Evidence map›Paper›PMID 38940019›Full record

ArticleCancer communications (London, England)2024

Disitamab vedotin, a HER2-directed antibody-drug conjugate, in patients with HER2-overexpression and HER2-low advanced breast cancer: a phase I/Ib study.

Jiayu Wang, Yunjiang Liu, Qingyuan Zhang, Wei Li, Jifeng Feng, Xiaojia Wang, Jianmin Fang, Yiqun Han, Binghe Xu

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer communications (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07201675 (Vedisertib), which is not on this map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 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.

NCT07201675 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Vedisertib (RC48/ADC) Combined With Toripalimab in Bladder-preserving Treatment

TypeinterventionalSponsorQilu Hospital of Shandong UniversityRan2025 to 2027Enrolled59ConditionsMuscle Invasive Bladder Cancer (MIBC)ArmsRC48-ADC combined with toripalimab for bladder-sparing therapy
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

9 authors.

Jiayu WangDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Yunjiang LiuBreast Center, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, P. R. China.
Qingyuan ZhangDepartment of Breast Medicine, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, P. R. China.
Wei LiDepartment of Medical Oncology, The First Hospital of Jilin University, Changchun, Jilin, P. R. China.
Jifeng FengDepartment of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, Jiangsu, P. R. China.
Xiaojia WangDepartment of Breast Medicine, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, P. R. China.
Jianmin FangSchool of Life Science and Technology, Tongji University, Shanghai, P. R. China.
Yiqun HanDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Binghe XuDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.

Funding

CAMS Innovation Fund for Medical Sciences (CIFMS) 2021-I2M-1-014RemeGen Co., Ltd
6 · The paper itself

Abstract

backgroundDisitamab vedotin (DV; RC48-ADC) is an antibody-drug conjugate comprising a human epidermal growth factor receptor 2 (HER2)-directed antibody, linker and monomethyl auristatin E. Preclinical studies have shown that DV demonstrated potent antitumor activity in preclinical models of breast, gastric, and ovarian cancers with different levels of HER2 expression. In this pooled analysis, we report the safety and efficacy of DV in patients with HER2-overexpression and HER2-low advanced breast cancer (ABC).

methodsIn the phase I dose-escalation study (C001 CANCER), HER2-overexpression ABC patients received DV at doses of 0.5-2.5 mg/kg once every two weeks (Q2W) until unacceptable toxicity or progressive disease. The dose range, safety, and pharmacokinetics (PK) were determined. The phase Ib dose-range and expansion study (C003 CANCER) enrolled two cohorts: HER2-overexpression ABC patients receiving DV at doses of 1.5-2.5 mg/kg Q2W, with the recommended phase 2 dose (RP2D) determined, and HER2-low ABC patients receiving DV at doses of 2.0 mg/kg Q2W to explore the efficacy and safety of DV in HER2-low ABC.

resultsTwenty-four patients with HER2-overexpression ABC in C001 CANCER, 46 patients with HER2-overexpression ABC and 66 patients with HER2-low ABC in C003 CANCER were enrolled. At 2.0 mg/kg RP2D Q2W, the confirmed objective response rates were 42.9% (9/21; 95% confidence interval [CI]: 21.8%-66.0%) and 33.3% (22/66; 95% CI: 22.2%-46.0%), with median progression-free survival (PFS) of 5.7 months (95% CI: 5.3-8.4 months) and 5.1 months (95% CI: 4.1-6.6 months) for HER2-overexpression and HER2-low ABC, respectively. Common (≥5%) grade 3 or higher treatment-emergent adverse events included neutrophil count decreased (17.6%), gamma-glutamyl transferase increased (13.2%), asthenia (11.0%), white blood cell count decreased (9.6%), peripheral neuropathy such as hypoesthesia (5.9%) and neurotoxicity (0.7%), and pain (5.9%).

conclusionDV demonstrated promising efficacy in HER2-overexpression and HER2-low ABC, with a favorable safety profile at 2.0 mg/kg Q2W.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesImmunoconjugatesAdultAgedAged, 80 and overFemaleHumansMiddle AgedERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesantibody‐drug conjugatebreast cancerclinical trialsdisitamab vedotinHER2‐lowHER2‐overexpression

Identifiers

PMID38940019
PMCPMC11260767

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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.