Evidence map›Paper›PMID 39025948›Full record

ArticleNPJ precision oncology2024

Baseline biomarkers of efficacy and on-treatment immune-profile changes associated with bempegaldesleukin plus nivolumab.

Helen Gogas, Shruthi Ravimohan, Antara Datta, Aparna Chhibber, Eva Muñoz Couselo, Adi Diab, Caio Pereira, Gaëlle Quéreux, Shahneen Sandhu, Brendan Curti and 11 more

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

Article in NPJ precision oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03635983 (A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma), 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.

NCT03635983 phase3completednot on this map

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

TypeinterventionalSponsorBristol-Myers SquibbRan2018 to 2024Enrolled783ConditionsMelanomaArmsNKTR-214, Nivolumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. 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

21 authors.

Helen GogasNational and Kapodistrian University of Athens, Athens, Greece. helgogas@gmail.com.ORCID http://orcid.org/0000-0002-0451-2885
Shruthi RavimohanBristol Myers Squibb, Princeton, NJ, USA.
Antara DattaBristol Myers Squibb, Princeton, NJ, USA.
Aparna ChhibberBristol Myers Squibb, Princeton, NJ, USA.
Eva Muñoz CouseloVall d'Hebron Barcelona Hospital and Vall d'Hebron Instituto de Oncología (VHIO), Barcelona, Spain.ORCID http://orcid.org/0000-0001-7556-7608
Adi DiabMD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0001-7368-4798
Caio PereiraFundação Pio XII - Hospital de Câncer de Barretos, São Paulo, Brazil.
Gaëlle QuéreuxUnité Cancéro-Dermatologie, Nantes, France.
Shahneen SandhuPeter MacCallum Cancer Centre, Melbourne, VIC, Australia.
Brendan CurtiEerle A. Chiles Research Institute, Providence Cancer Institute of Oregon, Portland, OR, USA.ORCID http://orcid.org/0000-0003-3948-2708
Nikhil I KhushalaniMoffitt Cancer Center, Tampa, FL, USA.
Matthew H TaylorEerle A. Chiles Research Institute, Providence Cancer Institute of Oregon, Portland, OR, USA.
Gregory A DanielsMoores UCSD Cancer Center, La Jolla, CA, USA.
Anna SpreaficoPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.ORCID http://orcid.org/0000-0002-3034-3042
Tarek MeniawyDepartment of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia.
Alfons J M Van Den EertweghDepartment of Medical Oncology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, the Netherlands.
Yongliang SunBristol Myers Squibb, Princeton, NJ, USA.
Yull ArriagaBristol Myers Squibb, Princeton, NJ, USA.
Ming ZhouBristol Myers Squibb, Princeton, NJ, USA.
Georgina V LongThe Melanoma Institute Australia, The University of Sydney and Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.ORCID http://orcid.org/0000-0001-8894-3545
Céleste LebbéUniversité Paris Cité, Dermato-Oncology and CIC AP-HP Hôpital Saint Louis, Cancer Institute APHP, Nord-Université Paris Cité, Paris, France.ORCID http://orcid.org/0000-0002-5854-7290

Funding

Bristol-Myers Squibb (Bristol-Myers Squibb Company) N/A
6 · The paper itself

Abstract

In PIVOT IO 001 (NCT03635983), the combination of the investigational interleukin-2 agonist bempegaldesleukin (BEMPEG) with nivolumab (NIVO) had no added clinical benefit over NIVO monotherapy in unresectable/metastatic melanoma. Pre-defined baseline and on-treatment changes in selected biomarkers were analyzed to explore the potential mechanisms underlying the clinical observations. In each treatment arm, higher baseline tumor mutational burden or immune infiltration/inflammation was associated with improved efficacy compared with lower levels. On-treatment peripheral biomarker changes showed that BEMPEG + NIVO increased all immune cell subset counts interrogated, including regulatory T cells. This was followed by attenuation of the increase in CD8 + T cells, conventional CD4 + T cells, and systemic interferon gamma levels at later treatment cycles in the combination arm. Changes in tumor biomarkers were comparable between arms. These biomarker results help provide a better understanding of the mechanism of action of BEMPEG + NIVO and may help contextualize the clinical observations from PIVOT IO 001.

Identifiers

PMID39025948
PMCPMC11258232

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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.