Imfinzi

Unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemo- & RT. In combination w/ platinum-based chemotherapy as neoadjuvant treatment followed by monotherapy after surgery for adults w/ resectable (tumours ≥4 cm &/or node +ve) NSCLC & no known EGFR mutation or ALK rearrangements. In combination w/ tremelimumab & platinum-based chemotherapy for 1st-line treatment of adults w/ metastatic NSCLC w/ no sensitizing EGFR mutations or ALK positive mutations. In combination w/ etoposide & either carboplatin or cisplatin for 1st-line treatment of adults w/ extensive-stage small cell lung cancer (ES-SCLC). In combination w/ gemcitabine & cisplatin for 1st-line treatment of adults w/ unresectable or metastatic biliary tract cancer (BTC). In combination w/ tremelimumab for 1st line treatment of adults w/ advanced or unresectable hepatocellular carcinoma (HCC). In combination w/ carboplatin & paclitaxel for 1st-line treatment of adults w/ primary advanced or recurrent endometrial cancer who are candidates for systemic therapy followed by maintenance monotherapy or in combination w/ olaparib in mismatch repair deficient (dMMR) endometrial cancer.

Administer as IV infusion over 60 min. Unresectable NSCLC Patient >30 kg 10 mg/kg IV infusion over 60 min every 2 wk or 1,500 mg IV infusion over 60 min every 4 wk until disease progression, unacceptable toxicity or max: 12 mth, patient ≤30 kg 10 mg/kg IV infusion over 60 min every 2 wk until wt increase to >30 kg. Resectable NSCLC Patient >30 kg Neoadjuvant: 1,500 mg in combination w/ chemotherapy every 3 wk for up to 4 cycles prior to surgery until disease progression, recurrence, unacceptable toxicity or max: 12 cycles. Adjuvant: 1,500 mg as single agent every 4 wk for up to 12 cycles, patient ≤30 kg Neoadjuvant: 20 mg/kg every 3 wk in combination w/ chemotherapy for up to 4 cycles prior to surgery. Adjuvant: 20 mg/kg as single agent every 4 wk for up to 12 cycles until wt increase to >30 kg. Resectable NSCLC During platinum chemotherapy: 1,500 mg in combination w/ tremelimumab 75 mg & platinum-based chemotherapy every 3 wk for 4 cycles until disease progression or unacceptable toxicity. Post-platinum chemotherapy: 1,500 mg as monotherapy every 4 wk & histology-based pemetrexed maintenance therapy every 4 wk then 5th dose of tremelimumab 75 mg given at wk 16. ES-SCLC Patient >30 kg 1,500 mg in combination w/ chemotherapy every 3 wk for 4 cycles, followed by 1,500 mg every 4 wk as monotherapy until disease progression or unacceptable toxicity, patient ≤30 kg 20 mg/kg in combination w/ chemotherapy every 3 wk for 4 cycles, followed by 20 mg/kg every 4 wk as monotherapy until wt increase to >30 kg. BTC Patient >36 kg 1,500 mg in combination w/ chemotherapy every 3 wk for 8 cycles, followed by 1,500 mg every 4 wk as monotherapy until disease progression or unacceptable toxicity, patient ≤36 kg 20 mg/kg in combination w/ chemotherapy every 3 wk for 8 cycles, followed by 20 mg/kg every 4 wk as monotherapy until wt increase to >36 kg. HCC 1,500 mg in combination w/ tremelimumab 300 mg as single dose at cycle 1/day 1 followed by monotherapy every 4 wk until disease progression or unacceptable toxicity. Endometrial cancer Patient >30 kg 120 mg in combination w/ carboplatin & paclitaxel every 3 wk for min: 4 & up to 6 cycles, followed by 500 mg every 4 wk as monotherapy or in combination w/ olaparib 300 mg bd until disease progression or unacceptable toxicity, patient ≤30 kg 15 mg/kg in combination w/ carboplatin & paclitaxel every 3 wk for min: 4 & up to 6 cycles, followed by 20 mg/kg every 4 wk as monotherapy or in combination w/ olaparib 300 mg bd until wt increase >30 kg.

Monitor patients for signs & symptoms of pneumonitis, hepatitis, colitis or diarrhea, nephritis, rash or dermatitis, myocarditis, infusion-related reactions. Endocrinopathies eg, thyroid disorders, adrenal insufficiency, type 1 DM & hypophysitis/hypopituitarism; other immune-mediated adverse reactions eg, myasthenia gravis, myelitis transverse, myositis, polymyositis, rhabdomyolysis, Guillain-Barre syndrome, immune thrombocytopenia, pancreatitis, arthritis, uveitis, encephalitis. Pure red cell aplasia (PRCA), autoimmune haemolytic anemia. Immunogenicity. Monitor abnormal hepatic, renal & thyroid function tests prior to & periodically during treatment. Women of childbearing potential should use effective contraception during & at least 3 mth after last dose. Pregnancy. Not to be used during lactation. Ped patients.

Pneumonitis/radiation pneumonitis, hepatitis, colitis, endocrinopathies, nephritis, rash, other immune-mediated adverse reactions, infusion-related reactions. Nausea, fatigue/asthenia. NSCLC & endometrial cancer: Anemia. NSCLC, BTC & endometrial cancer: Constipation, rash. BTC & endometrial cancer: Decreased appetite, abdominal pain. SCLC & endometrial cancer: Alopecia. NSCLC: Musculoskeletal pain, cough, pneumonitis or radiation pneumonitis, URTI, dyspnea. BTC: Pyrexia. Endometrial cancer: Neutropenia, thrombocytopenia, leukopenia, diarrhoea, vomiting, peripheral neuropathy.

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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