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Poster display session

3802 - Quantitative Assessment of Inotuzumab Ozogamicin (InO) Response Relative to Investigator’s Choice of Chemotherapy (ICC) in Adults With Relapsed or Refractory (R/R) CD22+ B-Cell Acute Lymphoblastic Leukemia (ALL)

Date

09 Sep 2017

Session

Poster display session

Presenters

Ana Ruiz-Garcia

Citation

Annals of Oncology (2017) 28 (suppl_5): v355-v371. 10.1093/annonc/mdx373

Authors

A. Ruiz-Garcia1, E. Vandendries2, D.J. Deangelo3, H.M. Kantarjian4, J. Boni5

Author affiliations

  • 1 Clinical Pharmacology, Pfizer Inc, 92121 - San Diego/US
  • 2 Clinical Research And Development Hematology, Pfizer Inc, Cambridge/US
  • 3 Center For Hematologic Oncology, Dana-Farber Cancer Institute, Boston/US
  • 4 Department Of Leukemia, MD Anderson Cancer Center, Houston/US
  • 5 Clinical Pharmacology, Pfizer Inc, Collegeville/US
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Resources

Abstract 3802

Background

InO is a humanized CD22-targeted antibody conjugated to N-acetyl-γ-calicheamicin, a potent cytotoxic antibiotic. InO was administered to adult patients with R/R CD22+ B-cell ALL in a phase 1/2 (B1931010) study, and a phase 3 (INO-VATE) study that compared single-agent InO with ICC. The goal of this analysis was to quantify differences in response for the endpoints complete response (CR)/CR with incomplete hematologic recovery (CRi) and minimal residual disease-negativity (MRD (-)) for patients treated with InO relative to ICC.

Methods

The efficacy endpoints analyzed were CR/CRi per investigator’s assessment and MRD (-). The modeling analyses were performed using generalized binomial logistic regression, which allows constructing a linear continuous predictor for probabilities of response ranging from 0%–100%. 2 treatment arms were considered: single agent InO or ICC (fludarabine, cytarabine, granulocyte colony-stimulating factor; cytarabine with mitoxantrone; or high-dose cytarabine). Additional potential predictors of response (eg, baseline demographic/patient characteristics, laboratory values) were also tested.

Results

For the CR/CRi efficacy endpoint, only 3 variables were statistically significant predictors of achieving CR/CRi: treatment arm, baseline ECOG (BECOG) performance status, and baseline absolute blasts in peripheral blood (BLSTABL). For the MRD (-) endpoint, 5 variables were statistically significant predictors of achieving MRD(-): treatment arm, BECOG performance status, baseline cytogenetic characteristics, prior hematopoietic stem cell transplant before study therapy, and BLSTABL.Table:

1033P

Endpoint, n (%)CategoryStudy B1931010 InO (n = 72)INO-VATE InO Arm (n = 162)INO-VATE ICC Arm (n = 143)Total (N = 377)
MRD-negativity*No31 (43)59 (36)115 (80)205 (54)
Yes41 (57)97 (60)23 (16)161 (43)
Missing0 (0)6 (4)5 (3)11 (3)
CR/CRiNo23 (32)42 (26)95 (66)160 (42)
Yes49 (68)120 (74)48 (34)217 (58)
*

When CR/CRi was not achieved and MRD was missing, MRD was considered not achieved.

Conclusions

The odds of achieving CR/CRi and MRD(-) with InO were approximately 7 and 13 times higher, respectively, than ICC.

Clinical trial identification

NCT01363297, NCT01564784

Legal entity responsible for the study

Pfizer Inc

Funding

Pfizer Inc

Disclosure

A. Ruiz-Garcia, E. Vandendries: Employee of and owns stocks in Pfizer Inc. D.J. DeAngelo: Served on advisory boards for Pfizer Inc. H.M. Kantarjian: Received research grants from Pfizer, Amgen, Astex, Novartis, and Bristol-Myers Squib. J. Boni: Was an employee of Pfizer Inc at the time the study was conducted.

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