Efficacy

Now you can aim higher in R/R ALL1–4

The pivotal registration study for BESPONSA® was an open-label, 2 group, randomised Phase III study in patients aged 18 or over with relapsed or refractory CD-22, Ph+ or Ph- ALL.1

The 2 primary endpoints were:

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

Aim for improved CR/CRi rates and MRD negativity1

In the INO-VATE study, 4 out of 5 patients achieved the primary endpoint of CR/CRi with single agent BESPONSA®1*

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.

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

Adapted from: Kantarjian HM, et al. 2019.2

CI, confidence interval;  ITT, intention-to-treat; SC, standard chemotherapy; OS, Overall Survival.

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

Best MRD repsonse by cycle in CR/CRi patients treated with BESPONSA®  who achieved MRD-negativity

Patients with ≥ 1 MRD measurement < 0.01% within each cycle; patients who had MRD < 0.01% previously not included.4

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.

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

Ph+, Philadelphia chromosome positive; Ph-, Philadelphia chromosome negative; R/R ALL, relapsed/refractory acute lymphoblastic leukaemia. 

References

  1. Kantarjian HM, et al. New Engl J Med. 2016;375:740-53.  
  2. Kantarjian HM, et al. Cancer 2019;125;24742487
  3. Stelljes M, et al. Presented at 44th Congress of the European Society for Blood and Marrow Transplantation, Lisbon, Portugal, 1821 March 2018. Oral presentation OS102.
  4. Jabbour E, et al. Leuk Res 2020; 88:106283. Supplementary appendix.

PP-INO-GBR-0253. May 2020