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This website is intended for UK Healthcare professionals only. Other UK residents please visit astrazeneca.co.uk
The safety profile of IMFINZI as a monotherapy is based on pooled data in 3006 patients in clinical trials across multiple tumour types, including locally advanced, unresectable non-small cell lung cancer (NSCLC) in the PACIFIC Study.1 In all clinical trials, IMFINZI was administered at a dose of 10 mg/kg every 2 weeks or 20 mg/kg every 4 weeks.1
IMFINZI was evaluated in the PACIFIC clinical trial regimen and demonstrated statistically significant and clinically meaningful improvements for patients with locally advanced, stage III unresectable NSCLC vs placebo.1–2
*Occurring in ≥10% of patients in either treatment arm. Two patients randomised to placebo received at least one dose of IMFINZI and were considered part of the IMFINZI arm for safety reporting;3 † Pneumonitis and radiation pneumonitis were assessed by investigators, with subsequent review and adjudication by the study sponsor.
AE, adverse event; ITT, intention to treat; PD-L1, programmed death-ligand 1; SmPC, Summary of Product Characteristics.
1. Adapted from Antonia SJ, et al. N Engl J Med 2018;379:2342−2350 (Supplementary Appendix); 2. IMFINZI (durvalumab). Summary of Product Characteristics.
https://www.medicines.org.uk/emc/product/9495 (accessed February 2025) - UK; 3. Antonia S, et al. N Engl J Med 2017;377(20):1919–1929 (supplementary appendix).
Imfinzi 50 mg/mL concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (emc)
Imfinzi 50 mg/mL concentrate for solution for infusion - Summary of Product Characteristics (SmPC) by AstraZeneca UK Limited
For an exhaustive list of AEs and warnings, please refer to the Summary of Product Characteristics2
Immune-mediated pneumonitis occurred in 9.9% (47/475) patients in the IMFINZI arm and 6.0% (14/234) of patients in the placebo group, including Grade 3 in 1.9% (9/475) of patients on IMFINZI and 2.6 (6/234) of patients in the placebo group, and Grade 5 in 0.8% patients on IMFINZI and 1.3% (3/234) of patients on placebo.1,2
Grade 5 AEs of any cause occurred in 4.4% (21/475) of patients on IMFINZI vs 6.0% (14/234) in patients on placebo.1
Overall, the safety profile1,2 of IMFINZI in the PD-L1 ≥1% subgroup was consistent with that of the ITT population.1,2 Treatment with IMFINZI resulted in no clinically meaningful difference in patient-reported key lung cancer symptom scores (as measured by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer Module 13 [EORTC QLQ-LC13]) compared with placebo, as assessed by a difference of ≥10 points.1,2
The table below shows an overview of immune-mediated adverse events (imAEs) reported in ≥ 1% of patients in either treatment group, in the as-treated study population of those taking IMFINZI vs the placebo.1
*Composite terms; † Of the 51 patients who experienced immune-mediated pneumonitis while on IMFINZI, ~53% recovered;2 ‡ Grade 5 imAEs with pneumonitis occurred in four patients (0.8%) receiving IMFINZI and three patients (1.3%) receiving placebo.3
AE, adverse event; imAE, immune-mediated adverse event; ITT, intention to treat; SmPC, Summary of Product Characteristics.
1. Antonia S, et al. N Engl J Med 2017;377(20):1919–1929 [Supplementary appendix]; 2. IMFINZI (durvalumab). Summary of Product Characteristics. https://www.medicines.org.uk/emc/product/9495 (accessed January 2025); 3. Antonia S, et al. N Engl J Med 2017;377(20):1919–1929.
The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age have not been established.1,2
Dose adjustment is not required for elderly patients (≥ 65 years of age).1,2 Due to limited data, no dose adjustment of IMFINZI is recommended in patients with mild or moderate renal impairment, as well as those with severe hepatic impairment. Data from patients with severe renal impairment are too limited to draw conclusions on this population.1,2
AE, adverse event; cCRT, concurrent chemoradiotherapy; CRT, chemoradiotherapy; ECOG PS, Eastern Cooperative Oncology Group performance status; EORTC QLQ-LC13, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer Module 13; GI, gastrointestinal; ImAE, immune-mediated adverse event; ITT, intention to treat; KEE, key external expert; MDT, multidisciplinary team; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; SmPC, Summary of Product Characteristics; URTI, upper respiratory tract infection.
GB-66551 | DOP: April 2025
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling 0800 783 0033.
This website was created for UK HCPs and has been designed to provide information to educate, empower and enable them in the great work they are doing for patients across a range of therapy areas. This website is intended for doctors, nurses, and pharmacists in the UK. Other UK residents please visit astrazeneca.co.uk.
GB-74216| DOP : February 2026
