Indirect Treatment Comparison of Inotuzumab Ozogamicin Versus Blinatumomab for Relapsed or Refractory Acute Lymphoblastic Leukemia.
Adolescent
Adult
Aged
Antibodies, Bispecific
/ therapeutic use
Antineoplastic Agents
/ therapeutic use
Antineoplastic Agents, Immunological
/ therapeutic use
Disease-Free Survival
Female
Humans
Inotuzumab Ozogamicin
/ therapeutic use
Male
Middle Aged
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
/ drug therapy
Remission Induction
Standard of Care
Young Adult
Blinatumomab
Indirect treatment comparison
Inotuzumab ozogamicin
Matching-adjusted indirect comparison
Relapsed or refractory acute lymphoblastic leukemia
Simulated treatment comparison
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
03
04
2019
pubmed:
30
5
2019
medline:
11
6
2020
entrez:
30
5
2019
Statut:
ppublish
Résumé
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. 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. 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. 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. Pfizer Inc, New York, NY. Plain language summary available for this article.
Identifiants
pubmed: 31140123
doi: 10.1007/s12325-019-00991-w
pii: 10.1007/s12325-019-00991-w
pmc: PMC6822860
doi:
Substances chimiques
Antibodies, Bispecific
0
Antineoplastic Agents
0
Antineoplastic Agents, Immunological
0
blinatumomab
4FR53SIF3A
Inotuzumab Ozogamicin
P93RUU11P7
Banques de données
figshare
['10.6084/m9.figshare.8109149']
Types de publication
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
2147-2160Commentaires et corrections
Type : CommentIn
Type : CommentIn
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