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The safety profile of IMFINZI (durvalumab) in the ADRIATIC study was generally consistent with the known safety profile of IMFINZI, with comparable rates of Grade 3/4 adverse events observed between the IMFINZI and placebo arms. Patients with limited-stage small-cell lung cancer (LS-SCLC) whose disease had not progressed following platinum-based chemoradiotherapy (cCRT) were randomised to receive IMFINZI 1,500 mg intravenously every 4 weeks (or 20 mg/kg for patients weighing <30 kg) for up to 24 months, or until disease progression or unacceptable toxicity.1,6
Patients enrolled in ADRIATIC had completed definitive platinum-based cCRT prior to initiating IMFINZI. Depending on local practice and the approved indication, this includes either concurrent chemoradiotherapy (cCRT) or sequential chemoradiotherapy (sCRT), with prophylactic cranial irradiation (PCI) administered where clinically appropriate before IMFINZI initiation.1,6
IMFINZI was evaluated in the ADRIATIC phase III clinical trial and demonstrated statistically significant improvements in both overall survival (OS) and progression-free survival (PFS) versus placebo, in patients with LS-SCLC whose disease had not progressed following platinum-based CRT.1,6
MOST COMMON ADVERSE REACTIONS6
The most common (≥10%) adverse reactions were radiation pneumonitis (22.9%), decreased appetite (16.8%), hypothyroidism (16.0%), cough/productive cough (15.3%), pruritus (13.0%), nausea (12.6%), dizziness (12.2%), fatigue (12.2%), diarrhoea (11.1%), pneumonia (11.1%), pneumonitis (10.7%), rash (10.7%), constipation (10.3%), and hyperthyroidism (10.3%).6
The most common (≥ 2%) Grade 3 or 4 adverse reactions were pneumonitis or radiation pneumonitis (3.1%) and pneumonia (2.7%). Immune-mediated adverse reactions are special warnings for IMFINZI.6
For further information on adverse events (AEs) and their management, please refer to the Imfinzi SmPC.1
| IMFINZI (n=262)† | placebo (n=265) | |||
|---|---|---|---|---|
| Adverse reaction* | All grades (%) | Grade 3 or 4 (%)‡ | All grades (%) | Grade 3 or 4 (%)‡ |
| Radiation pneumonitis | 22.9% | 1.1% | 23.4% | 1.9% |
| Decreased appetite | 16.8% | 0% | 12.8% | 0% |
| Hypothyroidism | 16.0% | 0% | 3.8% | 0% |
| Cough/productive cough | 15.3% | 0% | 12.1% | 0% |
| Pruritus | 13.0% | 0% | 7.2% | 0% |
| Nausea | 12.6% | 0% | 10.9% | 0% |
| Dizziness | 12.2% | 0% | 7.5% | 0% |
| Fatigue | 12.2% | 0.4% | 12.8% | 1.5% |
| Diarrhoea | 11.1% | 1.9% | 8.3% | 0% |
| Pneumonia | 11.1% | 2.7% | 7.5% | 3.4% |
| Pneumonitis | 10.7% | 1.1% | 6.0% | 0.8% |
| Rash | 10.7% | 0.4% | 6.0% | 0% |
| Constipation | 10.3% | 0% | 9.8% | 0% |
| Hyperthyroidism | 10.3% | 0% | 1.5% | 0% |
| Headache | 9.2% | 0.4% | 13.2% | 0% |
| Anaemia | 8.8% | 1.1% | 6.0% | 1.1% |
| Arthralgia | 6.9% | 0% | 10.9% | 0.4% |
| Hyperglycaemia | 4.2% | 1.1% | 3.8% | 0% |
| Hypertension | 3.4% | 1.1% | 1.5% | 0% |
| Lipase increased | 3.1% | 1.9% | 2.6% | 1.5% |
| Amylase increased | 2.7% | 1.1% | 1.1% | 0% |
| Chronic obstructive pulmonary disease | 2.3% | 0.4% | 2.6% | 1.5% |
| Pulmonary embolism | 2.3% | 1.9% | 1.5% | 1.1% |
*The safety population included all patients who received a dose of trial drug or placebo. AEs shown include events of any cause with an onset date after the first dose of IMFINZI or placebo, as well as any AE occurring before the first dose that increased in severity after the first dose, through to 90 days after the last dose or until the start of the first subsequent systemic anticancer therapy (whichever occurred first).6
†One patient who had been randomly assigned to the IMFINZI group received an unlicensed combination and thus is not included in the results. The patient will be included in the respective unlicensed combination group of the safety population.6
‡The numbers and percentages of patients with an AE of a maximum grade of 3 or 4 are shown.6
Immune-mediated adverse events (imAEs) of any grade, regardless of cause, were reported in 32.1% of patients treated with IMFINZI following cCRT and 10.2% of patients treated with placebo.6†
†imAEs were AEs of special interest (excluding infusion-related, hypersensitivity, or anaphylactic reactions) that were consistent with an immune-mediated mechanism and that led to treatment with systemic glucocorticoids, other immunosuppressants, or endocrine therapy.6
imAEs are a special warning and routine monitoring of patients for signs and symptoms is essential.1
ADRIATIC indication: IMFINZI as monotherapy is indicated for the treatment of adults with limited-stage small-cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.1
CASPIAN indication: IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small-cell lung cancer (ES‑SCLC).1
NICE recommends IMFINZI can be used, within its marketing authorisation, as an option to treat limited-stage small-cell lung cancer that has not progressed after platinum-based chemoradiotherapy in adults. IMFINZI can only be used if the company provides it according to the commercial arrangement.²
SMC has accepted IMFINZI for treating adults with LS-SCLC. It is used in patients whose disease has not got worse after platinum-based chemoradiation therapy (chemotherapy and radiotherapy given at the same time).4
Learn more about the dosing details in the ADRIATIC Regimen
Take a closer look at how IMFINZI works within the ADRIATIC Regimen
Discover more about the ADRIATIC study design and efficacy outcomes
AEs, adverse events; CRT, chemoradiotherapy; cCRT, concurrent chemoradiation therapy; ES-SCLC, extensive-stage small-cell lung cancer; IO, immunotherapy; imAEs, immune-mediated adverse events; LS-SCLC, limited-stage small-cell lung cancer SAEs, serious adverse events; sCRT, sequential chemoradiotherapy.
GB-76776 | DOP: September 2026
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
