Evidence map›Paper›PMID 41272153›Full record

ArticleNPJ precision oncology2025

A signal-seeking phase 2 study of tremelimumab in advanced cancers with high tumour mutational burden.

Subotheni Thavaneswaran, Frank Lin, David Espinoza, John Grady, Peey-Sei Kok, Sarah Chinchen, Nick Pavlakis, Vladimir Andelkovic, Michail Charakidis, Paul Craft and 6 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in NPJ precision oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. Article
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

16 authors.

Subotheni ThavaneswaranNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia. s.thavaneswaran@garvan.org.au.
Frank LinNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
David EspinozaNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
John GradyCentre for Molecular Oncology, University of NSW, Sydney, NSW, Australia.
Peey-Sei KokNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Sarah ChinchenNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Nick PavlakisRoyal North Shore Hospital, Sydney, NSW, Australia.
Vladimir AndelkovicPrincess Alexandra Hospital, Brisbane, QLD, Australia.
Michail CharakidisRoyal Darwin Hospital, Darwin, NT, Australia.
Paul CraftThe Canberra Hospital, Canberra, ACT, Australia.
Michael BrownRoyal Adelaide Hospital, Adelaide, SA, Australia.
Jayesh DesaiPeter MacCallum Cancer Centre, Melbourne, VIC, Australia.
Peter LauHarry Perkins Institute of Medical Research, Nedlands, WA, Australia.
Maya KansaraCentre for Molecular Oncology, University of NSW, Sydney, NSW, Australia.
John SimesNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
David ThomasCentre for Molecular Oncology, University of NSW, Sydney, NSW, Australia. dmthomas@unsw.edu.au.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This single-arm phase II trial (ACTRN12620000918921) evaluated the clinical activity of tremelimumab (10 mg/kg intravenously every 4 weeks for 6 cycles) in advanced cancers with a high tumour mutational burden (TMB), defined as TMB > 10 mutations/megabase (mut/Mb) on standard platforms (TSO500 panel, F1CDx), or >20 mut/Mb on the TST170 panel. The primary objective was 6-month progression-free survival rate (PFS6) by iRECIST. Secondary objectives included objective response; the ratio of time to progression (TTP) on study to TTP on prior therapy (TTP2:TTP1); overall survival (OS); and safety. After minimum followup of 12 months, the PFS6 was 6% (95% CI 0-24%), with a median PFS and OS of 1.9 (95% CI 1.4-2.8) and 6.3 (2.8-10.3) months, respectively. Amongst 19 evaluable patients, two partial responses occurred in an endometrial adenocarcinoma and an undifferentiated pleomorphic sarcoma, maintained for 3.8 and 15.9 months respectively, both with TMB >20 mut/Mb. Adverse events were experienced by 19 patients (90%), with 15 patients (72%) experiencing grade 3-5 adverse events. Seven tremelimumab-related serious adverse events (grade 2-3) occurred in 5 patients. While the primary PFS6 endpoint was not met, there were two durable objective responses in rare cancers and a favourable change in disease trajectory for an additional five patients based on TTP ratio

Identifiers

PMID41272153
PMCPMC12639129

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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.