MORE OR LESS? IMPACT OF DOSE NUMBER ON OUTCOMES OF PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA TREATED WITH INOTUZUMAB OZOGAMICIN
Author(s): ,
David I Marks
Affiliations:
University Hospitals Bristol,Bristol,United Kingdom
,
Daniel J DeAngelo
Affiliations:
Dana-Farber Cancer Institute,Boston, MA,United States
,
Elias Jabbour
Affiliations:
University of Texas MD Anderson Cancer Center,Houston, TX,United States
,
Anjali Advani
Affiliations:
Cleveland Clinic Taussig Cancer Institute,Cleveland, OH,United States
,
Susan O’Brien
Affiliations:
University of California, Irvine Medical Center,Orange, CA,United States
,
Tao Wang
Affiliations:
Pfizer, Inc,,Groton, CT,United States
,
Alexander Neuhof
Affiliations:
Pfizer Pharma GmbH,Berlin,Germany
,
Erik Vandendries
Affiliations:
Pfizer, Inc,,Cambridge, MA,United States
,
Hagop Kantarjian
Affiliations:
University of Texas MD Anderson Cancer Center,Houston, TX,United States
,
Wendy Stock
Affiliations:
University of California, Irvine Medical Center,Orange, CA,United States
,
Matthias Stelljes
Affiliations:
Universitätsklinikum Münster,Münster,Germany
Ryan Cassaday
Affiliations:
University of Washington School of Medicine and Fred Hutchinson Cancer Research Center,Seattle, WA,United States
EHA Library. I Marks D. 06/15/19; 267252; PS951
David I Marks
David I Marks
Contributions
Abstract

Abstract: PS951

Type: Poster Presentation

Presentation during EHA24: On Saturday, June 15, 2019 from 17:30 - 19:00

Location: Poster area

Background
In INO-VATE (NCT01564784), patients with relapsed/refractory acute lymphoblastic leukemia who were treated with inotuzumab ozogamicin (InO) vs standard chemotherapy had significantly greater remission rates and longer overall survival (OS), with more patients proceeding to stem-cell transplant (SCT).

Aims
Here we report outcomes by number of InO cycles (Cyc) received.

Methods
Methods are detailed in Kantarjian, NEJM 2016. Outcomes are reported based on number of InO Cyc received (≤3 or >3 Cyc with no SCT and ≤2 or >2 with SCT [consistent with current recommendations]) in patients who achieved complete remission (CR)/CR with incomplete hematologic recovery. Data cutoff: Jan 4, 2017.

Results

Among patients who responded but did not proceed to SCT, MRD-negativity was achieved by 88% of 32 patients receiving >3 Cyc vs 61% of 18 patients receiving ≤3 Cyc (P=0.037). Patients who had >3 Cyc had a longer duration of remission (HR 0.35, P=0.0005) and improved survival outcomes vs those who had ≤3 Cyc (Table). The rate of serious adverse events (AE) and the percentage of patients discontinuing treatment due to AEs was numerically lower with >3 Cyc vs ≤3 Cyc.

Among patients who responded and proceeded to SCT, the percentage achieving MRD-negativity (81% vs 69%, P=0.123) and the duration of remission (HR 1.37, P=0.848) were similar for those who had >2 Cyc (36 patients) vs ≤2 Cyc (35 patients). Patients with ≤2 Cyc had improved survival outcomes and non-relapse mortality (NRM) vs those with >2 Cyc (Table). 17.1% of patients receiving ≤2 Cyc and 33.3% of patients receiving >2 Cyc developed veno-occlusive disease (Table).

Conclusion
These results are in agreement with current recommendations that patients proceeding to SCT should receive ≤2 Cyc, whereas those not proceeding to SCT may benefit from receiving up to 6 cycles of therapy.

Session topic: 2. Acute lymphoblastic leukemia - Clinical

Keyword(s): Acute lymphoblastic leukemia, Clinical outcome

Abstract: PS951

Type: Poster Presentation

Presentation during EHA24: On Saturday, June 15, 2019 from 17:30 - 19:00

Location: Poster area

Background
In INO-VATE (NCT01564784), patients with relapsed/refractory acute lymphoblastic leukemia who were treated with inotuzumab ozogamicin (InO) vs standard chemotherapy had significantly greater remission rates and longer overall survival (OS), with more patients proceeding to stem-cell transplant (SCT).

Aims
Here we report outcomes by number of InO cycles (Cyc) received.

Methods
Methods are detailed in Kantarjian, NEJM 2016. Outcomes are reported based on number of InO Cyc received (≤3 or >3 Cyc with no SCT and ≤2 or >2 with SCT [consistent with current recommendations]) in patients who achieved complete remission (CR)/CR with incomplete hematologic recovery. Data cutoff: Jan 4, 2017.

Results

Among patients who responded but did not proceed to SCT, MRD-negativity was achieved by 88% of 32 patients receiving >3 Cyc vs 61% of 18 patients receiving ≤3 Cyc (P=0.037). Patients who had >3 Cyc had a longer duration of remission (HR 0.35, P=0.0005) and improved survival outcomes vs those who had ≤3 Cyc (Table). The rate of serious adverse events (AE) and the percentage of patients discontinuing treatment due to AEs was numerically lower with >3 Cyc vs ≤3 Cyc.

Among patients who responded and proceeded to SCT, the percentage achieving MRD-negativity (81% vs 69%, P=0.123) and the duration of remission (HR 1.37, P=0.848) were similar for those who had >2 Cyc (36 patients) vs ≤2 Cyc (35 patients). Patients with ≤2 Cyc had improved survival outcomes and non-relapse mortality (NRM) vs those with >2 Cyc (Table). 17.1% of patients receiving ≤2 Cyc and 33.3% of patients receiving >2 Cyc developed veno-occlusive disease (Table).

Conclusion
These results are in agreement with current recommendations that patients proceeding to SCT should receive ≤2 Cyc, whereas those not proceeding to SCT may benefit from receiving up to 6 cycles of therapy.

Session topic: 2. Acute lymphoblastic leukemia - Clinical

Keyword(s): Acute lymphoblastic leukemia, Clinical outcome

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