Summary
IMFINZI® 1L SoC in ES-SCLC with CASPIAN 3-year OS-data1-7
Efficacy
- 3-year OS benefit of 17.6 % vs 5.8 % with IMFINZI® + EP vs EP alone3
- 29 % reduction in mortality risk with IMFINZI® + EP vs EP alone, also after 3 years of follow-up3
Quality of life
- Quality of life preserved and longer symptom control in 2 years, including cognitive function4
User friendly
- Only IO approved in combination with etoposide and carboplatin or cisplatin
- Maintenance dosage every 4 weeks5
- Save valuable time for you and your patients through a once a month administration
Study design
- The CASPIAN study design is close to clinical practice5,6
- PCI permitted in the control arm
- Patients with untreated asymptomatic or treated symptomatic CNS metastases were included
Status: July 2023
CNS: central nervous system; EP: etoposide + platinum; ES-SCLC: extensive-stage small cell lung cancer; IO: immunotherapy; OS: overall survival; PCI: prophylactic cranial irradiation; SoC: standard of care.
# to date (status: November 2023) and approved in Switzerland
Study design
The CASPIAN study design – close to clinical practice5,6,§
§ A comprehensive, randomised, open-label, multi-centre phase III study for IMFINZI® + EP vs EP alone as first-line treatment in patients with ES-SCLC5,6
* IMFINZI® 1500 mg + carboplatin (AUC 5 to 6 mg/mL/min) or cisplatin (75–80 mg m ) on Day 1 and etoposide (80–100 mg/m2) i.v. on Days 1, 2 and 3 of each 21-day cycle for a maximum of 4 cycles, followed by IMFINZI 1500 mg every 4 weeks until disease progression or unacceptable toxicity.5,6
† Carboplatin (AUC 5 to 6 mg/mL/min) or cisplatin (75–80 mg/m2) on Day 1 and etoposide (80–100 mg/m2) i.v. on Days 1, 2 and 3 of each 21-day cycle for 4-6 cycles.5,6
AUC: area under the curve; EP: etoposide + platinum; ES-SCLC: extensive-stage small cell lung cancer; PCI: prophylactic cranial irradiation; Q3W: every 3 weeks; Q4W: every 4 weeks
† 78 % of patients were given carboplatin and 25 % were given cisplatin in both treatment arms.
* Patients with confirmed brain metastases had to receive treatment and be stable for at least 1 month on steroids and anticonvulsants before receiving study treatment.
CNS: central nervous system; PCI: prophylactic cranial irradiation
Results
- OS benefit
- OS in subgroups
- Brain metastases
- Without progression
After 3 years - 3× more patients alive with IMFINZI® + EP vs EP alone
Adapted according to Paz-Ares et al., 2022.3
CI: confidence interval; EP: etoposide + platinum; HR: hazard ratio; OS: overall survival
Safety
- Profile of adverse reactions6
- Immune-mediated profile of adverse reactions5,7
The incidence of grade 3/4 adverse drug reactions (ADRs) were similar for IMFINZI® + EP and EP alone (62 %)
Immune-mediated ADRs were observed in 20% of patients on IMFINZI® + EP and in 3% of patients on EP, with the majority exhibiting grade 1 or 2 ADRs which were generally manageable.
ADR: adverse drug reaction; EP: etoposide + platinum-based chemotherapy (carboplatin or cisplatin)
Treatment and dosing
Simple therapy with just ONE administration per month in the maintenance phase
IMFINZI® + EP Q3W, followed by only one administration of IMFINZI® per month5
Note: The dosages follow the protocol for the CASPIAN study.
Please also note the relevant Information for Healthcare Professionals.5
IMFINZI® is SL-listed and therefore the utilisation does not require an additional “Kostengutsprache” (engl. Confirmation of coverage).
More information can be found on the website www.spezialitaetenliste.ch
# Administer IMFINZ® on the same day before chemotherapy. Please also refer to the Information for Healthcare Professionals for etoposide and carboplatin or cisplatin for information on the dosage.5
§ The dosage must be adjusted to body weight in patients weighing 30 kg or less, equivalent to 20 mg/kg IMFINZI® in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as a monotherapy until body weight increases to above 30 kg.5
EP: etoposide + platinum; Q3W: every 3 weeks.
◊ List of specialities. www.spezialitaetenliste.ch.
Real-World Evidence
Durvalumab confirmed as standard in ES-SCLC
The phase III CASPIAN trial has made durvalumab a standard of care for first-line treatment of advanced small cell lung cancer (SCLC) (extensive disease; ES-SCLC). Over 3 years, durvalumab plus cis- or carboplatin and etoposide (EP) reduced the risk of death by 29% compared to EP alone.3 The Spanish phase IIIb study CANTABRICO now confirms the efficacy and safety of durvalumab plus EP under real-world conditions.9
The results of the phase IIIb CANTABRICO study demonstrate that ES-SCLC therapy with durvalumab plus EP is effective and safe in a broad group of patients, even under real-world conditions.9 Both the PFS and the safety profile were similar to the phase III CASPIAN study. The 6-month PFS was even 5% higher in the overall CANTABRICO population than in CASPIAN.7,9 These results confirm the standard of care of durvalumab plus EP for first-line ES-SCLC patients.9 In addition to the data shown, the CANTABRICO study is also investigating immunological and biological characteristics of ES-SCLC patients before therapy, between induction and maintenance therapy, and at the time of progression. These biomarker analyses may provide future insights into the molecular genetic disease process of ES-SCLC.9
Guidelines
IMFINZI® in ES-SCLC is recommended by ESMO Guidelines2
In the ES-SCLC, therapy with durvalumab in combination with platinum and etoposide should be offered to all eligible patients with ECOG status 0-1 who have not received prior chemotherapy.2
References
- NCCN Guidelines SCLC, online available: https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf (last access: 12.10.2023).
- ESMO Guidelines SCLC, online available: https://www.esmo.org/guidelines/guidelines-by-topic/esmo-clinical-practice-guidelines-lung-and-chest-tumours/small-cell-lung-cancer (last access: 02.02.2024).
- Paz-Ares L, et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN. ESMO Open. 2022; 7 (2): 100408.
- Goldman JW, et al. Patient-reported outcomes with firstline durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study. Lung Cancer. 2020 Nov; 149: 46–52.
- IMFINZI® Information for Healthcare Professionals. www.swissmedicinfo.ch.
- Paz-Ares L, et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in firstline treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase 3 trial. Lancet. 2019; 394(10212): 1929–1939.
- Goldman JW, et al. Durvalumab, with or without tremelimumab, plus platinum–etoposide versus platinum–etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021; 22(1): 51–65.
- Chen Y, et al. Impact of Brain Metastases on Treatment Patterns and Outcomes With First-Line Durvalumab Plus Platinum-Etoposide in Extensive-Stage SCLC (CASPIAN): A Brief Report. JTO Clin Res Rep 2022; 3(6): 100330.
- Isla D, et al. Phase IIIb study of durvalumab plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CANTABRICO): preliminary efficacy results. Ann Oncol. 2022; 33(S7):S1247-S1248.
Professionals can request the mentioned references from AstraZeneca AG.