IMFINZI + EP is the ONLY IO COMBINATION with 3-year OS DATA vs EP alone.2,3*
*18% of patients alive with IMFINZI + EP vs 6% with EP alone at 3 years (HR 0.71; 95% CI 0.60–0.86; nominal P=0.0003; 39.4 months median follow-up; planned exploratory OS analysis).3 The primary endpoint of OS was met at the planned interim analysis (14.2 months median follow-up) mOS 13.0 months with IMFINZI + EP vs 10.3 months with EP alone (HR 0.73; 95% CI 0.59–0.91; P=0.0047).4
CASPIAN clinical outcomes
Click each section below to discover more
In 1L ES-SCLC, IMFINZI + EP is the only IO combination with 3-year OS data vs EP alone2,3†
†3-year planned exploratory analysis:
Overall survival (intention-to-treat; 39.4 months median follow-up)3
Adapted from Paz-Arez, et al. 2022.3
CASPIAN study primary endpoint of OS was met at the planned interim analysis (14.2 months median follow-up) mOS 13.0 months with IMFINZI + EP vs 10.3 months with EP alone (HR 0.73; 95% CI 0.59–0.91; P=0.0047).2,4 3-year planned exploratory OS analysis was conducted at ~3 years after the last patient was randomised and was not tested for statistical significance; mOS 12.9 months with IMFINZI + EP vs 10.5 months with EP alone (HR 0.71 95% CI 0.60-0.86, nominal P=0.0003).3
In 1L ES-SCLC, OS benefit consistently favoured IMFINZI + EP across
prespecified patient subgroups3
Subgroup analysis of overall survival3
Adapted from Paz-Ares et al. 2022.3
Size of circle is proportional to the number of events across both treatment groups. OS subgroup analysis was not powered to show differences between or within individual subgroups, and was not tested for statistical significance.3,4
‡Time to deterioration in physical functioning with IMFINZI + EP 8.5 months vs 6.5 months with EP alone (nominal P=0.0276); time to deterioration in cognitive functioning with IMFINZI + EP 8.4 months vs 6.0 months with EP alone (nominal P<0.0001).5 Results should be interpreted in the context of an open-label study.5
Time to deterioration in select symptoms5
Adapted from Goldman JW et al. 2020.5
Baseline QLQ-C30 data were available for 245 patients in each arm, and baseline QLQ-LC13 data were available for 244 patients in the IMFINZI + EP arm and 245 patients in the EP only arm. Time to deterioration was defined as the time from randomisation until the first clinically meaningful deterioration confirmed at a subsequent visit or death.7 Time to deterioration in global health status/QoL (QLQ-C30) was numerically longer with IMFINZI + EP 8.4 months vs 7.2 months with EP alone (nominal P=0.1166 not significant).5 Results should be interpreted in the context of an open-label study.5
Time to deterioration in select symptoms5
Adapted from Goldman JW et al. 2020.5
The analysis population includes patients with baseline scores ≥10. An HR <1.0 indicates longer TTD with IMFINZI + EP vs EP alone.5 Time to deterioration in global health status/QOL (QLQ-C30) was numerically longer with IMFINZI + EP 8.4 months vs 7.2 months with EP alone (nominal P=0.1166 not significant).5
- Serious AEs were reported in 85/265 (32%) IMFINZI + EP patients vs 97/266 (36%) EP patients8
- Most common Grade 3 or worse AEs were neutropenia (24% IMFINZI + EP patients vs 33% EP patients) and anaemia (9% IMFINZI + EP patients vs 18% EP patients)8
Immune-related adverse events (irAEs)8
- irAEs were reported in 20% IMFINZI + EP patients and 3% EP patients
- Grade 3/4 irAEs occurred in 5% IMFINZI + EP patients and <1% EP patients
- Most common irAEs were hypothyroid/hyperthyroid events, most of which were Grade 1/2 in severity
CASPIAN trial: 3-year OS Update
The efficacy of IMFINZI in combination with etoposide and either carboplatin or cisplatin (EP) in treatment-naive ES-SCLC patients was investigated in CASPIAN, a phase III, randomised, open-label, multicentre, international study.
(Paz-Ares L et al. ESMO Open. 2022;7(2):100408)
The full publication is available in ESMO Open (open access)
The CASPIAN trial was designed to reflect real-world practice4
Q4W maintenance dosing after induction2,4
Patients with a body weight of ≤30 kg must receive weight-based dosing, equivalent to IMFINZI 20 mg/kg in combination with chemotherapy Q3W (21 days) for 4 cycles, followed by 10 mg/kg Q2W as monotherapy unt il weight increases to >30 kg.2
Results from CASPIAN in clinical practice
Dr Narjust Florez
Importance of maintaining functioning in ES-SCLC
Dr Narjust Florez
IMFINZI® (durvalumab) Minimum Product Information 120mg/2.4mL or 500mg/10mL, Concentrated Solution for Infusion in a Single-Dose Vial INDICATIONS: Small cell lung cancer (SCLC): ES-SCLC: IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). DOSAGE AND ADMINISTRATION: ES-SCLC: 1500 mg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 1500 mg every 4 weeks as monotherapy until disease progression or unacceptable toxicity. Patients with a body weight of 30 kg or less must receive weight based dosing, equivalent to IMFINZI 20 mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as monotherapy until weight increases to greater than 30 kg. Administer IMFINZI prior to chemotherapy when given on the same day. Refer to other relevant Product Information when IMFINZI is administered in combination with chemotherapy. IMFINZI is administered as an IV infusion over 60 minutes. IMFINZI should be diluted prior to infusion, see full PI for compatible diluents. No dose reduction or escalation for IMFINZI is recommended. In general, withhold IMFINZI for Grade 2 or 3 adverse reactions. Permanently discontinue IMFINZI for life threatening (Grade 4) adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating corticosteroids. For Grade 4 laboratory abnormalities, discontinuation of IMFINZI should be based on clinical signs/symptoms and clinical judgement. See full PI for recommended treatment modifications and specific management for adverse reactions. IMFINZI has not been studied in patients with severe renal or hepatic impairment. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Immune-mediated adverse reactions (imARs): Immune checkpoint inhibitors, including durvalumab, can cause severe and fatal imARs, which may involve any organ system. Patients should be monitored for signs and symptoms associated with imARs including: immune-mediated pneumonitis/interstitial lung disease, radiation pneumonitis, hepatitis, colitis, immune-mediated endocrinopathies including hypothyroidism/hyperthyroidism/thyroiditis, adrenal insufficiency, type 1 diabetes mellitus, hypophysitis/hypopituitarism, nephritis, dermatological adverse reactions, myocarditis, neurological adverse reactions (meningitis, encephalitis, Guillain-Barre syndrome, transverse myelitis, myasthenia gravis) and other imARs. See full PI for further information on monitoring and management recommendations for imARs. Infusion-related reactions: Monitor patients for signs and symptoms,severe reactions have been reported. Patients with pre-existing auto-immune disease (AID): increased risk of imARs compared with the risk in patients without pre-existing AID. In addition, flares of the underlying AID were frequent, but the majority were mild and manageable. Efficacy in patients with PDL1 expression <1%: efficacy may be different, see full PI. Paediatric use: safety and efficacy not established in patients less than 18 years. Use in pregnancy: Category D. Durvalumab has the potential to impact maintenance of pregnancy and may cause foetal harm. Not recommended during pregnancy; women of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose. Use in lactation: lactating women should be advised not to breastfeed during treatment and for at least 3 months after the last dose. ADVERSE REACTIONS: ES-SCLC (CASPIAN study): Very common (≥10%, any grade): Cough/productive cough, nausea, constipation, vomiting, diarrhoea, hyperthyroidism, alopecia, rash, fatigue/asthenia, decreased appetite. See full PI for other listed adverse reactions including immune-mediated adverse reactions.
IMFINZI Patient Guide
An information booklet for patients being treated with IMFINZI for ES-SCLC
IMFINZI Patient Alert Card
A wallet-sized alert card that should be carried by patients being treated with IMFINZI
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Abbreviations: 1L, first-line; 2L/3L, second line/third line; AE, adverse event; AJCC, American Joint Committee on Cancer; AUC, area under the curve; CI, confidence interval; CNS, central nervous system; ECOG, Eastern Cooperative Oncology Group; EP, etoposide and either carboplatin or cisplatin; ES-SCLC, extensive-stage small cell lung cancer; HR, hazard ratio; IO, immunotherapy; irAE, immune-related adverse event; mOS, median overall survival; NA, not applicable; NS, not significant; ORR, objective response rate; OS, overall survival; PBS, Pharmaceutical Benefits Scheme; PCI, prophylactic cranial irradiation; PFS, progression-free survival; PRO, patient-reported outcome; Q2W, every 2 weeks; Q3W, every 3 weeks; Q4W, every 4 weeks; QLQ-C30, Quality of Life Questionnaire-Core 30; QLQ-LC13, Quality of Life Questionnaire-Lung Cancer 13; QoL, quality of life; R, randomised; RECIST, Response Evaluation Criteria in Solid Tumors; TTD, time to deterioration; uNSCLC, unresectable non-small cell lung cancer; WHO, World Health Organization.
Reference: 1. Pharmaceutical Benefits Scheme. Available at: www.pbs.gov.au. 2. IMFINZI Approved Product Information. 3. Paz-Ares L et al. ESMO Open 2022;7(2):100408. 4. Paz-Ares L et al. Lancet 2019;394(10212):1929–39. 5. Goldman JW et al. Lung Cancer. 2020;149:46–52 (including supplementary data). 6. Bebb DG et al. Pulm Ther 2023;9(3):435–50. 7. Altman DE et al. Oncol Ther 2023;11(2):231–44. 8. Goldman JW et al. Lancet Oncol 2021;22(1):51–65.
IMFINZI® is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com.