Clinical Trial

INO-VATE ALL: a global, randomized, Phase 3 clinical trial

BESPONSA demonstrated efficacy and safety as a single agent vs standard chemotherapy (SC) in 326 adult patients with Ph-negative (Ph–) or Ph-positive (Ph+) relapsed or refractory ALL1-3

 

 
  • The efficacy of BESPONSA was established on the basis of CR, duration of CR, and proportion of MRD-negative CR in the first 218 patients randomized

a1.8 mg/m2 was fractionated as 0.8 mg/m2 , 0.5 mg/m2 , and 0.5 mg/m2 on Days 1, 8, and 15, respectively. 1.5 mg/m2 was fractionated as 0.5 mg/m2 on Days 1, 8, and 15.

 

Additional inclusion criteria1

  • Patients were required to have ≥5% bone marrow blasts
  • Patients must have received 1 or 2 previous induction chemotherapy regimens for ALL
  • Patients with Ph+ B-cell precursor ALL must have failed treatment with at least 1 TKI and SC

 

Study populations1,3

 

 

ALL=acute lymphoblastic leukemia; Ara-C + MXN=cytarabine + mitoxantrone; CR=complete remission; CRi=complete remission with incomplete hematologic recovery; DoR=duration of remission; FLAG=fludarabine + cytarabine + granulocyte colony-stimulating factor; HiDAC=high-dose cytarabine; HSCT=hematopoietic stem cell transplant; MRD=minimal residual disease; OS=overall survival; Ph=Philadelphia chromosome; TKI=tyrosine kinase inhibitor.

 

References
  1. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.
  2. Kantarjian HM, DeAngelo DJ, Stelljes M, et al. lnotuzumab ozogamicin versus standard therapy for acute lymphoblastic leukemia. N Engl J Med. 2016;375(8):740-753.
  3. Data on file. Pfizer Inc, New York, NY.

 

The majority of patients in the INO-VATE ALL study1,2:

  • Were in first salvage
  • Had no prior HSCT
  • Had high baseline disease burden (≥50% bone marrow blasts)
  • Had a short duration of first remission (<12 months)

ECOG=Eastern Cooperative Oncology Group; HSCT=hematopoietic stem cell transplant; Ph+=Philadelphia chromosome–positive; SC=standard chemotherapy.

 

References
  1. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.
  2. Data on file. Pfizer Inc, New York, NY.