Welcome to this UK AstraZeneca produced and funded website
This website is intended for UK Healthcare Professionals only.
The website contains both promotional and non-promotional content.
If you are a patient or a carer of a patient prescribed an AstraZeneca product, please visit myazmed.co.uk
For any other UK residents please visit astrazeneca.co.uk
This website is intended for UK Healthcare professionals only. Other UK residents please visit astrazeneca.co.uk
IMFINZI (durvalumab) 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.1
CASPIAN was a randomised, open-label, Phase III, multicentre study in 805 treatment-naïve ES-SCLC patients with WHO/ECOG Performance Status of 0 or 1, body weight >30 kg, suitable to receive a platinum-based chemotherapy regimen as first-line treatment for SCLC, with life expectancy ≥12 weeks, at least one target lesion by RECIST 1.1 and adequate organ and bone marrow function. Patients were 1:1:1 randomly assigned to: IMFINZI + EP; IMFINZI + an unlicensed drug combination + EP; or EP alone. Patients received up to four cycles of EP plus IMFINZI 1,500 mg with or without an unlicensed drug combination 75 mg every 3 weeks followed by maintenance IMFINZI 1,500 mg every 4 weeks in the immunotherapy groups and up to six cycles of EP every 3 weeks plus prophylactic cranial irradiation (investigator’s discretion) in the EP group. The primary endpoint was overall survival in the ITT population.1,4
The CASPIAN study improved OS vs EP alone in first-line ES-SCLC.1
OS
Adapted from Paz-Ares L et al. Lancet 2019.4
* IMFINZI 1,500 mg + either carboplatin (AUC 5 mg/mL/min or 6 mg/mL/min) or cisplatin (75–80 mg/m2) on Day 1 and etoposide (80–100 mg/m2) intravenously on Days 1, 2 and 3 of each 21-day cycle for 4 cycles, followed by IMFINZI 1,500 mg every 4 weeks until disease progression or unacceptable toxicity.4 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.1
† Either carboplatin (AUC 5 mg/mL/min or 6 mg/mL/min) or cisplatin (75–80 mg/m2) on Day 1 and etoposide (80–100 mg/m2) intravenously on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.4
‡ Assessed using investigator assessments according to RECIST v1.1.4
§ 78% received carboplatin and 25% received cisplatin in the IMFINZI + EP arm; 78% received carboplatin and 25% received cisplatin in the EP alone arm.4
¶ Patients with confirmed brain metastases had to be treated and stable off steroids and anticonvulsants for at least 1 month prior to study treatment. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to trial entry.4,7
# 8% of patients who were treated with EP alone received PCI post EP.4
AUC – area under the curve; CNS – central nervous system; CT – computed tomography; EP – etoposide + cisplatin or carboplatin; ES-SCLC – extensive-stage small-cell lung cancer; MRI – magnetic resonance imaging; ORR – objective response rate; OS – overall survival; PCI – prophylactic cranial irradiation; PFS – progression-free survival; PRO – patient-reported outcome; Q3W – once every 3 weeks; Q4W – once every 4 weeks; RECIST – Response Evaluation Criteria in Solid Tumours; WHO – World Health Organization.
Patients were randomly assigned in a 1:1:1 ratio via voice- or web-response to receive IMFINZI + EP, IMFINZI with an unlicensed drug combination combination and EP, or EP alone, stratified by planned platinum type (carboplatin or cisplatin).1,4
IMFINZI + EP significantly extended mOS to 13.0 months (95% CI: 11.5–14.8), compared to 10.3 months (95% CI: 9.3–11.2) in patients receiving EP alone.4
(Median duration of follow-up 14.2 months)
Adapted from Paz-Ares L et al. Lancet 2019.4
* The interim (primary) analysis of overall survival was planned when approximately 318 events had occurred both in the IMFINZI + EP and EP alone arms.4
† OS, the primary endpoint, met statistical significance at the interim analysis in accordance with the CASPIAN trial design (63% maturity). OS was defined as time from randomisation to death from any cause.4
CI – confidence interval; EP – etoposide + cisplatin or carboplatin; ITT – intention-to-treat; mOS – median overall survival; OS – overall survival.
CASPIAN regimen improved OS for patients with ES-SCLC. At the time of the 3-year analysis, mOS was 12.9 months (95% CI: 11.3–14.7) with IMFINZI + EP vs 10.5 months (95% CI: 9.3–11.2) with EP alone (HR 0.71 [95% CI: 0.60–0.86] nominal P=0.0003).5
(Median duration of follow-up 39.4 months)†
Adapted from Paz-Ares L et al. ESMO Open 2022.5
* 3-year analysis of OS was conducted after 469 events had occurred across the IMFINZI + EP and EP alone arms (86% maturity).5
† Landmark OS estimates calculated using the Kaplan–Meier estimator.5
CI – confidence interval; EP – etoposide + cisplatin or carboplatin; ESMO – European Society for Medical Oncology; ES-SCLC – extensive-stage small-cell lung cancer; HR – hazard ratio; IO – immuno-oncology; mOS – median overall survival; OS – overall survival.
In a prespecified exploratory subgroup analysis, the 18-month OS rate was 25% (95% CI: 11.1–41.8) with IMFINZI + EP, compared to 23.3% (95% CI: 9.5–40.7) with EP alone in patients with ES-SCLC.8
Patients with asymptomatic or treated-and-stable brain metastases were eligible for inclusion in the CASPIAN exploratory subgroup analyses.8
Adapted from Chen Y et al. JTO Clin Resp Rep 2022.8
Prespecified analyses of OS and PFS in subgroups with or without brain metastases used unstratified-Cox proportional hazards models.8
CI – confidence interval; EP – etoposide + cisplatin or carboplatin; ES-SCLC – extensive-stage small-cell lung cancer; HR – hazard ratio; OS – overall survival.
Adapted from Chen Y et al. JTO Clin Resp Rep 2022.8
Prespecified analyses of OS and PFS in subgroups with or without brain metastases used unstratified-Cox proportional hazards models.8
CI – confidence interval; EP – etoposide + cisplatin or carboplatin; ES-SCLC – extensive-stage small-cell lung cancer; HR – hazard ratio; OS – overall survival.
OS results in some of the subgroups favoured IMFINZI + EP vs EP alone:*5
* OS subgroup analysis was not powered to show a statistically significant difference between or within individual subgroups.4
AJCC – American Joint Committee on Cancer; CI – confidence interval; CNS – central nervous system; EP – etoposide + cisplatin or carboplatin; HR – hazard ratio; OS – overall survival; WHO – World Health Organization.
In the ongoing open-label, Phase III CASPIAN trial, PFS rate at 12 months was evaluated as a secondary endpoint. At this time, the mPFS was 5.1 months (95% CI: 4.7–6.2) for patients treated with IMFINZI + EP, compared to 5.4 months (95% CI: 4.8–6.2) for those receiving EP alone.9
Adapted from Goldman JW et al. Lancet Oncol 2021 and DOF. REF-217111.9,10
* PFS rate at 12, 18 and 24 months are the estimated proportion of patients alive and progression-free based on the planned follow-up analysis.9,10
† PFS was not formally tested for statistical significance at the planned interim (primary) analysis or the planned follow-up analysis.5,9
CI – confidence interval; EP – etoposide + cisplatin or carboplatin; HR – hazard ratio; OS – overall survival; PFS – progression-free survival.
In a post-hoc analysis of confirmed responses, IMFINZI + EP achieved a higher objective response, compared to EP alone with an odds ratio of 1.56 (95% CI: 1.10–2.22)4
IMFINZI + EP resulted in over 3x as many patients maintaining a response at both 12 and 24 months compared to EP alone.9 ORR and duration of response were not evaluated at the 3-year planned exploratory OS analysis.5
(Post-hoc analysis)*†4
Adapted from Paz-Ares L et al. Lancet 2019.4
Post-hoc analysis (median duration of follow-up 25.1 months)9
Adapted from Goldman JW et al. Lancet Oncol 2021.9
* Confirmed objective response and duration of confirmed objective response were analysed post-hoc. For confirmed responses, a confirmatory scan was required no sooner than 4 weeks after the initial response or partial response.4
† Unconfirmed ORR was a secondary endpoint, with the confirmed responses (68% vs 58%) further supporting the unconfirmed responses (79% vs 70%) seen during the trial.4
CI – confidence interval; EP – etoposide + cisplatin or carboplatin; ORR – objective response rate; OS – overall survival.
Symptoms were assessed using the EORTC QLQ-C30 and QLQ-LC13.*11 Time to deterioration was defined as the time from randomisation until the first clinically meaningful deterioration confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration.11
Adapted from Goldman JW et al. Lung Cancer 2020.11
* EORTC QLQ-C30 is an integrated questionnaire for assessing HRQoL of cancer patients participating in clinical trials using a global health status/quality of life scale, 5 functional scales, 3 symptom scales and 6 single items. EORTC QLQ-LC13 is a supplementary system designed to evaluate symptoms and side effects specifically in patients with lung cancer when used in conjunction with the QLQ-C30.12
CI – confidence interval; EORTC – European Organisation for Research and Treatment of Cancer; EP – etoposide + cisplatin or carboplatin; HR – hazard ratio; HRQoL – health-related quality of life; QLQ – Quality of Life Questionnaire.
Patients receiving IMFINZI + EP experienced a longer median TTD than those receiving EP alone across global health status/QoL, all functioning domains, and all symptom scales of the QLQ-C30 and QLQ-LC1311
Adapted from Goldman JW et al. Lung Cancer 2020.11
EP – etoposide + cisplatin or carboplatin; QoL – quality of life; TTD – time to deterioration.
A single-centre, real-world, retrospective study compared the efficacy and safety of atezolizumab and IMFINZI in combination with chemotherapy in the first-line setting of ES-SCLC.13
IMFINZI and atezolizumab have not been compared in head-to-head trials.
Adapted from Vince M et al. Lung Cancer 2024.13
AJCC – American Joint Committee on Cancer; ES-SCLC – extensive-stage small cell lung cancer; ICI – immune checkpoint inhibitor; OS – overall survival; PFS – progression-free survival; SCLC – small-cell lung cancer.
Adapted from Vince M et al. Lung Cancer 2024.13
* Considering IMFINZI as the reference.13
CI – confidence interval; HR – hazard ratio; ICI – immune checkpoint inhibitors; mOS – median overall survival; mPFS – median progression-free survival; OS – overall survival.
| IMFINZI (n=55) | Atezolizumab (n=46) | p-value | |
|---|---|---|---|
| Any irAEs, n (%) | 18 (32.7)* | 22 (47.8) | 0.157 |
| Type, n (%) | |||
| Colitis | 2 (3.6) | 6 (13) | 0.083 |
| Pneumonitis | 4 (7.3) | 5 (10.9) | 0.53 |
| Skin/Rash | 7 (12.7) | 5 (10.9) | 0.775 |
| Other | 1 (1.8) | 3 (6.5) | 0.23 |
| Hepatitis | 1 (1.8) | 3 (6.5) | 0.23 |
Adapted from Vince M et al. Lung Cancer 2024.13
Immune-mediated adverse reactions, including immune-mediated hyperthyroidism and hypothyroidism, colitis, pneumonitis, rash and hepatitis are special warnings in the IMFINZI SmPC. Please refer to the IMFINZI SmPC for a full list of adverse events and their management.1
* Follow-up of irAE management for one patient not available.13
irAE – immune-related adverse event.
Get to know the CASPIAN safety profile
Learn more about the dosing details in the CASPIAN Regimen
Take a closer look at how IMFINZI works within the CASPIAN Regimen
GB-68886 | 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
