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Adv Ther. 2019 Aug;36(8):2147-2160. doi: 10.1007/s12325-019-00991-w. Epub 2019 May 28.

Indirect Treatment Comparison of Inotuzumab Ozogamicin Versus Blinatumomab for Relapsed or Refractory Acute Lymphoblastic Leukemia.

Author information

1
Evidera, St-Laurent, QC, Canada. irina.proskorovsky@evidera.com.
2
Pfizer Inc, New York, NY, USA.
3
Evidera, Waltham, MA, USA.
4
Pfizer Inc, Cambridge, MA, USA.
5
Evidera, St-Laurent, QC, Canada.
6
Pfizer Inc, Groton, CT, USA.
7
University Hospital, Münster, Germany.

Abstract

INTRODUCTION:

No head-to-head studies have compared inotuzumab ozogamicin (InO) and blinatumomab (Blina) for the treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). Indirect treatment comparisons (ITCs), namely network meta-analysis (NMA), anchored matching-adjusted indirect comparison (MAIC), and simulated treatment comparison (STC), were conducted to compare the relative efficacy of these therapies.

METHODS:

Patient-level data from a study that evaluated InO with standard of care (SoC) chemotherapy (INO-VATE-ALL) and published data from a study that evaluated Blina with SoC chemotherapy (TOWER) were used in the analyses. Endpoints evaluated included remission rate defined as complete remission or complete remission with incomplete hematologic recovery (CR/CRi), hematopoietic stem cell transplantation (HSCT), overall survival (OS), and event-free survival (EFS). For each outcome, treatment-effect modifiers were adjusted for in the anchored MAIC and STC analyses.

RESULTS:

Analyses showed statistically significant higher rates of remission and HSCT with InO compared to Blina irrespective of the ITC method used or measure of the effect (i.e., odds ratio [OR] or rate difference). The treatment effects derived from the MAIC and STC analyses were consistent and stronger than those estimated from the NMA. A trend favoring InO was detected for EFS. The ITC results for OS suggest no difference between InO and Blina.

CONCLUSION:

Results from these ITCs indicated a statistically significant advantage for InO over Blina for rates of remission and HSCT in adults with relapsed or refractory B cell precursor ALL. It was not possible to fully adjust for all treatment-effect modifiers, and the similarity in chemotherapy regimens used in the SoC comparator arms of the INO-VATE-ALL and TOWER studies is worthy of further exploration. Both studies, however, used chemotherapy regimens that have a low response rate; therefore, no significant differences in efficacy outcomes are expected between SoC arms.

FUNDING:

Pfizer Inc, New York, NY. Plain language summary available for this article.

KEYWORDS:

Blinatumomab; Indirect treatment comparison; Inotuzumab ozogamicin; Matching-adjusted indirect comparison; Relapsed or refractory acute lymphoblastic leukemia; Simulated treatment comparison

PMID:
31140123
DOI:
10.1007/s12325-019-00991-w

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