Evidence map›Paper›PMID 38554156›Full record

ArticleCancer immunology, immunotherapy : CII2024

Ezabenlimab (BI 754091), an anti-PD-1 antibody, in patients with advanced solid tumours.

Manish R Patel, Melissa Johnson, Ira Winer, Hendrik-Tobias Arkenau, Natalie Cook, Vanessa Samouëlian, Raid Aljumaily, Shigehisa Kitano, Christine Duffy, Miaomiao Ge and 2 more

3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 25% 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.

NCT02952248 phase1completednot on this map

An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics, and Efficacy of BI 754091 in Patients With Advanced Solid Tumours

TypeinterventionalSponsorBoehringer IngelheimRan2016 to 2023Enrolled110ConditionsNeoplasmsArmsBI 754091
NCT03433898 early_phase1completednot on this map

An Open Label, Phase I Study of BI 754091 Monotherapy and Combination Therapy of BI 754091 and BI 754111 in Asian Patients With Advanced Solid Tumours

TypeinterventionalSponsorBoehringer IngelheimRan2018 to 2023Enrolled146ConditionsNeoplasmsArmsEzabenlimab, BI 754111
NCT03780725 phase1terminatednot on this map

An Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 754111 in Patients With Advanced Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma Treated With BI 754111 in Combination With BI 754091

TypeinterventionalSponsorBoehringer IngelheimRan2019 to 2020Enrolled8ConditionsCarcinoma, Non-Small-Cell Lung, Head and Neck NeoplasmsArmsBI 754111, [89Zr]Zr-BI 754111, BI 754091
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Review
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

12 authors at 10 institutions in 4 countries.

Manish R PatelSarah Cannon Research Institute, 250 25th Ave N, Nashville, TN, 37203, USA. mpatel@flcancer.com.
Melissa JohnsonSarah Cannon Research Institute, 250 25th Ave N, Nashville, TN, 37203, USA.
Ira WinerWayne State School of Medicine, Karmanos Cancer Institute, Detroit, MI, USA.
Hendrik-Tobias ArkenauSarah Cannon Research Institute, Cancer Institute, University College London, London, UK.
Natalie CookThe Christie NHS Foundation Trust and the University of Manchester, Manchester, UK.
Vanessa SamouëlianCentre Hospitalier de L'Université de Montréal, Montreal, QC, Canada.
Raid AljumailySarah Cannon Research Institute, 250 25th Ave N, Nashville, TN, 37203, USA.
Shigehisa KitanoJapanese Foundation for Cancer Research, Tokyo, Japan.
Christine DuffyBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Miaomiao GeBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Mabrouk ElgadiBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Lillian L SiuPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Boehringer Ingelheim (United States) · USCentre Hospitalier de l’Université de Montréal · CAPrincess Margaret Cancer Centre · CASarah Cannon · USTennessee Oncology · USThe Barbara Ann Karmanos Cancer Institute · USThe Christie NHS Foundation Trust · GBTokyo National Hospital · JPUniversity College London · GBUniversity of Oklahoma · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEzabenlimab (BI 754091) is a humanised monoclonal antibody targeting programmed cell death protein-1. We report results from open-label, dose-escalation/expansion, Phase I trials that evaluated the safety, maximum tolerated dose (MTD), pharmacokinetics and antitumour activity of ezabenlimab at the recommended Phase II dose in patients with selected advanced solid tumours. STUDY

designStudy 1381.1 (NCT02952248) was conducted in Canada, the United Kingdom and the United States. Study 1381.4 (NCT03433898) was conducted in Japan. Study 1381.3 (NCT03780725) was conducted in the Netherlands. The primary endpoints were: number of patients experiencing dose-limiting toxicities (DLTs) in the first cycle (dose escalation parts), number of patients with DLTs during the entire treatment period and objective response (dose expansion part of Study 1381.1).

resultsOverall, 117 patients received ezabenlimab intravenously every 3 weeks (80 mg, n = 3; 240 mg, n = 111; 400 mg, n = 3). No DLTs were observed and the MTD was not reached. Fifty-eight patients (52.3%) had grade ≥ 3 adverse events, most commonly anaemia (10.8%) and fatigue (2.7%). In 111 assessed patients treated with ezabenlimab 240 mg, disease control rate was 56.8% and objective response rate was 16.2%. Three patients had complete response; at data cut-off (November 2021) one remained in response and was still receiving ongoing treatment (duration of response [DoR]: 906 days). Partial responses occurred across several tumour types; DoR ranged from 67 to 757 days.

conclusionsEzabenlimab was well tolerated and associated with durable antitumour activity in multiple solid tumours, comparable to other immune checkpoint inhibitors in similar patient populations and treatment settings.

Indexed as

Immune Checkpoint InhibitorsNeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCanadaHumansAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedImmune Checkpoint InhibitorsAdvanced solid tumoursEzabenlimabPD-1 inhibitorPhase I

Identifiers

PMID38554156
PMCPMC10981579
OpenAlexW4393343265

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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 OpenQuestion graph.