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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 (durvalumab) in the CASPIAN study demonstrated that patients experienced similar rates of adverse reactions with IMFINZI + EP vs EP alone.3 In the CASPIAN clinical trial, IMFINZI was administered at a dose of 1,500 mg intravenously every 3 weeks during the chemotherapy phase (i.e. with EP for 4 cycles). This was followed by maintenance IMFINZI 1,500 mg IV every 4 weeks until disease progression or unacceptable toxicity. The chemotherapy backbone consisted of etoposide 80–100 mg/m² on Days 1–3, combined with either cisplatin 75–80 mg/m² or carboplatin AUC 5–6 mg/ml/min on Day 1, administered every 3 weeks for 4 cycles.3
Patients with a body weight of 30 kg or less must receive weight-based dosing of IMFINZI at 20 mg/kg, in combination with chemotherapy dose every 3 weeks, followed by 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg.4
IMFINZI was evaluated in the CASPIAN clinical trial regimen and demonstrated clinical benefit in the primary endpoint of overall survival for patients with ES-SCLC.4
In the EP alone arm, the most common adverse reaction (≥20%) were neutropenia, anaemia, nausea, alopecia and thrombocytopenia. In the IMFINZI + etoposide arm the most common were neutropenia, anaemia, nausea and alopecia. The most common immune-mediated adverse reactions were hypothyroid events and hyperthyroid events, most of which were Grade 1 or 2 in severity. Pneumonia of any grade occurred in 4% of patients treated with IMFINZI + EP and 7% of those treated with EP alone3
| All grades (%) | Grades 3–4 (%) | |||
|---|---|---|---|---|
| IMFINZI + EP (n=265) | EP (n=266) | IMFINZI + EP (n=265) | EP (n=266) | |
| Neutropenia | 42% | 47% | 24% | 33% |
| Anaemia | 38% | 48% | 9% | 18% |
| Nausea | 34% | 34% | <1% | 2% |
| Alopecia | 32% | 34% | 1% | 1% |
| Decreased appetite | 18% | 18% | 1% | 1% |
| Constipation | 17% | 19% | 1% | 0% |
| Thrombocytopenia | 16% | 20% | 6% | 9% |
| Fatigue | 19% | 17% | 2% | 1% |
| Asthenia | 16% | 15% | 2% | 1% |
| Vomiting | 15% | 16% | 0% | 1% |
| Leukopenia | 15% | 12% | 6% | 5% |
| Cough | 13% | 7% | 1% | 0% |
| Dyspnoea | 12% | 11% | 2% | 2% |
| Diarrhoea | 11% | 11% | 2% | 1% |
| Neutrophil count decreased | 9% | 11% | 6% | 6% |
| Hyponatraemia | 10% | 5% | 4% | 3% |
| Hyperthyroidism | 10% | <1% | 0% | 0% |
Immune-mediated adverse reactions of any grade, regardless of cause, were reported in 20% of patients treated with IMFINZI + EP and 3% of those treated with EP alone. Grade 3 or 4 immune-mediated adverse reactions were 5% and <1%, respectively. Discontinuation rates due to adverse reactions were similar for IMFINZI + EP (10%) vs EP alone (9%).3
Immune-mediated adverse reactions are special warnings in the IMFINZI Summary of Product Characteristics (SmPC). For a full list of AEs and warnings, please refer to the IMFINZI Summary of Product Characteristics.4
For full information on the safety profile and considerations, please refer to the IMFINZI Summary of Product Characteristics.4
The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age have not been established.4
Dose adjustment is not required for elderly patients (≥65 years of age). 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. No dose adjustment of IMFINZI is recommended for patients with hepatic impairment as no difference in exposure is expected. Data from patients with severe hepatic impairment are too limited to draw conclusions on this population.
Learn more about the dosing details in the CASPIAN Regimen
Take a closer look at how IMFINZI works within the CASPIAN Regimen
Discover more about the CASPIAN study design and efficacy outcomes
GB-68887 | DOP: August 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
