Evidence map›Paper›PMID 38844408›Full record

Trial reportJournal for immunotherapy of cancer2024

Long-term survival follow-up for tebentafusp in previously treated metastatic uveal melanoma.

Joseph J Sacco, Richard D Carvajal, Marcus O Butler, Alexander N Shoushtari, Jessica C Hassel, Alexandra Ikeguchi, Leonel Hernandez-Aya, Paul Nathan, Omid Hamid, Josep M Piulats and 8 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
–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

27 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Incidence and Management of Adverse Events Associated with Tebentafusp Treatment in Metastatic Uveal Melanoma: Pooled Safety Analysis of 410 Patients.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
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  18. Review
  19. Facts and Hopes: Toward the Next Quantum Leap in Melanoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Review
  20. 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

18 authors.

Joseph J SaccoClatterbridge Cancer Centre NHS Foundation Trust, Wirral, UK joseph.sacco@nhs.net Takami.Sato@jefferson.edu.ORCID http://orcid.org/0000-0003-2591-9796
Richard D CarvajalNorthwell Health Cancer Institute, New York, New York, USA.
Marcus O ButlerPrincess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.
Alexander N ShoushtariMemorial Sloan Kettering Cancer Center, New York, New York, USA.ORCID http://orcid.org/0000-0002-8065-4412
Jessica C HasselUniversity Hospital Heidelberg, Heidelberg, Germany.ORCID http://orcid.org/0000-0001-7575-6230
Alexandra IkeguchiThe University of Oklahoma Stephenson Cancer Center, Oklahoma City, Oklahoma, USA.
Leonel Hernandez-AyaUniversity of Miami Miller School of Medicine, Miami, Florida, USA.
Paul NathanMount Vernon Cancer Centre, Northwood, Middlesex, UK.
Omid HamidThe Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, Santa Monica, California, USA.
Josep M PiulatsCatalan Cancer Institute (ICO) de l'Hospitalet - ProCure Program, Barcelona, Spain.
Matthew RiothUC Cancer Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
Douglas B JohnsonVanderbilt University Medical Center, Nashville, Tennessee, USA.
Jason J LukeUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.ORCID http://orcid.org/0000-0002-1182-4908
Enrique EspinosaHospital Universitario La Paz, Madrid, Spain.
Serge LeyvrazCharité Comprehensive Cancer Center, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Laura CollinsImmunocore, Abingdon-on-Thames, Oxfordshire, UK.
Chris HollandImmunocore, Rockville, Maryland, USA.
Takami SatoSidney Kimmel Cancer Center, Philadelphia, Pennsylvania, USA joseph.sacco@nhs.net Takami.Sato@jefferson.edu.

Funding

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

Abstract

backgroundTebentafusp, a bispecific (gp100×CD3) ImmTAC, significantly improved overall survival (OS) outcomes for HLA-A*02:01+ adult patients with untreated metastatic uveal melanoma (mUM) and showed promising survival in previously treated mUM with 1-year OS of 62% in the primary analysis of study IMCgp100-102. Here we report long-term outcomes from this phase 1/2 study in pretreated mUM. PATIENTS AND

methodsPatients with previously treated mUM received tebentafusp weekly intravenous at 20 µg dose 1, 30 µg dose 2 and either 54, 64, 68, or 73 µg (phase 1) or 68 µg (phase 2) dose 3+. The primary objective was overall response rate. Secondary objectives included OS and safety. OS was estimated by Kaplan-Meier methods. Association between OS and baseline covariates, on-treatment Response Evaluation Criteria in Solid Tumors (RECIST) response, baseline tumor biopsy and circulating-tumor DNA (ctDNA) changes were assessed.

results146 patients were treated with tebentafusp: 19 in phase 1 and 127 in phase 2. With a median follow-up duration of 48.5 months, the median OS was 17.4 months (95% CI, 13.1 to 22.8), and the 1-year, 2-year, 3-year and 4-year OS rates were 62%, 40%, 23% and 14%, respectively. Improved survival was associated with lower ctDNA baseline levels and greater ctDNA reductions by week 9 on-treatment, with 100% 1-year, 73% 2-year and 45% 3-year OS rates for patients with ctDNA clearance. Baseline gp100 expression was not associated with survival, despite more RECIST responses among patients with higher expression. No new safety signals were reported with long-term dosing.

conclusionsThis study represents the longest follow-up of a Tcell receptor bispecific to date and confirms the durable survival benefits achieved with tebentafusp in previously treated mUM with good tolerability long-term. A role for ctDNA reduction as an early indicator of clinical benefit was again suggested for patients treated with tebentafusp.

Indexed as

MelanomaUveal NeoplasmsAdultAgedAged, 80 and overAntibodies, BispecificFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm MetastasisUveal MelanomaAntibodies, Bispecificbispecific T cell engager - BiTEcirculating tumor DNA - ctDNAimmunotherapysolid tumorT cell receptor - TCR

Identifiers

PMID38844408
PMCPMC11163599

What OpenQuestion holds

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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.