Clinical Trial

INO-VATE ALL: a global, randomized, Phase 3 clinical trial2,3

BESPONSA demonstrated efficacy and safety as a single agent vs SC in 326 adult patients with Ph– or Ph+ R/R ALL2,4

*1.8 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.

  • 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 randomized2

Additional inclusion criteria2

  • 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 populations2,4

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, and granulocyte colony-stimulating factor; HiDAC=high-dose cytarabine; HSCT=hematopoietic stem cell transplant; MRD=minimal residual disease; OS=overall survival; Ph–=Philadelphia chromosome–negative; Ph+=Philadelphia chromosome–positive; R/R=relapsed or refractory; SC=standard chemotherapy; TKI=tyrosine kinase inhibitor.

References
  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Lymphoblastic Leukemia V.1.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed February 26, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way.
  2. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.
  3. 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.
  4. Data on file. Pfizer Inc., New York, NY.

Patient characteristics in the INO-VATE ALL trial2,3

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

References
  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Lymphoblastic Leukemia V.1.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed February 26, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way.
  2. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.
  3. Data on file. Pfizer Inc., New York, NY.

The majority of patients were in first salvage, had no prior HSCT, had high tumor burden (baseline BMBs), and had a short duration of first remission2,3

The INO-VATE ALL study also included patients with Ph+ disease and EMD* or LBL2,3

Patients with Ph+ disease were required to have failed treatment with at least 1 TKI and SC.

Patients with LBL were allowed in the study, provided bone marrow involvement was ≥5%.

*Included lesions that could be accurately measured in 2 dimensions with a greatest transverse diameter of ≥1 cm, palpable lesions with both diameters ≥2 cm, or all other lesions documented by indirect evidence only (eg, lab values).3

BMB=bone marrow blast; EMD=extramedullary disease; HSCT=hematopoietic stem cell transplant; LBL=lymphoblastic lymphoma; Ph–=Philadelphia chromosome–negative; Ph+=Philadelphia chromosome–positive.

References
  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Lymphoblastic Leukemia V.1.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed February 26, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way.
  2. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.
  3. Data on file. Pfizer Inc., New York, NY.