Efficacy

BESPONSA more than doubled the rate of CR/CRi compared to SC1

Superior CR/CRia rate

In the remission analysis of 218 randomized patients, 73% (64/88) treated with BESPONSA responded in Cycle 1 and 24% (21/88) responded in Cycle 2. All responses occurred within 3 cycles.1,2

 

CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete hematologic recovery; SC=standard chemotherapy.

aCR, per Endpoint Adjudication Committee (EAC), was defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets ≥100 x 109/L and absolute neutrophil counts [ANC] ≥1 x 109/L), and resolution of any extramedullary disease. CRi, per EAC, was defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100 x 109/L and/or ANC <1 x 109/L), and resolution of any extramedullary disease.

b1-sided P value using chi-square test.

 

CR/CRi rates were evaluated across a range of patients1,3

  • These subgroup analyses were exploratory and not powered to detect statistical significance or demonstrate efficacy. Small patient numbers can be a limitation of these analyses

Cl=confidence interval; CR=complete remission; CRi=complete remission with incomplete hematologic recovery; HSCT=hematopoietic stem cell transplant; Ph=Philadelphia chromosome; SC=standard chemotherapy.

cPrespecified stratification factor.

 

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

 

MRD-negativity rate among responding patients was more than double in patients receiving BESPONSA vs SC1

Higher rate of MRD-negativea CR/CRi

 

  • MRD-negative CR rate was 89.7% (35/39; 95% CI, 75.8-97.1) with BESPONSA vs 31.6% (6/19; 95% CI, 12.6-56.6) with SC
  • MRD-negative CRi rate was 69.4% (34/49; 95% CI, 54.6-81.7) with BESPONSA vs 23.1% (3/13; 95% CI, 5.0-53.8) with SC

CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete hematologic recovery; MRD=minimal residual disease; SC=standard chemotherapy.

aPatients were considered MRD-negative when leukemic cells comprised <1 x 10-4 of bone marrow nucleated cells, as measured by flow cytometry.

 

Reference
  1. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.

 

Rates of HSCT were more than double with BESPONSA vs SC1,2

Overall                    Direct to HSCTa

  • The median time from the last dose of BESPONSA to HSCT was 4.9 weeks (n=71; range, 1-19 weeks)

Consider involving the transplant team early in treatment planning, particularly when assessing a patient receiving BESPONSA for HSCT eligibility.

CI=confidence interval; HSCT=hematopoietic stem cell transplant; SC=standard chemotherapy.

aThis rate represents the percentage of patients who proceeded directly to HSCT without the use of additional or follow-up induction therapies.

 

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

 

Median duration of remission was longer with BESPONSA than with SC1

Median duration of CR/CRia

 

  • Median duration of CR was 8.0 months (n=39; 95% CI, 4.9-10.4) with BESPONSA vs 4.9 months (n=18; 95% CI, 2.9-7.2) with SC
  • Median duration of CRi was 4.6 months (n=45; 95% CI, 3.7-5.7) with BESPONSA vs 2.9 months (n=14; 95% CI, 0.6-5.7) with SC

CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete hematologic recovery; DoR=duration of remission; SC=standard chemotherapy.

aDoR, based on a later cutoff date than CR/CRi, was defined for patients who achieved CR/CRi per investigator's assessment as time since first response of CR/CRi per investigator's assessment to the date of a progression-free survival (PFS) event or censoring date if no PFS event was documented.

 

Reference
  1. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.

 

BESPONSA demonstrated a median OS of 7.7 months vs 6.2 months with SC, which represents a 25% relative reduction in the risk of death1,2

  • The analysis of OS did not meet a prespecified boundary for statistical significance of P=0.0104

CI=confdence interval; HR=hazard ratio; OS=overall survival; SC=standard chemotherapy.

a1-sided P value using log-rank test.

 

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