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A standard of care (SoC) for unresectable stage III non-small cell lung cancer (NSCLC) is concurrent chemoradiotherapy (cCRT), followed by the option of IMFINZI for fit (WHO PS 0–1) patients with PD-L1 ≥1%.2
IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.3
Patients with locally advanced NSCLC should be evaluated for treatment based on the tumour expression of PD-L1 confirmed by a validated test before initiation of treatment.3
For full information on dosing and administration, refer to the IMFINZI SmPC.
The recommended IMFINZI(durvalumab) dosage for locally advanced NSCLC is 10 mg/kg every 2 weeks (Q2W) or 1500 mg every 4 weeks (Q4W).3 This applies until there is disease progression, unacceptable toxicity, or up to a maximum of 12 months duration.3
Patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to IMFINZI 10 mg/kg every 2 weeks or 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg.3 There are no anticipated clinically meaningful differences in efficacy and safety for both weight-based (Q2W) and fixed-dose (Q4W) treatment options.3
Implementing cCRT followed by IMFINZI as part of the PACIFIC regimen can help patients achieve sustained overall survival (OS) plus PFS benefit vs placebo. (studied approximately for 5 years)1
The most common adverse reactions with Imfinzi monotherapy were cough/productive cough, diarrhoea, rash, pyrexia, upper respiratory tract infections, abdominal pain, pruritus, and hypothyroidism.3
cCRT, concurrent chemoradiotherapy; CRT, chemoradiotherapy; CT, chemotherapy; IHC, immunohistochemistry; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; RT, radiotherapy; SoC, standard of care.
1. Spigel D, et al. J Clin Oncol 2022;40:1301–1311; 2. The Royal College of Radiologists. Radiotherapy for lung cancer - RCR consensus statements 2020. https://www.rcr.ac.uk/our-services/all-our-publications/clinical-oncology-publications/radiotherapy-for-lung-cancer-rcr-consensus-statements/ (accessed January 2025); 3. IMFINZI (durvalumab). Summary of Product Characteristics. December 2024. https://www.medicines.org.uk/emc/product/9495 (accessed January 2025) - UK; 4. Antonia S, et al. N Engl J Med 2017;377(20):1919–1929; 5. Antonia S, et al. N Engl J Med 2017;377(20):1919–1929 (Study Protocol).
*Please refer to individual products' summary of product characteristics for full information.
| Adverse reactions | Severitya | Treatment Modifications |
|---|---|---|
| Immune-mediated pneumonitis/ interstitial lung disease | ||
| Grade 2 | Withhold dose | |
| Grade 3 or 4 | Permanently discontinue | |
| Immune-mediated hepatitis | ||
| ALT or AST > 3 - ≤ 5 x ULN or total bilirubin > 1.5 - ≤ 3 x ULN | Withhold dose | |
| ALT or AST > 5 - ≤ 10 x ULN | Withhold IMFINZI and permanently discontinue tremelimumab (where appropriate) | |
| Concurrent ALT or AST > 3 x ULN and total bilirubin > 2 x ULNb | Permanently discontinue | |
| ALT or AST > 10 x ULN or total bilirubin > 3 x ULN | ||
| Immune-mediated hepatitis in HCC (or secondary tumour involvement of the liver with abnormal baseline values)c | ||
| ALT or AST > 2.5 - ≤ 5 x BLV and ≤ 20 x ULN | Withhold dose | |
| ALT or AST > 5 - 7 x BLV and ≤ 20 x ULN or concurrent ALT or AST 2.5 - 5 x BLV and ≤ 20 x ULN and total bilirubin > 1.5 - < 2 x ULNb | Withhold IMFINZI and permanently discontinue tremelimumab (where appropriate) | |
| ALT or AST > 7 x BLV or > 20 ULN whichever occurs first or bilirubin > 3 X ULN | Permanently discontinue | |
| Immune-mediated colitis or diarrhoea | ||
| Grade 2 | Withhold dose | |
| Grade 3 for IMFINZI monotherapy | Withhold dose | |
| Grade 3 for IMFINZI + tremelimumab | Permanently discontinue tremelimumabe | |
| Grade 4 | Permanently discontinue | |
| Intestinal perforationd | Any grade | Permanently discontinue |
| Immune-mediated hyperthyroidism, thyroiditis | Grade 2-4 | Withhold dose until clinically stable |
| Immune-mediated hypothyroidism | Grade 2-4 | No changes |
| Immune-mediated adrenal insufficiency or hypophysitis/hypopituitarism | Grade 2-4 | Withhold dose until clinically stable |
| Immune-mediated type 1 diabetes mellitus | Grade 2-4 | No changes |
| Immune-mediated nephritis | ||
| Grade 2 with serum creatinine > 1.5 - 3 x (ULN or baseline) | Withhold dose | |
| Grade 3 with serum creatinine > 3 x baseline or > 3-6 x ULN; Grade 4 with serum creatinine > 6 x ULN | Permanently discontinue | |
Immune-mediated rash or dermatitis
(including pemphigoid) | ||
| Grade 2 for > 1 week | Withhold dose | |
| Grade 3 | ||
| Grade 4 | Permanently discontinue | |
| Immune-mediated myocarditis | Grade 2-4 | Permanently discontinue |
Immune-mediated myositis
/polymyositis | ||
| Grade 2 or 3 | Withhold dosef | |
| Grade 4 | Permanently discontinue | |
| Infusion-related reactions | ||
| Grade 1 or 2 | Interrupt or slow the rate of infusion | |
| Grade 3 or 4 | Permanently discontinue | |
| Infection | Grade 3 or 4 | Withhold dose until clinically stable |
| Immune-mediated myasthenia gravis | Grade 2-4 | Permanently discontinue |
| Immune-mediated Myelitis transverse | Any Grade | Permanently discontinue |
| Immune-mediated meningitis | ||
| Grade 2 | Withhold dose | |
| Grade 3 or 4 | Permanently discontinue | |
| Immune-mediated encephalitis | Grade 2-4 | Permanently discontinue |
| Immune-mediated Guillain-Barré syndrome | Grade 2-4 | Permanently discontinue |
| Other immune-mediated adverse reactionsg | ||
| Grade 2 or 3 | Withhold dose | |
| Grade 4 | Permanently discontinue | |
| Pure red cell aplasia (PRCA)h | Any Grade | Permanently discontinue |
a Common Terminology Criteria for Adverse Events, version 4.03. ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal; BLV: baseline value.
b For patients with alternative cause follow the recommendations for AST or ALT increases without concurrent bilirubin elevations.
c If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue durvalumab based on recommendations for hepatitis with no liver involvement.
d Adverse drug reaction is only associated with IMFINZI in combination with tremelimumab.
e Permanently discontinue trememlimumab for Grade 3; however, treatment with durvalumab can be resumed once event has resolved.
f Permanently discontinue IMFINZI if adverse reaction does not resolve to ≤ Grade 1 within 30 days or if there are signs of respiratory insufficiency.
g Includes immune thrombocytopenia, pancreatitis, immune-mediated arthritis, uveitis and cystitis noninfective.
h Adverse drug reaction is only associated when olaparib maintenance treatment is used in combination with IMFINZI, following treatment with IMFINZI in combination with platinum-based chemotherapy.
Administer the infusion solution intravenously over 1 hour through an intravenous line containing a sterile, low‑protein binding 0.2 or 0.22 micron in‑line filter.3
Do not co‑administer other medicinal products through the same infusion line.3
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.3
IMFINZI infusion time spans one hour as the infusion solution is administered intravenously through an IV line equipped with a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.3
It is important that no co-administration of other drugs through the same infusion line takes place.3 No premedication is required, however if a grade 1 or 2 infusion-related reaction occurs, interrupting or lengthening the IMFINZI infusion time may be required.3
Pre-medication may also be considered for prophylaxis of subsequent infusion reactions (e.g. with corticosteroids).3
Paediatric population
The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age have not been established. No data are available.3
Elderly
No dose adjustment is required for elderly patients (≥ 65 years of age). For more information, please see section 5.1 of the IMFINZI Summary of Product Characteristics.3
Renal impairment
No dose adjustment of IMFINZI is recommended in patients with mild or moderate renal impairment. Data from patients with severe renal impairment are too limited to draw conclusions on this population. For more information, please see section 5.2 of the IMFINZI Summary of Product Characteristics.3
Hepatic impairment
Data from patients with severe hepatic impairment are limited. Due to minor involvement of hepatic processes in the clearance of durvalumab no dose adjustment of IMFINZI is recommended for patients with hepatic impairment as no difference in exposure is expected. For more information, please see section 5.2 of the IMFINZI Summary of Product Characteristics.3 For special warnings and precautions, please see section 4.4 of SmPC for full list.
Patients with pre-existing autoimmune disease
In patients with pre-existing autoimmune disease (AID), data from observational studies suggest an increased risk of immune-related adverse reactions following immune-checkpoint inhibitor therapy as compared with patients without pre-existing AID. In addition, flares of the underlying AID were frequent, but the majority were mild and manageable.3
AND
Patients excluded from clinical trials
Patients with the following were excluded from clinical trials: a baseline ECOG performance score ≥ 2; active or prior documented autoimmune disease within 2 years of initiation of the study; a history of immunodeficiency; a history of severe immune-mediated adverse reactions; medical conditions that required systemic immunosuppression, except physiological dose of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent); uncontrolled intercurrent illnesses; active tuberculosis or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine within 30 days before or after the start of IMFINZI. In the absence of data, durvalumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.3
The safety of concurrent prophylactic cranial irradiation (PCI) with IMFINZI in patients with ES-SCLC is unknown.3
IMFINZI is supplied as single-use vials, available in two dosages: either 120 mg/2.4 mL (50 mg/mL) or 500 mg/10 mL (50 mg/mL).3
Inside is a clear-to-opalescent, colourless-to-slightly yellow solution in a type 1 glass vial with an elastomeric stopper. The 2.4 ml vial has gray flip-off aluminium seal and the 10 ml vial has a white flip-off aluminium seal.3
The drug product must be visually inspected, and the vial must be discarded if the solution is cloudy, discoloured, or visible particles are observed prior to administration.3
Shelf life: 3 years
Store in a refrigerator (2 ° C – 8 ° C).3
Do not freeze.3
Store in the original package in order to protect from light.3
Chemical and physical in-use stability has been demonstrated for up to 30 days at 2 ° C to 8 ° C and for up to 24 hours at room temperature (up to 25 ° C) from the time of preparation.3
The prepared solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ° C to 8 ° C or 12 hours at room temperature (up to 25 ° C), unless dilution has taken place in controlled and validated aseptic conditions.3
IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.3
ALT, alanine aminotransferase; AST, aspartate aminotransferase; cCRT, concurrent chemoradiotherapy; CT, chemotherapy; DRESS, Drug Rash with Eosinophilia and Systemic Symptoms; imAEs, immune-mediated adverse events; NSCLC, non-small cell lung cancer; PD-L1, programmed death ligand 1; RT, radiotherapy; SoC, standard of care; SJS, Stevens-Johnson Syndrome; TEN, toxic epidermal necrolysis; ULN, upper limit of normal.
GB-66554 | 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
