Click here for Besponsa®▼ (inotuzumab ozogamicin) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
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:
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.
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
Here Dr. Anna Castleton discuss the key data for BESPONSA vs standard care from the INO-VATE study
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PP-PFE-GBR-2688. December 2020