Evidence map›Paper›PMID 38170160›Full record

Trial reportOncoimmunology2024

A phase 2, multicenter, open-label study of anti-LAG-3 ieramilimab in combination with anti-PD-1 spartalizumab in patients with advanced solid malignancies.

Chia-Chi Lin, Elena Garralda, Patrick Schöffski, David S Hong, Lillian L Siu, Miguel Martin, Michela Maur, Rina Hui, Ross A Soo, Joanne Chiu and 20 more

Open access · goldAbstract readMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Oncoimmunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
5.8field-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.

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

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Emerging new immune checkpoint inhibitors in solid tumor immunotherapy.Naunyn-Schmiedeberg's archives of pharmacology · 2025
    Review
  14. Therapeutic potential of targeting LAG-3 in cancer.Journal for immunotherapy of cancer · 2025
    Review
  15. Exploring new frontiers in LAG-3 biology and therapeutics.Trends in pharmacological sciences · 2025
    Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. 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

30 authors at 20 institutions in 13 countries.

Chia-Chi LinDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
Elena GarraldaVall d'Hebron Institute of Oncology (VHIO), Vall d´Hebron Hospital, Barcelona, Spain.
Patrick SchöffskiDepartment of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.
David S HongDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, University of Texas and MD Anderson Cancer Center, Houston, TX, USA.
Lillian L SiuDivision of Medical Oncology and Hematology, Department of Medicine, Princess Margaret Cancer Center, University Health Network, University of Toronto, Toronto, Canada.
Miguel MartinGregorio Marañón Hospital, Universidad Complutense, Madrid, Spain.
Michela MaurOncology and Haematology Department, Università degli Studi di Modena e Reggio Emilia, Emilia-Romagna, Italy.
Rina HuiDepartment of Medical Oncology, Westmead Hospital and the University of Sydney, Sydney, Australia.
Ross A SooDepartment of Haematology-Oncology, National University Cancer Institute, Singapore.
Joanne ChiuDepartment of Medicine, Queen Mary Hospital, Hong Kong, China.
Tian ZhangDepartment of Medicine, Duke Cancer Institute, Durham, NC, USA.
Brigette MaPhase 1 Clinical Trial Centre, The Chinese University of Hong Kong, Hong Kong, China.
Chrisann KyiDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Daniel Sw TanNational Cancer Centre, Singapore and Duke-NUS Medical School, Singapore.
Philippe A CassierDepartment of Medical Oncology, Centre Léon Bérard, Lyon, France.
John SarantopoulosInstitute for Drug Development, Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cancer Center, San Antonio, TX, USA.
Andrew WeickhardtMedical Oncology Dept, Olivia Newton-John Cancer Centre, Austin Health, Melbourne, Victoria, Australia.
Richard D CarvajalHerbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY, USA.
Jennifer SpratlinCross Cancer Institute, University of Alberta, Edmonton, Canada.
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Fréderic RollandDepartment of Medical Oncology, Institut de Cancérologie de l'Ouest - Centre René Gauducheau, Nantes, France.
Wallace AkerleyHuntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
Barbara Deschler-BaierTranslational Oncology, Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, Würzburg, Germany.
Lawrence RispoliNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Tanay S SamantNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Niladri Roy ChowdhuryNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Daniel GusenleitnerNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Eunice L KwakNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Vasileios AskoxylakisNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Filippo De BraudMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy and Oncology and Hemato-oncology Department, University of Milan, Milan, Italy.
Novartis (United States) · USThe University of Texas MD Anderson Cancer Center · USCentre Léon Bérard · FRChinese University of Hong Kong · HKColumbia University Irving Medical Center · USComprehensive Cancer Center Mainfranken · DEDuke Cancer InstituteDuke-NUS Medical School · SGHospital General Universitario Gregorio Marañón · ESHuntsman Cancer Institute · USInstitut de Cancérologie de l'Ouest · FRKU Leuven · BEMemorial Sloan Kettering Cancer Center · USNational Hospital Organization Kyushu Cancer Center · JPNational Taiwan University Hospital · TWNational University Cancer Institute, Singapore · SGOlivia Newton-John Cancer Wellness & Research Centre · AUPrincess Margaret Cancer Centre · CAQueen Mary Hospital · CNUniversity of Alberta · CA

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Ieramilimab, a humanized anti-LAG-3 monoclonal antibody, was well tolerated in combination with the anti-PD-1 antibody spartalizumab in a phase 1 study. This phase 2 study aimed to further investigate the efficacy and safety of combination treatment in patients with selected advanced (locally advanced or metastatic) solid malignancies. Eligible patients with non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), mesothelioma, and triple-negative breast cancer (TNBC) were grouped depending on prior anti-PD-1/L1 therapy (anti-PD-1/L1 naive or anti-PD-1/L1 pretreated). Patients received ieramilimab (400 mg) followed by spartalizumab (300 mg) every 3 weeks. The primary endpoint was objective response rate (ORR), along with safety, pharmacokinetics, and biomarker assessments. Of 235 patients, 142 were naive to anti-PD-1/L1 and 93 were pretreated with anti-PD-1/L1 antibodies. Durable responses (>24 months) were seen across all indications for patients naive to anti-PD-1/L1 and in melanoma and RCC patients pretreated with anti-PD1/L1. The most frequent study drug-related AEs were pruritus (15.5%), fatigue (10.6%), and rash (10.6%) in patients naive to anti-PD-1/L1 and fatigue (18.3%), rash (14.0%), and nausea (10.8%) in anti-PD-1/L1 pretreated patients. Biomarker assessment indicated higher expression of T-cell-inflamed gene signature at baseline among responding patients. Response to treatment was durable (>24 months) in some patients across all enrolled indications, and safety findings were in accordance with previous and current studies exploring LAG-3/PD-1 blockade.

Indexed as

Carcinoma, Non-Small-Cell LungCarcinoma, Renal CellExanthemaKidney NeoplasmsLung NeoplasmsMelanomaAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiomarkersFatigueHumansImmune Checkpoint InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiomarkersImmune Checkpoint InhibitorsspartalizumabEfficacyieramilimabLAG-3 inhibitorsafetyspartalizumab

Identifiers

PMID38170160
PMCPMC10761073
OpenAlexW4390004386

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.