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.
- 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.
PP-INO-GBR-0253. May 2020