TOWER study - In the randomised, open-label, phase 3 study the efficacy of Blinatumomab has been investigated against standard of care backbone-chemotherapy in patients with relapsed or refractory B-precursor-ALL (with >5% blasts in bone marrow and relapsed at one time after allogenic HSCT, untreated first relapse after a first remission phase of ≤12 months or refractory to last therapy).
Randomisation (2:1) was stratified by age (<35 yrs vs ≥35 yrs), prior salvage-theapies and prior HSCT. Overall survival (OS) was the 1° endpoint.
(Kantarjan et al. N Engl J Med 2017)
The additional benefit regarding OS and remission with Blinatumomab was independent of prior salvage therapy and was consistent over the various salvage stages. OS and remission
were in both arms better in the group without salvage therapy than in the salvage group. Patients with prior salvage therapy received more often an alloHSCT after Blinatumomab than after SOC. (Analysis by Dombret et al. EHA 2017)
TOWER by 1st salvage
(Dombret et al. EHA 2017)
Further analyses from TOWER:
TOWER by HSCT
(Gökbuget et al. EBMT Annual Meeting 2018)
Blinatumomab maintenance therapy after hematologic remission (Rambaldi et al. ASH 2017)
Quality of Life with Blinatumomab treatment (Topp et al. ASH 2017)
Baselines biomarkers on outcomes with Blinatumomab treatment (Wei et al. ASH 2017)
BLAST Study - Blinatumomab in adult patients with MRD positive B-cell-precursor ALL
Efficacy and safety of Blinatumomab were investigated in an open, single arm, multicentric study. Patients were ≥ 18 years, with a minimum of 3 blocks of standard-induction therapy against ALL, were in complete hematologic remission and had a molecular treatment failure or a molecluar relapse (defined as MRD ≥ 10-3).
1° Endpoint: MRD negativity after first cycle with Blinatumomab.
- Hematologic Relapse Free Survival (RFS) at month 18; OS; time to hematologic relapse; duration of MRD-negativity
- Incidence and seriousness of AEs
(Gökbuget et al. Blood 2018)
Blinatumomab pediatric study: von Stackelberg3
Phase 1/2 Maximum Tolerated Dose and Efficacy study of Blinatumomab in pediatric patients with relapsed/refractory ALL.
- Blinatumomab has anti-leukaemic activity in heavily pre-treated pediatric patients with r/r ALL, including ability to induce MRD-negative remissions
- Most patients were refractory or had relapsed after HSCT; 71% of patients had relapsed within 6 months of the last salvage treatment
- 39% of patients achieved CR, and 52% of these became MRD-negative
- Blinatumomab has the potential to provide a bridge to HSCT
- 48% of patients achieving CR went on to receive alloHSCT
- Adverse events associated with Blinatumomab treatment consistent with previous experience in this disease setting
- Low incidence of severe CRS (any grade: 11% pts; ≥ grade 3: 6% pts) and neurological events (≤ grade 2: 20% pts; grade 3: 4% pts).
Blinatumomab pediatric study Von Stackelberg
Abbreviations: Overall Survival (OS); Month (Mo); Hazard Ratio (HR); versus (vs); Week (Wk); Standard of Care (SOC); Relapse Free Survival (RFS)
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- Kantarjian H, et al. N Engl J Med. 2017;376:836–47
- Gökbuget N, et al. Blood. 2018;131(14):1522-1531
- von Stackelberg A, et al. J Clin Oncol 2016;34:4381–9