Evidence map›Paper›PMID 33311588›Full record

ArticleBritish journal of cancer2021

A Phase 1 study of RO6870810, a novel bromodomain and extra-terminal protein inhibitor, in patients with NUT carcinoma, other solid tumours, or diffuse large B-cell lymphoma.

Geoffrey I Shapiro, Patricia LoRusso, Afshin Dowlati, Khanh T Do, Caron A Jacobson, Ulka Vaishampayan, Amy Weise, Paolo F Caimi, Joseph Paul Eder, Christopher A French and 8 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in British journal of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01987362 (A Two-Part, Phase I, Multicenter, Open-Label Study of RO6870810/TEN-010 Given Subcutaneously), which is not on this map. Cited by 72 papers.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed
5.7field-weighted citation impact, top 3% 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.

NCT01987362 phase1completednot on this map

A Two-Part, Phase I, Multicenter, Open-Label Study of RO6870810/TEN-010 Given Subcutaneously: Part A: A Dose-Escalation Study in Patients With Advanced Solid Tumors. Part B: An Expansion Cohort in Patients With Selected Malignancies

TypeinterventionalSponsorHoffmann-La RocheRan2013 to 2017Enrolled52ConditionsSolid Tumors, Advanced Solid TumorsArmsRO6870810
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 116 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Shared PRAME epitopes are T-cell targets in NUT carcinoma.Journal for immunotherapy of cancer · 2026
    Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Targeting lysine acetylation readers and writers.Nature reviews. Drug discovery · 2025
    Review
  18. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
    Review
  19. Review
  20. Article

12 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

18 authors at 6 institutions in 2 countries.

Geoffrey I ShapiroDepartment of Medical Oncology, Dana-Farber Cancer Institute, and Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. geoffrey_shapiro@dfci.harvard.edu.ORCID http://orcid.org/0000-0002-3331-4095
Patricia LoRussoEarly Phase Clinical Trials Program, Yale University Medical Center, New Haven, CT, USA.
Afshin DowlatiDepartment of Medicine-Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, OH, USA.
Khanh T DoDepartment of Medical Oncology, Dana-Farber Cancer Institute, and Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Caron A JacobsonDepartment of Medical Oncology, Dana-Farber Cancer Institute, and Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Ulka VaishampayanDepartment of Oncology, Karmanos Cancer Institute, Detroit, MI, USA.
Amy WeiseMedical Oncology, Karmanos Cancer Institute, Detroit, MI, USA.
Paolo F CaimiDepartment of Medicine-Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, OH, USA.
Joseph Paul EderEarly Phase Clinical Trials Program, Yale University Medical Center, New Haven, CT, USA.
Christopher A FrenchDepartment of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Emily Labriola-TompkinsRoche Pharma Research and Early Development, Roche Innovation Center New York, New York, NY, USA.
Frédéric BoisserieRoche Pharma Research and Early Development, Roche Innovation Center New York, New York, NY, USA.
William E PierceallRoche Pharma Research and Early Development, Roche Innovation Center New York, New York, NY, USA.
Jianguo ZhiRoche Pharma Research and Early Development, Roche Innovation Center New York, New York, NY, USA.
Sharon PasseRoche Pharma Research and Early Development, Roche Innovation Center New York, New York, NY, USA.
Mark DeMarioRoche Pharma Research and Early Development, Roche Innovation Center New York, New York, NY, USA.
Martin KornackerRoche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Philippe ArmandDepartment of Medical Oncology, Dana-Farber Cancer Institute, and Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
La Roche College · USBrigham and Women's Hospital · USThe Barbara Ann Karmanos Cancer Institute · USUniversity Hospitals Seidman Cancer Center · USYale Cancer Center · USRoche (Switzerland) · CH

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundBromodomain and extra-terminal (BET) proteins are epigenetic readers that can drive carcinogenesis and therapy resistance. RO6870810 is a novel, small-molecule BET inhibitor.

methodsWe conducted a Phase 1 study of RO6870810 administered subcutaneously for 21 or 14 days of 28- or 21-day cycles, respectively, in patients with the nuclear protein of the testis carcinoma (NC), other solid tumours, or diffuse large B-cell lymphoma (DLBCL) with MYC deregulation.

resultsFatigue (42%), decreased appetite (35%) and injection-site erythema (35%) were the most common treatment-related adverse events. Pharmacokinetic parameters demonstrated linearity over the dose range tested and support once-daily dosing. Pharmacodynamic assessments demonstrated sustained decreases in CD11b levels in peripheral blood mononuclear cells. Objective response rates were 25% (2/8), 2% (1/47) and 11% (2/19) for patients with NC, other solid tumours and DLBCL, respectively. Responding tumours had evidence of deregulated MYC expression.

conclusionsThis trial establishes the safety, favourable pharmacokinetics, evidence of target engagement and preliminary single-agent activity of RO6870810. Responses in patients with NC, other solid tumours and DLBCL provide proof-of-principle for BET inhibition in MYC-driven cancers. The results support further exploration of RO6870810 as monotherapy and in combinations. CLINICAL TRIALS REGISTRATION: NCT01987362.

Indexed as

AdultAgedAged, 80 and overAzepinesBromodomain Containing ProteinsDose-Response Relationship, DrugFemaleHumansLymphoma, Large B-Cell, DiffuseMaleMiddle AgedNeoplasm ProteinsNeoplasmsNuclear ProteinsProteinsSmall Molecule LibrariesAzepinesbromodomain and extra-terminal domain protein, humanBromodomain Containing ProteinsNeoplasm ProteinsNuclear ProteinsNUTM1 protein, humanProteinsSmall Molecule Libraries

Identifiers

PMID33311588
PMCPMC7884382
OpenAlexW3111329327

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.