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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).1The 2 primary endpoints were complete remission (including complete remission with incomplete haematologic recovery) and overall survival
INO-VATE ALL study design1-2
*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, % |
SC, % |
|---|---|---|
12 months3 |
33.6 |
32.0 |
24 months2,3 |
22.8 |
10.0 |
36 months2,3 |
20.3 |
6.5 |
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
- Kantarjian HM, et al. New Engl J Med. 2016;375:740-53.
- Kantarjian HM, et al. Cancer 2019;125;2474–2487
- 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.
- Jabbour E, et al. Leuk Res 2020; 88:106283. Supplementary appendix.
- BESPONSA Summary of Product Characteristics for Great Britain click here. BESPONSA Summary of Product Characteristics for Northern Ireland click here
- Kantarjian HM, et al. New Engl J Med. 2016;375:740-53. Supplementary appendix
Quick Links
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
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