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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.

Efficacy

Now you can aim higher in R/R ALL1-5

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  
The 2 primary endpoints were complete remission (including complete remission with incomplete haematologic recovery) and overall survival

INO-VATE ALL study design​​​​​​​1-2​​​​​​​

*All Ph+ patients must have been unresponsive to prior treatment with ≥1 second-/third-generation TKI and standard induction chemotherapy1,6
​​​​​​​ Number of Ph+ patients enrolled was capped at 20%, total n = 22/164 in the BESPONSA arm, n = 27/162 in the SC arm.2
†≥ 5% bone marrow blasts on local morphological analysis
​​​​​​​ALL, acute lymphoblastic leukaemia; AraC, cytarabine; CR, complete remission; CRi, complete remission with incomplete haematological recovery of peripheral blood counts; FLAG, fludarabine/AraC/granulocyte colony-stimulating factor; HiDAC, high-dose AraC; MXN, mitoxantrone; OS, overall survival; Ph+/–, Philadelphia chromosome-positive/-negative; R/R ALL, relapsed/refractory acute lymphoblastic leukaemia; SC, standard chemotherapy; TKI, tyrosine kinase inhibitor

Response rates (CR/CRi)​​​​​​​1

Aim for improved CR/CRi rates vs SC

In the INO-VATE study, 4 out of 5 patients achieved the primary endpoint of CR/CRi with single agent BESPONSA1*

Patients in the INO-VATE study achieving CR/CRi*

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.

Long term Overall Survival

Aim to increase long-term survival rates

A long-term OS analysis from the INO-VATE study reports longer OS with BESPONSA vs SC2

INO-VATE OS: Data across 50 months (data cut: January 2017); median OS follow-up: 29.6 (range, 1.7-49.7) months2

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

Probability of survival by time (ITT population)​​​​​​​

Follow up time

BESPONSA, %
(95% CI) n = 164

SC, %
(95% CI) n = 162

12 months3

33.6
(26.4-40.9)

32.0
(24.7-39.6)

24 months2,3

22.8
(16.7-29.6)

10.0
(5.7-15.5)

36 months2,3

20.3
(14.4-27.0)

6.5
(2.9-12.3)

BESPONSA more than trebled the 3-year Median OS rate vs SC (20.3% vs 6.5%)2. Overall HR for survival was 0.751 (95% CI, 0.588–0.959; 2-sided p-value = 0.0210)5​​​​​​​​​​​​​​

InO, inotuzumab ozogamicin; ITT, intention-to-treat; OS, Overall Survival

MRD rates by cycle

Aim for MRD negativity in cycles 1 and 24

In the full study population, of 164 BESPONSA patients 92 patients achieved CR/CRi with MRD negativity

Study populations

Timing of cumulative MRD negativity in patients achieving MRD-negative CR/CRi    (n = 92)4

*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

Bridging patients to transplant​​​​​​​

INO-VATE: More BESPONSA-treated patients proceeded to transplant than with standard chemotherapy2

CI, confidence interval; HSCT, haematopoietic stem cell transplantation
▼ 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. New Engl J Med. 2016;375:740-53.  
  2. Kantarjian HM, et al. Cancer 2019;125;2474–2487
  3. Stelljes M, et al. Presented at 44th Congress of the European Society for Blood and Marrow Transplantation, Lisbon, Portugal, 18‒21 March 2018. Oral presentation OS10–2.
  4. Jabbour E, et al. Leuk Res 2020; 88:106283. Supplementary appendix.
  5. BESPONSA Summary of Product Characteristics for Great Britain click here. BESPONSA Summary of Product Characteristics for Northern Ireland click here
  6.  Kantarjian HM, et al. New Engl J Med. 2016;375:740-53.  Supplementary appendix
PP-INO-GBR-0495. August 2021

Fast Facts

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

Download here

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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PP-PFE-GBR-3863. November 2021

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