Evidence map›Paper›PMID 41688797›Full record

ArticleNPJ precision oncology2026

Clinical validation of a tissue-agnostic genome-wide methylome enrichment assay to monitor response to pembrolizumab.

Eric Y Stutheit-Zhao, Yongqi Zhong, Collin A Melton, Elizabeth D Lightbody, Michael A Hinterberg, Yarong Wang, Owen Hall, Eduardo V Sosa, Jeremy B Provance, Junjun Zhang and 16 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in NPJ precision oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02644369 (Investigator-initiated Phase II Study of Pembrolizumab Immunological Response Evaluation), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT02644369 phase2active not recruitingnot on this map

Investigator-initiated Phase II Study of Pembrolizumab Immunological Response Evaluation

TypeinterventionalSponsorUniversity Health Network, TorontoRan2016 to 2026Enrolled100ConditionsSquamous Cell Cancer of Head and Neck, Triple Negative Breast Cancer, Epithelial Ovarian Cancer, Malignant MelanomaArmsPembrolizumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. 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

26 authors.

Eric Y Stutheit-ZhaoPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Yongqi ZhongAdela, Inc., Foster City, CA, USA.
Collin A MeltonAdela, Inc., Foster City, CA, USA.
Elizabeth D LightbodyAdela, Inc., Foster City, CA, USA.
Michael A HinterbergAdela, Inc., Foster City, CA, USA.
Yarong WangAdela, Inc., Foster City, CA, USA.
Owen HallAdela, Inc., Foster City, CA, USA.
Eduardo V SosaAdela, Inc., Foster City, CA, USA.
Jeremy B ProvanceAdela, Inc., Foster City, CA, USA.
Junjun ZhangAdela, Inc., Foster City, CA, USA.
Abel LiconAdela, Inc., Foster City, CA, USA.
Zhihui Amy LiuPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Albiruni R Abdul RazakPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Anna SpreaficoPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Philippe L BedardPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Aaron R HansenPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Stephanie LheureuxPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Pamela S OhashiPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Alan WilliamsAdela, Inc., Foster City, CA, USA.
Scott V BratmanPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Brian A AllenAdela, Inc., Foster City, CA, USA.
Jing ZhangAdela, Inc., Foster City, CA, USA.
Daniel D De CarvalhoPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Anne-Renee HartmanAdela, Inc., Foster City, CA, USA.
Lillian L SiuPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Enrique Sanz-GarciaPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada. enrique.sanzgarcia@uhn.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Immunotherapy has significantly improved the treatment of metastatic solid tumors; however, detecting early signs of response to enable timely intervention for resistant tumors remains challenging. A blood-only circulating tumor DNA (ctDNA) test may provide a rapid assessment of tumor response without reliance on matched tumor tissue. We applied a tissue-agnostic, genome-wide methylation enrichment assay, based on cell-free methylated DNA immunoprecipitation and high-throughput sequencing (cfMeDIP-seq), to plasma samples from patients in a phase 2 trial evaluating pembrolizumab across multiple solid tumors (NCT02644369). A decrease in ctDNA from baseline to pre-cycle 3 was significantly associated with higher objective response and clinical benefit rates and longer progression-free and overall survival in univariate analyses, with these associations remaining significant in multivariable models except for overall survival. These results validate a commercial-grade, tissue-agnostic plasma cfDNA methylation platform for immunotherapy response monitoring, which may facilitate earlier, more informed treatment decisions and improve patient outcomes.

Identifiers

PMID41688797
PMCPMC13013639

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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.