Evidence map›Paper›PMID 35444060›Full record

ReviewJournal for immunotherapy of cancer2022

Immunogenicity assessment of bispecific antibody-based immunotherapy in oncology.

Yanchen Zhou, Hweixian L Penny, Mark A Kroenke, Bianca Bautista, Kelly Hainline, Lynette S Chea, Jane Parnes, Daniel T Mytych

Open access · goldAbstract readReview
In one paragraph

Review in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 1 pooled it
6.4field-weighted citation impact, top 2% 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

54 citing papers in PubMed, 1 synthesis or guideline pooled it, 78 citations in OpenAlex.

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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

8 authors at 1 institution in 1 country.

Yanchen ZhouClinical Immunology, Amgen Inc, South San Francisco, California, USA yanchenz@amgen.com.
Hweixian L PennyClinical Immunology, Amgen Inc, Thousand Oaks, California, USA.
Mark A KroenkeClinical Immunology, Amgen Inc, Thousand Oaks, California, USA.
Bianca BautistaClinical Immunology, Amgen Inc, Thousand Oaks, California, USA.
Kelly HainlineClinical Immunology, Amgen Inc, Thousand Oaks, California, USA.
Lynette S CheaClinical Immunology, Amgen Inc, South San Francisco, California, USA.
Jane ParnesEarly Development, Amgen Inc, Thousand Oaks, California, USA.
Daniel T MytychClinical Immunology, Amgen Inc, Thousand Oaks, California, USA.
Amgen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

With increasing numbers of bispecific antibodies (BsAbs) and multispecific products entering the clinic, recent data highlight immunogenicity as an emerging challenge in the development of such novel biologics. This review focuses on the immunogenicity risk assessment (IgRA) of BsAb-based immunotherapies for cancer, highlighting several risk factors that need to be considered. These include the novel scaffolds consisting of bioengineered sequences, the potentially synergistic immunomodulating mechanisms of action (MOAs) from different domains of the BsAb, as well as several other product-related and patient-related factors. In addition, the clinical relevance of anti-drug antibodies (ADAs) against selected BsAbs developed as anticancer agents is reviewed and the advances in our knowledge of tools and strategies for immunogenicity prediction, monitoring, and mitigation are discussed. It is critical to implement a drug-specific IgRA during the early development stage to guide ADA monitoring and risk management strategies. This IgRA may include a combination of several assessment tools to identify drug-specific risks as well as a proactive risk mitigation approach for candidate or format selection during the preclinical stage. The IgRA is an on-going process throughout clinical development. IgRA during the clinical stage may bridge the gap between preclinical immunogenicity prediction and clinical immunogenicity, and retrospectively guide optimization efforts for next-generation BsAbs. This iterative process throughout development may improve the reliability of the IgRA and enable the implementation of effective risk mitigation strategies, laying the foundation for improved clinical success.

Indexed as

Antibodies, BispecificHumansImmunologic FactorsImmunotherapyReproducibility of ResultsRetrospective StudiesAntibodies, BispecificImmunologic Factorsanti-drug antibodiesbispecific antibodyimmunogenicityimmunotherapyoncologyT-cell engager

Identifiers

PMID35444060
PMCPMC9024276
OpenAlexW4224223335

What OpenQuestion 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 OpenQuestion graph.