PracticeUpdate Oncology February 2019

in patients with Stage III unresectable NSCLC whose disease has not progressed post platinum-based CRT IMFINZI: UNPRECEDENTED OVERALL SURVIVAL BENEFIT (vs placebo: HR 0.68; 95% CI, 0.53-0.87; P =0.0025) 1-3

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PBS Information: This product is not listed on the PBS.

CI: confidence interval; CRT: chemoradiation therapy; HR: hazard ratio; NSCLC: non-small cell lung cancer; OS: overall survival; TGA: Therapeutic Goods Administration. Stage III NSCLC is defined as locoregionally advanced disease due to primary tumour extension into extrapulmonary structures (T3 or T4) or mediastinal lymph node involvement (N2 or N3) without evidence of distant metastases (M0), including tumours greater than 5 cm in size with hilar, intrapulmonary, or peribronchial lymph node involvement (T3N1) or tumours greater than 7 cm (T4), regardless of lymph node involvement. 4 References: 1. IMFINZI Approved Product Information. 2. Antonia SJ, et al . N Engl J Med 2018;DOI: 10.1056/NEJMoa1809697. 3. McCall NS, et al. Clin Cancer Res 2018;24:1271-6. 4. Schild SE, et al. Management of stage III non-small lung cancer. UpToDate. May 30 2018. Available at: https://www.uptodate.com/contents/ management-of-stage-iii-non-small-cell-lung-cancer (accessed 6 July 2018). IMFINZI™ (durvalumab) 120mg/2.4mL or 500mg/10mL, Concentrated Solution for Infusion in a single-dose vial. Therapeutic indications: Urothelial carcinoma: Treatment of patients with locally advanced or metastatic urothelial carcinoma who: have disease progression during or following platinum-containing chemotherapy; have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved based on objective response rate and duration of response in a single arm study. An improvement in survival or disease-related symptoms has not been established. *Locally advanced non-small cell lung cancer (NSCLC): Treatment of patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy . Dose and method of administration: Urothelial carcinoma: 10 mg/kg as an intravenous (IV) infusion over 60 minutes every 2 weeks, as long as clinical benefit is observed or unacceptable toxicity. *Locally advanced NSCLC: 10 mg/kg administered as an IV infusion over 60 minutes every 2 weeks, for one year or until disease progression or unacceptable toxicity . IMFINZI should be diluted prior to infusion. See full PI for compatible diluents. Dose escalation or reduction is not recommended. Dose withholding or discontinuation may be required based on individual safety and tolerability. See full PI for guidelines for management of adverse reactions. See Warnings and Precautions section of full PI for monitoring and evaluation information. IMFINZI has not been studied in patients with severe renal impairment. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Immune-mediated adverse reactions: Immune checkpoint inhibitors, including durvalumab, can cause severe and fatal immune-mediated adverse reactions (imARs), which may involve any organ system. Patients should be monitored for signs and symptoms associated with imARs including: immune-mediated pneumonitis, hepatitis, colitis, nephritis and dermatological adverse reactions; immune-mediated endocrinopathies including hypothyroidism, hyperthyroidism, adrenal insufficiency, Type 1 diabetes mellitus, hypophysitis/hypopituitarism, and other immune-mediated adverse reactions. See full PI for further monitoring and evaluation information and for management recommendations for imARs. Monitor patients for signs and symptoms of infusion-related reactions: severe reactions have been reported. *Efficacy in patients with PD-L1 expression <1%: post-hoc analyses suggest efficacy may be different for patients with PD-L1<1% . Paediatric use: safety and efficacy not established in patients less than 18 years. Use in pregnancy: Category D. Durvalumab has the potential to impact maintenance of pregnancy and may cause foetal harm. Not recommended during pregnancy; women of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose. Use in lactation: lactating women should be advised not to breastfeed during treatment and for at least 3 months after the last dose. ADVERSE REACTIONS: Urothelial carcinoma: Very common (≥10%, any grade): fatigue, musculoskeletal pain, constipation, decreased appetite/hypophagia, nausea, anaemia, urinary tract infection, diarrhoea/colitis, liver injury, abdominal pain, acute kidney injury, rash, peripheral oedema, dyspnoea/exertional dyspnoea, cough/productive cough, pyrexia/tumour associated fever, vomiting, arthralgia, hypothyroidism, hyponatraemia, insomnia. *Locally advanced NSCLC: Very common (≥10%, any grade): cough/productive cough, pneumonitis/radiation pnemonitis, dyspnoea, diarrhoea, abdominal pain, hypothyroidism, rash, pruritus, fatigue, pyrexia, pneumonia, upper respiratory tract infections; Common (≥1% to <10%, any grade): dysphonia, dysuria, night sweats, peripheral oedema, increased susceptibility to infections. See full PI for other listed adverse reactions including immune-mediated adverse reactions. Date of first inclusion in the ARTG: 2nd October 2018. Date of most recent amendment: 23rd October 2018. *Please note changes in Product Information.

IMFINZI ™ is a trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries: 1800 805 342 or medinfo.australia@astrazeneca.com. To report an adverse event: 1800 805 342 or via https://aereporting.astrazeneca.com. Date of preparation: January 2019. WL301685. AU-5510.