The content of this website has been produced in line with the BESPONSA®▼ (inotuzumab ozogamicin) Summary of Product Characteristics for Great Britain and is intended for Healthcare Professionals based in Great Britain. BESPONSA▼ Prescribing Information for Great Britain click here. BESPONSA▼ Prescribing Information for Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
In the INO-VATE study, 4 out of 5 patients achieved the primary endpoint of CR/CRi with single agent BESPONSA1*
Adapted from: Kantarjian HM, et al. 20161.
*CR/CRi rates in the remission-analysis population, which include the first 218 patients who underwent randomisation in the intention-to-treat population (inotuzumab ozogamicin, n = 109; standard chemotherapy, n = 109).
Endpoint was complete remission or complete remission with incomplete haematological recovery.
CI, confidence interval; CR, complete remission; CRi, complete remission with incomplete haematological recovery of peripheral blood counts, SC, standard chemotherapy.
A long-term OS analysis from the INO-VATE study reports longer OS with BESPONSA vs SC2
HR 0.751 (95% CI, 0.588–0.959, Two-sided p = 0.0210)5
Adapted from: Kantarjian HM, et al. 2019.2
CI, confidence interval; ITT, intention-to-treat; SC, standard chemotherapy; OS, Overall Survival
Follow up time |
BESPONSA, % |
SC, % |
---|---|---|
12 months3 |
33.6 |
32.0 |
24 months2,3 |
22.8 |
10.0 |
36 months2,3 |
20.3 |
6.5 |
InO, inotuzumab ozogamicin; ITT, intention-to-treat; OS, Overall Survival
In the full study population, of 164 BESPONSA patients 92 patients achieved CR/CRi with MRD negativity
*Patients with ≥ 1 MRD measurement < 0.01% within each cycle; patients who had MRD < 0.01% previously not included. MRD negativity is defined as minimum MRD < 0.01%4. For patients proceeding to HSCT, the recommended duration of treatment with BESPONSA is 2 cycles. A third cycle may be considered for patients who do not achieve CR/CRi and MRD negativity after 2 cycles5.
CR, complete remission; CRi, complete remission with incomplete haematological recovery of peripheral blood counts; InO, inotuzumab ozogamicin; ITT, intention-to-treat; MRD, minimal residual disease; SC, standard chemotherapy
CI, confidence interval; HSCT, haematopoietic stem cell transplantation
Download the Fast Facts Guide holding the key information for BESPONSA including mode of action, INO-VATE study design, INO-VATE results; efficacy and safety profile
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