Evidence map›Paper›PMID 37689979›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

HERTHENA-Lung01, a Phase II Trial of Patritumab Deruxtecan (HER3-DXd) in Epidermal Growth Factor Receptor-Mutated Non-Small-Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Platinum-Based Chemotherapy.

Helena A Yu, Yasushi Goto, Hidetoshi Hayashi, Enriqueta Felip, James Chih-Hsin Yang, Martin Reck, Kiyotaka Yoh, Se-Hoon Lee, Luis Paz-Ares, Benjamin Besse and 19 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04619004 (HERTHENA-Lung01), which is not on this map. Cited by 160 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
160citing papers in PubMed, 8 pooled it
52.5field-weighted citation impact, top 1% 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.

NCT04619004 phase2active not recruitingnot on this map

HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorDaiichi SankyoRan2021 to 2027Enrolled277ConditionsNon-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor ReceptorArmsPatritumab Deruxtecan (Fixed dose), Patritumab Deruxtecan (Up-Titration)
3 · Its place in the literature

Who cites it

160 citing papers in PubMed, 8 syntheses or guidelines pooled it, 205 citations in OpenAlex.

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  6. [Clinical Progress and Prospects of Antibody-drug Conjugates in Advanced NSCLC].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025
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  9. Phase 2 Study of Amivantamab Plus Lazertinib in Previously Treated Patients With EGFR-Mutant Lung Cancers With Brain and Leptomeningeal Metastases.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026
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  16. Efficacy and safety of third-generationTranslational lung cancer research · 2026
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100 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 20 institutions in 11 countries.

Helena A YuDepartment of Medicine, Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-0377-9510
Yasushi GotoNational Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-7437-5054
Hidetoshi HayashiKindai University, Osaka, Japan.ORCID 0000-0001-8787-5587
Enriqueta FelipVall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.ORCID 0000-0002-7620-0098
James Chih-Hsin YangNational Taiwan University Hospital, Taipei City, Taiwan.ORCID 0000-0002-5586-5138
Martin ReckDepartment of Thoracic Oncology, Airway Research Center North, German Center for Lung Research, LungenClinic Grosshansdorf, Grosshansdorf, Germany.ORCID 0000-0002-5336-9739
Kiyotaka YohNational Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0001-6928-357X
Se-Hoon LeeSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.ORCID 0000-0002-9219-3350
Luis Paz-AresHospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and CIBERONC, Madrid, Spain.ORCID 0000-0002-1947-3364
Benjamin BesseGustave Roussy, Université Paris-Saclay, Villejuif, France.ORCID 0000-0001-5090-8189
Paolo BironzoDepartment of Oncology, University of Torino, Torino, Italy.ORCID 0000-0002-2784-5076
Dong-Wan KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.ORCID 0000-0001-5124-7132
Melissa L JohnsonTennessee Oncology, Sarah Cannon Research Institute, Nashville, TN.ORCID 0000-0001-9874-1314
Yi-Long WuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Southern Medical University, Guangzhou, China.ORCID 0000-0002-3611-0258
Thomas JohnDepartment of Medical Oncology, Peter MacCallum Cancer Centre, University of Melbourne, Parkville, VIC, Australia.ORCID 0000-0003-3399-5342
Steven KaoChris O'Brien Lifehouse, Sydney, NSW, Australia.
Toshiyuki KozukiNational Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Erminia MassarelliDepartment of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, CA.ORCID 0000-0001-7798-7286
Jyoti PatelDivision of Hematology and Oncology, Department of Medicine, Northwestern University, Chicago, IL.ORCID 0000-0002-7550-2094
Egbert SmitNetherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.ORCID 0000-0002-7329-6995
Karen L ReckampDepartment of Medicine, Cedars Sinai Medical Center, Los Angeles, CA.ORCID 0000-0002-9213-0325
Qian DongDaiichi Sankyo, Inc, Basking Ridge, NJ.
Pomy ShresthaDaiichi Sankyo, Inc, Basking Ridge, NJ.
Pang-Dian FanDaiichi Sankyo, Inc, Basking Ridge, NJ.ORCID 0000-0002-7968-7516
Parul PatelDaiichi Sankyo, Inc, Basking Ridge, NJ.
Andrea SporchiaDaiichi Sankyo, Inc, Basking Ridge, NJ.
David W SternbergDaiichi Sankyo, Inc, Basking Ridge, NJ.
Dalila SellamiDaiichi Sankyo, Inc, Basking Ridge, NJ.
Pasi A JänneLowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-7821-4928
Daiichi Sankyo (United States) · USCedars-Sinai Medical Center · USCentro de Investigación del Cáncer · ESChris O’Brien Lifehouse · AUCity Of Hope National Medical Center · USDana-Farber Cancer Institute · USGerman Center for Lung Research · DEGuangdong Provincial People's Hospital · CNKindai University · JPMemorial Sloan Kettering Cancer Center · USNational Cancer Center Hospital East · JPNational Taiwan University Hospital · TWNorthwestern University · USSamsung Medical Center · KRSarah Cannon · USSeoul National University Hospital · KRShikoku Cancer Center · JPThe Netherlands Cancer Institute · NLThe University of Melbourne · AUTokyo National Hospital · JP

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

purposePatritumab deruxtecan, or HER3-DXd, is an antibody-drug conjugate consisting of a fully human monoclonal antibody to human epidermal growth factor receptor 3 (HER3) attached to a topoisomerase I inhibitor payload via a stable tetrapeptide-based cleavable linker. We assessed the efficacy and safety of HER3-DXd in patients with epidermal growth factor receptor (

methodsThis phase II study (ClinicalTrials.gov identifier: NCT04619004) was designed to evaluate HER3-DXd in patients with advanced

resultsEnrollment into the uptitration arm closed early on the basis of a prespecified benefit-risk assessment of data from the phase I U31402-A-U102 trial. In total, 225 patients received HER3-DXd 5.6 mg/kg once every 3 weeks. As of May 18, 2023, median study duration was 18.9 (range, 14.9-27.5) months. Confirmed ORR by BICR was 29.8% (95% CI, 23.9 to 36.2); median duration of response, 6.4 months; median progression-free survival, 5.5 months; and median overall survival, 11.9 months. The subgroup of patients with previous osimertinib and PBC had similar outcomes. Efficacy was observed across a broad range of pretreatment tumor HER3 membrane expression levels and across diverse mechanisms of EGFR TKI resistance. In patients with nonirradiated brain metastases at baseline (n = 30), the confirmed CNS ORR by BICR per CNS RECIST was 33.3% (95% CI, 17.3 to 52.8). The safety profile (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) was manageable and tolerable, consistent with previous observations.

conclusionAfter tumor progression with EGFR TKI therapy and PBC in patients with

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, Monoclonal, HumanizedCamptothecinErbB ReceptorsHumansMutationPlatinumProtein Kinase InhibitorsAntibodies, Monoclonal, HumanizedCamptothecinErbB Receptorspatritumab deruxtecanPlatinumProtein Kinase Inhibitors

Identifiers

PMID37689979
PMCPMC10713116
OpenAlexW4386582468

What OpenQuestion holds

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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.