BESPONSA® (inotuzumab ozogamicin) | Adverse Events Management: VOD/SOS | PfizerPro Ireland

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Adverse Event Management:
VOD/SOS

Evaluate VOD Risk

Proactively Manage VOD

Salvage line post-hoc analysis

Risk of VOD in BESPONSA-treated Patients^1-4

VOD in INO-VATE ALL

BESPONSA increased the risk of VOD/SOS above that of SC regimens (reported in 23/164 [14%] patients versus 3/143 [2.1%] patients). This risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment (18/79 [23%] patients)^1,2
VOD/SOS was reported up to 56 days after the last dose during treatment or during follow-up without an intervening HSCT¹
Median time to onset of VOD after HSCT in the BESPONSA arm was 15 days (range 3–57 days)¹
The risk of VOD can be reduced through risk mitigation strategies^1,3

Note: Due to the small sample size, results should be interpreted with caution.
Additionally, some patients may not have developed VOD at the time of this analysis.⁴

ALL=acute lymphoblastic leukemia; HSCT=hematopoietic stem cell transplantation; S1=salvage 1; S2=salvage 2; SC=standard chemotherapy; SOS=sinusoidal obstruction syndrome; VOD=veno-occlusive disease.

BESPONSA Summary of Product Characteristics

Kantarjian HM, et al. Cancer. 2019;125(14):2474-2487.

Kebriaei P, et al. Bone Marrow Transplant 2018;53(4):449-456.

Jabbour E, et al. Leuk Lymphoma. 2020;61(8):2012-2015.

Risk Factors and Strategies for Mitigating VOD

VOD Risk Factors With BESPONSA After HSCT in INO-VATE ALL¹

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Variable tested			Odds ratio
Multivariate analysis
Conditioning regimens containing dual alkylators			8.61 P= 0.015
Bilirubin levels ≥ ULN at last measurement before conditioning therapy			7.08 P = 0.011
Bilirubin levels ≥ ULN at last measurement before follow-up HSCT			15.31 P = 0.009
Prior HSCT			6.02 P = 0.032
Univariate analysis^a
Age ≥ 55 years			3.25 2-sided P = 0.048
Number of treatment cycles received			1.56 2-sided P = 0.048

ALL=acute lymphoblastic leukemia; HSCT=hematopoietic stem cell transplantation; ULN=upper limit of normal; VOD=veno-occlusive disease.

Treatment Considerations for Patients Proceeding to HSCT^2,3

Conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ ULN before HSCT are significantly associated with an increased risk of VOD³

a Additional VOD/SOS risk factors that were significant in a univariate analysis but not the multivariate analysis.¹

ALT=alanine aminotransferase; AST=aspartate aminotransferase; CR=complete remission; CRi=complete remission with incomplete hematologic recovery of peripheral blood counts; HSCT=hematopoietic stem cell transplantation; MRD=measurable residual disease; SOS=sinusoidal obstruction syndrome; ULN=upper limit of normal; VOD=veno-occlusive disease.

Kantarjian HM et al. Cancer 2019;125(14):2474–2487.

Kebriaei P, et al. Bone Marrow Transplant. 2018;53(4):449-456.

BESPONSA Summary of Product Characteristics

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Post HSCT Survival

Short overview showing post HSCT survival outcomes with BESPONSA from INO-VATE long term follow-up and pooled analysis

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Key Data From BESPONSA Outcomes by Salvage Lines

Click here to view the key data from publication entitled, “Impact of salvage treatment phase on inotuzumab ozogamicin treatment for relapsed/refractory acute lymphoblastic leukemia: an update from the INO-VATE final study database”

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BESPONSA RWE in R/R B-Cell ALL

Explore BESPONSA outcomes and safety in RWE

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ALL=acute lymphoblastic leukemia; HSCT=hematopoietic stem cell transplantation; R/R=relapsed/refractory; RWE=real-world evidence; SmPC=Summary of Product Characteristics; SOS=sinusoidal obstruction syndrome; VOD=veno-occlusive disease.

Proactively Manage VOD^1-3

EBMT diagnostic, prevention and treatment recommendations, please also view the BESPONSA SmPC here

Recommendations Diagnostic Criteria for VOD/SOS^1,2:

Classical VOD/SOS (≤ 21 days after HSCT)

Bilirubin ≥ 34 µmol/L (≥ 2 mg/dL) and two of:
- Painful hepatomegaly;
- Weight gain > 5%;
- Ascites

Late onset VOD/SOS (> 21 days after HSCT)

Classical VOD/SOS beyond Day 21

Histologically proven VOD/SOS

Two or more of:
- Bilirubin ≥ 34 μmol/L (≥ 2 mg/dL)
- Painful hepatomegaly
- Weight gain > 5%
- Ascites

AND

Hemodynamical and/or ultrasound evidence of VOD/SOS

Recommendations for The Prevention and Therapeutic Management of VOD/SOS:

View Revised EBMT Diagnosis and Severity Criteria

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View the EBMT VOD Position Statement

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Post HSCT Survival

Short overview showing post HSCT survival outcomes with BESPONSA from INO-VATE long term follow-up and pooled analysis

Download Here

Key Data From BESPONSA Outcomes by Salvage Lines

Watch video

BESPONSA RWE in R/R B-Cell ALL

Explore BESPONSA outcomes and safety in RWE

Download here

^aMost patient- and hepatic-related risk factors are impossible to reverse.
ALL=acute lymphoblastic leukemia; EBMT = The European Society for Blood and Marrow Transplantation; HSCT=hematopoietic stem cell transplantation; R/R=relapsed/refractory; RWE=real-world evidence; SmPC=Summary of Product Characteristics; SOS=sinusoidal obstruction syndrome; VOD=veno-occlusive disease.

References:

Mohty M, et al. Bone Marrow Transplant 2016;51(7):906–912.

Mohty M, et al. Bone Marrow Transplant 2015;50(6):781–789.

BESPONSA Summary of Product Characteristics

Kebriaei P, et al. Bone Marrow Transplant 2018;53(4):449–456.

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Post Transplant Outcomes and VOD Mitigation Strategies

Please click here to view the importance of transplant and VOD mitigation with BESPONSA in patients with R/R B-Cell ALL

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PP-INO-IRL-0111 January 2023

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