Imfinzi

In combination w/ chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy after surgery for adults w/ resectable (tumours ≥4 cm &/or node +ve) NSCLC & no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Monotherapy for locally advanced, unresectable NSCLC whose disease has not progressed following definitive platinum-based chemoradiation therapy. In combination w/ tremelimumab & platinum-based chemotherapy in adults w/ metastatic NSCLC w/ no sensitizing EGFR mutations or ALK genomic tumor aberrations. Monotherapy for adults w/ limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy & RT (cCRT). 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/ tremelimumab in adults w/ unresectable hepatocellular carcinoma (uHCC). In combination w/ gemcitabine & cisplatin in adults w/ locally advanced or metastatic biliary tract cancer (BTC). In combination w/ carboplatin & paclitaxel followed by durvalumab as monotherapy for adults w/ primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). In combination w/ cisplatin-based chemotherapy as neoadjuvant treatment followed by durvalumab as adjuvant monotherapy after radical cystectomy for adults w/ muscle invasive bladder cancer (MIBC).

IV Infuse over 60 min. Resectable NSCLC Patient weighing ≥30 kg 1,500 mg in combination w/ chemotherapy every 3 wk for up to 4 cycles prior to surgery, followed by 1,500 mg monotherapy every 4 wk for up to 12 cycles after surgery, <30 kg 20 mg/kg every 3 wk in combination w/ chemotherapy for up to 4 cycles prior to surgery, followed by 20 mg/kg every 4 wk for up to 12 cycles as monotherapy after surgery until disease progression precludes definitive surgery, recurrence, unacceptable toxicity, or max of 12 cycles after surgery. Unresectable stage III NSCLC Patient weighing ≥30 kg 10 mg/kg every 2 wk or 1,500 mg every 4 wk following cCRT, <30 kg 10 mg/kg every 2 wk following cCRT until disease progression, unacceptable toxicity, or max of 12 mth. LS-SCLC Patient weighing ≥30 kg 1,500 mg every 4 wk following cCRT, <30 kg 20 mg/kg every 4 wk following cCRT until disease progression, unacceptable toxicity, or max of 12 mth. ES-SCLC Patient weighing ≥30 kg 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, <30 kg 20 mg/kg in combination w/ chemotherapy every 3 wk (21 days) for 4 cycles, followed by 10 mg/kg every 2 wk as monotherapy until disease progression or unacceptable toxicity. BTC Patient weighing ≥30 kg 1,500 mg in combination w/ chemotherapy every 3 wk (21 days) for 8 cycles, followed by 1,500 mg every 4 wk as monotherapy, <30 kg 20 mg/kg in combination w/ chemotherapy every 3 wk (21 days) up to 8 cycles, followed by 20 mg/kg every 4 wk as monotherapy until disease progression or unacceptable toxicity. uHCC Patient weighing ≥30 kg 1,500 mg following single dose of tremelimumab 300 mg at day 1 of cycle 1. Continue 1,500 mg as monotherapy every 4 wk, <30 kg 20 mg/kg following single dose of tremelimumab 4 mg/kg at day 1 of cycle 1. Continue 20 mg/kg as monotherapy every 4 wk until disease progression or unacceptable toxicity. dMMR endometrial cancer Patient weighing ≥30 kg 1,120 mg in combination w/ carboplatin & paclitaxel every 3 wk (21 days) for 6 cycles, followed by 1,500 mg every 4 wk as monotherapy, <30 kg 15 mg/kg in combination w/ carboplatin & paclitaxel every 3 wk (21 days) for 6 cycles, followed by 20 mg/kg every 4 wk as monotherapy until disease progression or unacceptable toxicity. MIBC Patient weighing ≥30 kg 1,500 mg in combination w/ chemotherapy every 3 wk for up to 4 cycles prior to surgery, followed by 1,500 mg monotherapy every 4 wk for up to 8 cycles after surgery, <30 kg 20 mg/kg in combination w/ chemotherapy every 3 wk for 4 cycles prior to surgery, followed by 20 mg/kg as monotherapy every 4 wk for up to 8 cycles after surgery until disease progression precludes definitive surgery, recurrence, or unacceptable toxicity or max of 8 cycles after surgery. In combination w/ tremelimumab & platinum-based chemotherapy for metastatic NSCLC Patient w/ non-squamous or squamous tumor histology weighing ≥30 kg 1,500 mg durvalumab + 75 mg tremelimumab w/ carboplatin & nab-paclitaxel, or carboplatin or cisplatin & pemetrexed (non-squamous)/gemcitabine (squamous), <30 kg 20 mg/kg durvalumab + 1 mg/kg tremelimumab w/ carboplatin & nab-paclitaxel, or carboplatin or cisplatin & pemetrexed (non-squamous)/gemcitabine (squamous). Dosage schedule: Dosing interval of every 3 wk to every 4 wk starting cycle 5. Continue treatment until disease progression or intolerable toxicity. Give remaining cycles of tremelimumab (up to total of 5) every 4 wk after platinum-based chemotherapy phase in combination w/ durvalumab, if patient receives fewer than 4 cycles of platinum-based chemotherapy.

Hypersensitivity.

Permanently discontinue treatment in life-threatening (Grade 4) & recurrent severe (Grade 3) immune-mediated reactions. Discontinue treatment in Grade 4 non-immune-mediated adverse reactions (w/ exception of Grade 4 lab abnormalities); in combination w/ olaparib if pure red cell aplasia or autoimmune haemolytic anaemia is confirmed. Withhold treatment in severe (Grade 3) immune-mediated adverse reactions, & Grade 2 & 3 non-immune-mediated adverse reactions. Immune-mediated pneumonitis or ILD, hepatitis, hypothyroidism, hyperthyroidism or thyroiditis, & nephritis. Patients treated w/ PD-1/PD-L1 inhibitors. Monitor for signs & symptoms of pneumonitis or radiation pneumonitis, colitis/diarrhoea or intestinal perforation, adrenal insufficiency, type 1 DM, hypophysitis or hypopituitarism, rash or dermatitis (including pemphigoid), immune-mediated myocarditis, other immune-mediated adverse reactions (eg, myasthenia gravis, myositis, polymyositis, rhabdomyolysis, Guillain-Barré syndrome, immune thrombocytopenia, pancreatitis, immune-mediated arthritis, uveitis & encephalitis), & infusion-related reactions. Monitor for abnormal liver, thyroid & renal function tests prior to, & periodically during treatment. May affect ability to drive & use machines. Severe hepatic impairment. Not recommended during pregnancy & in women of childbearing potential not using effective contraception during treatment & for at least 3 mth after last dose. Not to breastfeed during treatment & for at least 3 mth after last dose. Childn & adolescents <18 yr.

Cough/productive cough; abdominal pain, diarrhoea; hypothyroidism; rash, pruritus; pyrexia; URTI. Pneumonitis, dysphonia; increased AST or ALT; hyperthyroidism; increased blood creatinine, dysuria; night sweats; peripheral oedema; pneumonia, oral candidiasis, dental & oral soft tissue infections, flu; myalgia; infection-related reaction.

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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