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IMFINZI durvalumab

IMFINZI® IN UR ST. III NSCLC1

The only approved immunotherapy
for stage III unresectable NSCLC after CRT1

Summary

Stage III NSCLC after concurrent and sequential CRT1

Efficacy

Efficacy

  • Sustained 5-year OS and PFS benefit2
  • 28 % reduction in risk of mortality2
  • Median OS 47.5 months vs 29.1 months2,‡
SoC

Standard of Care

  • Only approved IO in UR ST III NSCLC
  • Independent of PD-L1 status

Status: July 2023

‡ in comparison to placebo.

CRT: chemoradiotherapy; IO: immunotherapy; NSCLC: non-small cell lung cancer; OS: overall survival; PD-L1: programmed death ligand 1; PFS: progression-free survival; UR ST III NSCLC: unresectable stage III non-small cell lung cancer.

Study design

PACIFIC: Core phase III study with IMFINZI®1,3

Patients with locally advanced NSCLC (stage III)* ECOG performance status 0 – 1

CASPAIN study design graphics

* based on the IASLC Staging Manual in Thoracic Oncology, Version 7.

‡ Patients with 12 months of therapeutic benefit and progression after completion of therapy can be treated with IMFINZI® again.

ECOG: Eastern Cooperative Oncology Group; i.v.: intravenous; CRT: chemoradiotherapy; NSCLC: non-small cell lung cancer; R: randomisation

Results

  • OS benefit
  • OS in subgroups
  • PFS
  • PFS in subgroups

Sustained 5-year survival benefit with IMFINZI®2

OS benefit graph

Adapted according to Spigel et al., 2022.2
CI: confidence interval; HR: hazard ratio; OS: Overall survival

Safety

  • Profile of adverse reactions1,3
  • Convincing safety profile in relation to immune-mediated adverse reactions1,3

Therapy discontinued due to ADRs: 15.4 % with IMFINZI® vs 9.8 % with placebo3

Table - Therapy discontinued due to ADRs

* The term pneumonitis includes pneumonitis and radiation pneumonitis.3
ADR: adverse drug reaction

Treatment and dosing

Holistic treatment concept with IMFINZI®1

1x monthly maintenance therapy - every 4 weeksTreatment based on body weight

In patients with a body weight of 30 kg or less, weight-based dosing is required, corresponding to IMFINZI 20 mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as monotherapy until a body weight of more than 30 kg is reached. This dosing recommendation is supported by population pharmacokinetic simulations.1

* Patients weighing 30 kg or less must be given a dose based on body weight, equivalent to 10 mg/kg IMFINZI® every 2 weeks or 20 mg/kg every 4 weeks as a monotherapy until body weight has increased to above 30 kg.

IMFINZI® is approved for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed after definitive platinum-based chemoradiotherapy.1

Breadth of Evidence2-8

IMFINZI® - Standard of care for stage III UR NSCLC patients9,10,*

The only approved and reimbursed immunotherapy for stage III unresectable NSCLC after CRT1,11

Extensive breadth of clinical evidence with long-term Follow-Up (PACIFIC, PACIFIC-R, PACIFIC-6, PACIFIC-IIIA-N2)2-8

  • PACIFIC: Sustained 5-year OS and PFS benefit with 28% reduction in risk of mortality and 18 months longer median overall survival versus placebo2
  • PACIFIC-R: Real-world confirmatory evidence showing an improvement in PFS and OS comparable to the PACIFIC trial2,5
  • PACIFIC 6: Good tolerability and encouraging efficacy of IMFINZI® after sequential CRT6,7
  • PACIFIC IIIA N2: Post-hoc analysis confirming treatment benefits with IMFINZI® in patients with stage IIIA-N2 NSCLC8
icon DownloadDownload PACIFIC flyer

* IMFINZI® is indicated for the treatment of patients with locally advanced, non-resectable NSCLC whose disease has not progressed after a definitive platinum-based CRT.1

CRT: chemoradiotherapy; NSCLC: non-small cell lung cancer; OS: Overall survival; PFS: progression-free survival; UR: unresectable.

References

  1. IMFINZI® Information for Healthcare Professionals. www.swissmedicinfo.ch.
  2. Spigel DR, et al. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022; 40 (12): 1301–1311.
  3. Antonia SJ, et al. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018; 379(24): 2342–2350.
  4. Girard N, et al. Treatment Characteristics and Real-World Progres­sion-Free Survival in Patients With Unresectable Stage III NSCLC Who Received Durvalumab After Chemoradiotherapy: Findings From the PACIFIC-R Study. J Thorac Oncol. 2023 Feb;18(2):181-193.
  5. Girard N, et al. Real-world overall survival (OS) with durvalumab (D) after chemoradiotherapy (CRT) in patients (pts) with unresectable stage III non-small-cell lung cancer (NSCLC): Interim analysis from the PA­CIFIC-R study. Immuno-Oncology and Technology. 2022; 16: 100163.
  6. Garassino MC, et al. Durvalumab After Sequential Chemoradiotherapy in Stage III, Unresectable NSCLC: The Phase 2 PACIFIC-6 Trial. J Thorac Oncol. 2022 Dec;17(12):1415-1427.
  7. Garassino MC, et al. Durvalumab after sequential chemoradiotherapy in patients with unresectable Stage III NSCLC: Final analysis from PACIFIC 6. Presentation LBA61, ESMO Congress 2023. Madrid, Spain, 20-24 October 2023.
  8. Senan S, et al. Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial. ESMO Open. 2022 Apr;7(2):100410.
  9. NCCN Guidelines NSCLC, online available: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf (last access: 02.02.2024).
  10. ESMO Guidelines NSCLC, online available: https://www.esmo.org/guidelines/guidelines-by-topic/esmo-clinical-practice-guidelines-lung-and-chest-tumours/early-stage-and-locally-advanced-non-metastatic-non-small-cell-lung-cancer (last access: 02.02.2024).
  11. List of specialities. www.spezialitätenliste.ch

Professionals can request the mentioned references from AstraZeneca AG.

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