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Click here for Besponsa® (inotuzumab ozogamicin) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

Key Highlights

Now you can aim higher in R/R ALL1–4

The pivotal registration study for BESPONSA® (N=164 [164 received treatment) was an open-label, dual arm, randomised Phase III study in patients aged 18 or over with relapsed or refractory CD-22, Ph+ or Ph- ALL versus investigator’s choice of standard chemotherapy (N=162).1

Investigator's choice of chemotherapy (N=162 [143 received treatment]), specifically fludarabine plus cytarabine plus granulocyte colony-stimulating factor (FLAG) (N=102 [93 received treatment]), mitoxantrone/cytarabine (MXN/Ara-C) (N=38 [33 received treatment]), or high dose cytarabine (HIDAC) (n=22 [17 received treatment])2

The 2 primary endpoints were:

  • Complete remission (including complete remission with incomplete haematologic recovery)
  • Overall survival

Compared with standard chemotherapy, BESPONSA offers in R/R ALL:

Title

With BESPONSA, bridge more of your R/R ALL patients to curative therapy than with standard chemotherapy1

​​​​​​​*Data for CR/CRi from the prespecified primary analysis of n = 109 in either arm; the data cut-off date was 08 March 2016. Between-group differences were 51.4% (97.5% CI, 38.4–64.3) for CR/CRi and 50.3% (97.5% CI, 29.9–70.6) for CR/CRi (MRD negative); p < 0.001. The two-sided p values for between-group differences were determined by means of the chi-square test or Fisher’s exact test (if any cell count was < 5).
†Data for transplant and OS analysis from the ITT population: 2-year OS 22.8% vs 10.0% with standard chemotherapy;2 the data cut-off date was 08 March 2016.1
‡HR, 0.77 (97.5% CI, 0.58–1.03; p = 0.04). Additional OS data are available in the current BESPONSA SmPC.2 A modified analysis of median OS data, carried out by the European Medicines Agency, demonstrated a significantly longer median OS with BESPONSA compared with standard chemotherapy.5

CI, confidence interval; CR, complete remission; CRi, complete remission with incomplete haematological recovery of peripheral blood counts; HR, hazard ratio; HSCT, haematopoietic stem cell transplantation; ITT, intention-to-treat; MRD, minimal residual disease; OS, overall survival; QoL, quality of life; R/R ALL, relapsed/refractory acute lymphoblastic leukaemia; SC, standard chemotherapy; SmPC, Summary of Product Characteristics.

Explore more

Developments in Leukaemia Care

Watch Professor David Marks discuss targeted therapies and the INO-VATE study, including 3 year follow up and impact of allogeneic bone marrow transplantation on survival

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Key data from the INO-VATE study 

Here Dr. Anna Castleton discuss the key data for BESPONSA vs standard care from the INO-VATE study

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 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
References
  1. Kantarjian HM, et al. N Engl J Med 2016;375:740–753
  2. Pfizer Limited. BESPONSA Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/650/smpc [accessed March 2021].
  3. Marks DI, et al. Cancer Med 2019; 5959-5968
  4. Kantarjian HM, et al. Cancer 2018; 124; 2151-2160
  5. European Medicines Agency. EPAR, inotuzumab (EMA/289046/2017). Available at: https://www.ema.europa.eu/en/documents/assessment-report/besponsa-epar-public-assessment-report_en.pdf [accessed March 2021]
PP-INO-GBR-0386. March 2021

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