Imfinzi. Patient weighing ≤30 kg Wt-based dosing equiv to 20 mg/kg until wt is >30 kg; ≤34 kg Wt-based dosing equiv to tremelimumab 1 mg/kg until wt is >34 kg. ES-SCLC 1,500 mg in combination w/ chemotherapy every 3 wk (21 days) for 4 cycles, followed by 1,500 mg every 4 wk as monotherapy until disease progression or unacceptable toxicity. Patient weighing ≤30 kg 20 mg/kg in combination w/ chemotherapy every 3 wk (21 days), followed by 20 mg/kg every 4 wk as monotherapy until wt increases to >30 kg. BTC 1,500 mg infusion over 1 hr in combination w/ chemotherapy every 3 wk (21 days) up to 8 cycles followed by 1,500 mg every 4 wk as monotherapy until disease progression or unacceptable toxicity. Patient weighing ≤36 kg Wt-based dosing at 20 mg/kg in combination w/ chemotherapy every 3 wk (21 days), followed by 20 mg/kg every 4 wk as monotherapy until wt increases to >36 kg. HCC 1,500 mg in combination w/ 300 mg tremelimumab as single dose at cycle 1/day 1, followed by Imfinzi every 4 wk as monotherapy until disease progression or unacceptable toxicity. Patient weighing ≤30 kg Wt-based dosing equiv to 20 mg/kg until wt is >30 kg; ≤40 kg Wt-based dosing equiv to tremelimumab 4 mg/kg until wt is >40 kg.

Hypersensitivity.

Monitor patients for signs & symptoms of pneumonitis; colitis/diarrhoea & intestinal perforation; rash or dermatitis; immune-mediated myocarditis; immune-mediated pancreatitis; infusion-related reactions. Monitor for clinical signs & symptoms of adrenal insufficiency; type 1 DM; hypophysitis. Closely monitor patients w/ BTC for development of cholangitis or biliary tract infections before initiation of treatment & regularly, thereafter. Patients w/ a baseline ECOG performance score ≥ 2; active or prior documented autoimmune disease w/in 2 yr of initiation of study; history of immunodeficiency & severe immune-mediated adverse reactions; medical conditions requiring systemic immunosuppression, except physiological dose of systemic corticosteroids (≤10 mg/day prednisone or equiv); uncontrolled intercurrent illnesses; active TB or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine w/in 30 days before or after the start of treatment. Immune-mediated pneumonitis or ILD. SJS or TEN in patients treated w/ PD-1 inhibitors. Myasthenia gravis, myositis, polymyositis, meningitis, Guillain-Barré syndrome, immune thrombocytopenia & pancreatitis. Monitor ALT, AST, total bilirubin, & alkaline phosphatase levels prior to initiation of treatment & prior to each subsequent infusion. Monitor patients for abnormal thyroid function tests prior to & periodically during treatment. Monitor for abnormal renal function tests prior to & periodically during treatment or in combination w/ tremelimumab. Avoid driving or operating machinery if patients experience adverse reactions affecting the ability to concentrate & react. Severe renal & hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 3 mth after last dose. Not recommended during pregnancy. Lactating women should be advised not to breastfeed during treatment & for at least 3 mth after last dose. Childn <18 yr.

Pneumonia, URTI; cough/productive cough; pneumonitis; diarrhoea, abdominal pain; increased AST & ALT; rash, pruritus; pyrexia; myalgia; increased blood creatinine; peripheral oedema; infusion-related reaction. Monotherapy: Hypothyroidism; diarrhoea, abdominal pain; rash, pruritus; arthralgia. Flu, oral candidiasis, dental & oral soft tissue infections; hyperthyroidism; night sweats; dysuria. In combination w/ chemotherapy: Anaemia, leukopenia, neutropenia, thrombocytopenia; decreased appetite; constipation, nausea, vomiting; alopecia; fatigue. Febrile neutropenia, pancytopenia; adrenal insufficiency, hyper-/hypothyroidism; peripheral neuropathy; stomatitis; hepatitis; dermatitis; arthralgia.

Targeted Cancer Therapy / Cancer Immunotherapy

L01FF03 - durvalumab ; Belongs to the class of PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.

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