Evidence map›Paper›PMID 40068370›Full record

ArticleEuropean journal of cancer (Oxford, England : 1990)2025

Efficacy and safety of larotrectinib in patients with TRK fusion gastrointestinal cancer.

Changsong Qi, Lin Shen, Thierry Andre, Hyun Cheol Chung, Timothy L Cannon, Elena Garralda, Antoine Italiano, Damian T Rieke, Tianshu Liu, Domnita-Ileana Burcoveanu and 6 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in European journal of cancer (Oxford, England : 1990), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02576431 (A Study to Learn How Well the Drug Larotrectinib Works in Adults With Different Solid Cancers With a Change in the Genes Called NTRK Fusion), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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.

NCT02576431 phase2completednot on this map

A Study to Learn How Well the Drug Larotrectinib Works in Adults With Different Solid Cancers With a Change in the Genes Called NTRK Fusion

TypeinterventionalSponsorBayerRan2015 to 2025Enrolled215ConditionsSolid Tumors Harboring NTRK FusionArmsBAY2757556 (Larotrectinib, Vitrakvi)
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

  1. Review
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  9. Review
  10. Rare, Yet Targetable: New Perspectives on Ampullary Carcinomas.International journal of molecular sciences · 2026
    Review
  11. Article
  12. Article
  13. Review
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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.

Changsong QiState Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Peking University Cancer Hospital & Institute, Beijing, China. Electronic address: changsongqi@bjmu.edu.cn.
Lin ShenState Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Peking University Cancer Hospital & Institute, Beijing, China.
Thierry AndreSorbonne Université and St Antoine Hospital, Paris, France.
Hyun Cheol ChungYonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Timothy L CannonInova Schar Cancer Institute, Inova Fairfax Hospital, Fairfax, VA, USA.
Elena GarraldaEarly Drug Development Unit, Vall d´Hebron Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Antoine ItalianoEarly Phase Trials Unit, Institut Bergonie, Bordeaux, France; University of Bordeaux, Bordeaux, France.
Damian T RiekeCharité - Universitätsmedizin Berlin, Berlin, Germany.
Tianshu LiuZhongshan Hospital-Fudan University, Shanghai, China.
Domnita-Ileana BurcoveanuBayer HealthCare Pharmaceuticals, Inc., Basel, Switzerland.
Natascha NeuChrestos Concept GmbH & Co. KG, Essen, Germany.
Chiara E MussiBayer S.p.A., Milan, Italy.
Rui-Hua XuSun Yat-sen University Cancer Center, Guangzhou, China.
David S HongThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Alexander DrilonMemorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA.
Jordan BerlinVanderbilt University Medical Center, Nashville, TN, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
Understanding tumor addiction to TRK fusions and sensitivity to TRK inhibitionR01CA226864 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI DRILON, ALEXANDER, VENTURA, ANDREA · 2018 to 2021
$2.5M
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA226864
6 · The paper itself

Abstract

backgroundLarotrectinib is the first-in-class, highly selective TRK inhibitor with demonstrated efficacy in various TRK fusion solid tumours. We report the efficacy and safety of larotrectinib in patients with TRK fusion gastrointestinal (GI) cancer.

methodsPatients with TRK fusion GI cancer from NAVIGATE (NCT02576431) were included. Response was independent review committee (IRC)-assessed per RECIST v1.1.

resultsAs of July 2023, 44 patients were enrolled. Tumour types included colorectal (CRC; n = 26), pancreatic (n = 7), cholangiocarcinoma (n = 4), gastric (n = 3), and one each of appendiceal, duodenal, oesophageal and hepatic cancers. Of the 26 patients with CRC, 16 (62 %) had known microsatellite instability-high (MSI-H) status. For the 43 IRC-eligible patients, overall response rate was 28 % (95 % confidence interval [CI] 15-44) for all patients and 44 % (95 % CI 24-65) for those with CRC. In patients overall and in those with CRC, median duration of response was 27 months (95 % CI 6-not estimable [NE]) and 27 months (95 % CI 6-NE), median progression-free survival was 6 months (95 % CI 5-9) and 7 months (95 % CI 6-NE), and median overall survival was 13 months (95 % CI 7-29) and 29 months (95 % CI 7-NE), respectively. Grade 3/4 treatment-related adverse events (TRAEs) occurred in seven (16 %) patients. There were no deaths due to TRAEs.

conclusionLarotrectinib demonstrated long durability, extended survival and manageable safety in patients with TRK fusion GI cancer, including those with MSI-H CRC. This supports the wider adoption of next-generation sequencing testing for NTRK gene fusions in patients with GI cancer.

Indexed as

Gastrointestinal NeoplasmsOncogene Proteins, FusionProtein Kinase InhibitorsPyrazolesPyrimidinesReceptor, trkAAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedReceptor, trkCTreatment OutcomelarotrectinibOncogene Proteins, FusionProtein Kinase InhibitorsPyrazolesPyrimidinesReceptor, trkAReceptor, trkCColorectal cancerGastrointestinal cancerLarotrectinibNTRK gene fusionTRK fusion

Identifiers

PMID40068370
PMCPMC12517377

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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.