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QARZIBA®'s efficacy and safety profiles
Efficacy data

Efficacy data

Treat your eligible high-risk neuroblastoma patients with QARZIBA® with the confidence that both its efficacy and safety profiles are backed up by solid data. QARZIBA® has been studied in over 400 patients across its clinical programme.1-4

It has been shown to improve survival versus a historical cohort, in both newly diagnosed and relapsed/refractory settings:

Newly diagnosed:
In a historical control analysis, the 5-year EFS and OS for QARZIBA®+ IL-2 + isotretinoin (n=378) was significantly higher than the previous standard of care (n=466; both p<0.001).3,5

5-year EFS5

Adapted from: Ladenstein et al. 2020.

Abbr: EFS, event-free survival; IL-2, interleukin-2; CI, confidence interval.

15%

5-year EFS improvement

(additional percentage points)

QARZIBA® ± IL-2 + isotretinoin

378 patients, 161 events

2-year EFS: 65% (95% CI, 60–69)

5-year EFS: 57% (95% CI, 51–62)

Historical control (isotretinoin)

466 patients, 276 events

2-year EFS: 50% (95% CI, 45–54)

5-year EFS: 42% (95% CI, 38–47)

5-year OS5

Adapted from: Ladenstein et al. 2020.

Abbr: OS, overall survival; IL-2, interleukin-2; CI, confidence interval.

14%

5-year OS improvement

(additional percentage points)

QARZIBA® ± IL-2 + isotretinoin

378 patients, 127 events

2-year OS: 77% (95% CI, 72–81)

5-year OS: 64% (95% CI, 59–69)

Historical control (isotretinoin)

466 patients, 245 events

2-year OS: 69% (95% CI, 65–73)

5-year OS: 50% (95% CI, 46–55)

Retrospective studies in patients with relapsed/refractory disease:
QARZIBA® + IL-2 + isotretinoin significantly improved 3-year OS in relapsed neuroblastoma patients (n=48) vs:6-8

  • A historical control cohort (n=29) derived from the AIEOP registry (50% vs 24%, P=0.0031)
  • A historical control cohort (n=52) derived from the R1 trial (50% vs 28%, P=0.0302)
jamie-kite-path@2x

3-year OS vs Italian Neuroblastoma Registry6-8

Adapted from: European Medicines Agency. Assessment Report. Dinutuximab beta. EMA/263814/2017.

Abbr: AIEOP, Italian Association of Pediatric Heamatology and Oncology; OS, overall survival; IL-2, interleukin-2.

26%

3-year OS improvement

(additional percentage points)

QARZIBA® ± IL-2 + isotretinoin

48 patients

3-year OS: 50%

AIEOP registry

29 patients

3-year OS: 24%

3-year OS vs HR/NBL1 (APN311-302) R1 cohort6-8

Adapted from: European Medicines Agency. Assessment Report. Dinutuximab beta. EMA/263814/2017.

Abbr: OS, overall survival; IL-2, interleukin-2.

22%

3-year OS improvement

(additional percentage points)

QARZIBA® ± IL-2 + isotretinoin

48 patients

3-year OS: 50%

R1 cohort

52 patients

3-year OS: 28%

Other pages in this section

Safety profile

jamie-mum-path@2x

GL-DNB-2200038 | December 2022

Abbreviations

AIEOP=Italian Association of Pediatric Hematology and Oncology; CI=confidence interval; EFS=event-free survival; IL-2=Interleukin 2; OS=overall survival.

References

  1. Ladenstein R et al. Lancet Oncol 2018; 19: 1617–1629.
  2. Ladenstein R et al. Oral Presentation. ASCO 2019.
  3. QARZIBA® (dinutuximab beta). Summary of product characteristics.
  4. Periodic Benefit-Risk Evaluation Report. Nov 2020 to Nov 2021. Data on file.
  5. Ladenstein R et al. Cancers 2020; 12 (2): 309.
  6. EMA. Qarziba (previously Dinutuximab beta EUSA and Apeiron). Available at: https://www.ema.europa.eu/en/documents/product-information/qarziba-epar-product-information_en-0.pdf. Accessed November 2022.
  7. Garaventa A et al. Eur J Cancer 2009; 45 (16): 2835–2842.
  8. Mueller I et al. MAbs 2018; 10 (1): 55–61.

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