Evidence map›Paper›PMID 30920645›Full record

Trial reportCancer2019

Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: Final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study.

Hagop M Kantarjian, Daniel J DeAngelo, Matthias Stelljes, Michaela Liedtke, Wendy Stock, Nicola Gökbuget, Susan M O'Brien, Elias Jabbour, Tao Wang, Jane Liang White and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 195 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
195citing papers in PubMed, 8 pooled it
35.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

195 citing papers in PubMed, 8 syntheses or guidelines pooled it, 318 citations in OpenAlex.

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  9. Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
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135 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 2 countries.

Hagop M KantarjianThe University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1908-3307
Daniel J DeAngeloDana-Farber Cancer Institute, Boston, Massachusetts.
Matthias StelljesUniversity Hospital Münster, Münster, Germany.
Michaela LiedtkeStanford Cancer Institute, Stanford, California.
Wendy StockUniversity of Chicago, Chicago, Illinois.
Nicola GökbugetGoethe University, Frankfurt, Germany.
Susan M O'BrienIrvine Medical Center, University of California, Orange, California.
Elias JabbourThe University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-4465-6119
Tao WangPfizer Inc, Groton, Connecticut.
Jane Liang WhitePfizer Inc, Groton, Connecticut.
Barbara SleightPfizer Inc, Groton, Connecticut.
Erik VandendriesPfizer Inc, Cambridge, Massachusetts.
Anjali S AdvaniTaussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.
Pfizer (United States) · USThe University of Texas MD Anderson Cancer Center · USCancer Prevention Institute of California · USCleveland Clinic · USDana-Farber Cancer Institute · USGoethe University Frankfurt · DEUniversity Hospital Münster · DEUniversity of California, Irvine · USUniversity of Chicago · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundInotuzumab ozogamicin (InO) is an antibody-drug conjugate used for adults with relapsed/refractory B-cell precursor (BCP) acute lymphoblastic leukemia (ALL). The INotuzumab Ozogamicin trial to inVestigAte Tolerability and Efficacy (INO-VATE) previously reported improved outcomes with InO versus standard-of-care (SoC) chemotherapy. This article reports the final INO-VATE results (≥2 years of follow-up) and additional analyses of patient characteristics associated with improved outcomes.

methodsBetween August 27, 2012, and January 4, 2015, this multicenter, parallel, open-label, phase 3 trial randomized 326 adults with relapsed/refractory ALL to InO (n = 164) or SoC (n = 162); 307 received 1 or more doses of the study drug (164 in the InO arm and 143 in the SoC arm).

resultsThe complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) rate was higher with InO versus SoC (73.8% vs 30.9%; 1-sided P < .0001), with consistent CR/CRi rates across patient subgroups. The median overall survival (OS) was 7.7 months with InO and 6.2 months with SoC, with 2-year OS rates of 22.8% and 10.0%, respectively (overall hazard ratio, 0.75; 97.5% confidence interval [CI], 0.57-0.99; 1-sided P = .0105). The predictors of OS with InO were the best minimal residual disease status, baseline platelet count, duration of first remission, achievement of CR/CRi, and follow-up hematopoietic stem cell transplantation (HSCT; all 2-sided P values < .05). More InO arm patients proceeded directly to HSCT after achieving CR/CRi before any follow-up induction therapy (39.6% [95% CI, 32.1%-47.6%] vs 10.5% [6.2%-16.3%]; 1-sided P < .0001). The most frequent all-grade and grade 3 or higher adverse events in both arms were hematologic. Veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) was more frequent with InO (23 of 164 [14.0%] vs 3 of 143 [2.1%]).

conclusionsIn patients with relapsed/refractory BCP ALL in INO-VATE, InO was associated with a greater likelihood of CR/CRi across key patient subgroups, and it served as a bridge to HSCT. Potential VOD/SOS risk factors must be considered when InO treatment decisions are being made.

Indexed as

Standard of CareAdolescentAdultAgedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsDrug Resistance, NeoplasmFemaleFollow-Up StudiesHepatic Veno-Occlusive DiseaseHumansInotuzumab OzogamicinMaleMiddle AgedPrecursor B-Cell Lymphoblastic Leukemia-LymphomaProgression-Free SurvivalAntineoplastic Agents, ImmunologicalInotuzumab Ozogamicinacute lymphoblastic leukemiaadultshematopoietic stem cell transplantationhepatic veno-occlusive diseaseinotuzumab ozogamicinremission induction

Identifiers

PMID30920645
PMCPMC6618133
OpenAlexW2931981435

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.