Evidence map›Paper›PMID 35445725›Full record

ArticleThe oncologist2022

Phase Ia/Ib Study of the Selective MET Inhibitor, Savolitinib, in Patients with Advanced Solid Tumors: 
Safety, Efficacy, and Biomarkers.

Yakun Wang, Tianshu Liu, Gongyan Chen, Jifang Gong, Yuxian Bai, Tao Zhang, Nong Xu, Li Liu, Jianming Xu, Jianxing He and 14 more

Open access · goldAbstract read
In one paragraph

Article in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.9field-weighted citation impact, top 14% 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

15 citing papers in PubMed, 14 citations in OpenAlex.

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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

24 authors at 13 institutions in 1 country.

Yakun WangKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Early Drug Development Center, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Tianshu LiuDepartment of Medical Oncology, Zhongshan Hospital, and Center of Evidence-Based Medicine, Fudan University, Shanghai, People's Republic of China.
Gongyan ChenDepartment of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, People's Republic of China.
Jifang GongKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology/Early Drug Development Center, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Yuxian BaiGastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, People's Republic of China.
Tao ZhangCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.
Nong XuDepartment of Medical Oncology, The First Affiliated Hospital of Zhejiang University, Hangzhou, People's Republic of China.
Li LiuCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.
Jianming XuDepartment of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, People's Republic of China.
Jianxing HeDepartment of Thoracic Surgery/Oncology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People's Republic of China.
Yunpeng LiuDepartment of Medical Oncology, The First Hospital of China Medical University, Shenyang, People's Republic of China.
Li ZhangState Key Laboratory of Oncology in South China, Guangzhou, People's Republic of China.
Da JiangDepartment of Medical Oncology, the Fourth Hospital of Hebei Medical University, Shijiazhuang, People's Republic of China.
Mengzhao WangDepartment of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
Jianhua ChangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Wei LiCancer Center, The First Hospital of Jilin University, Changchun, Jilin, People's Republic of China.
Chunmei BaiDepartment of Medical Oncology, Chinese Academy of Medical Science, Peking Union Medical College Hospital, Beijing, People's Republic of China.
Jinghong ZhouHutchison China MediTech Limited, Shanghai, People's Republic of China.
Jian WangHutchison China MediTech Limited, Shanghai, People's Republic of China.
Yongxin RenHutchison China MediTech Limited, Shanghai, People's Republic of China.
Liya ZhangHutchison China MediTech Limited, Shanghai, People's Republic of China.
Weiguo SuHutchison China MediTech Limited, Shanghai, People's Republic of China.
Baorui LiuThe Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, People's Republic of China.
Lin ShenKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology/Early Drug Development Center, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.ORCID 0000-0002-8798-4756
Chinese Academy of Medical Sciences & Peking Union Medical College · CNPeking University · CNHarbin Medical University · CNSun Yat-sen University · CNUnion Hospital · CNChinese PLA General Hospital · CNFirst Affiliated Hospital of Guangzhou Medical University · CNFirst Hospital of China Medical University · CNFudan University · CNHebei Medical University · CNJilin University · CNNanjing Drum Tower Hospital · CNZhejiang University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSavolitinib has shown good tolerability and preliminary efficacy, but efficacy biomarkers require investigation. The main purpose of this study was to confirm in Chinese patients the recommended phase II dose (RP2D) of savolitinib and to explore overall benefit in tumors bearing c-Met aberration.

methodsThis was an open-label, multi-center, 2-part phase I study. A starting dose of 600 mg QD was initiated in the escalation phase, utilizing a 3+3 design with repeated QD and BID dosing. In the dose expansion phase, we enrolled patients with gastric cancer and non-small cell lung cancer (NSCLC) with documented c-met aberration into 5 cohorts to further explore biomarkers. c-Met overexpression and amplification were assessed by immunohistochemistry and FISH, respectively.

resultsThe safety analysis set included 85 patients. Only one dose-limiting toxicity (grade 3 fatigue) was reported in the 600 mg BID dosing group. The most frequent treatment-related adverse events were nausea (29.4%), vomiting (27.1%), and peripheral edema (21.2%). Notably, in gastric cancer, response was only observed in patients with MET amplification (copy number 9.7-18.4), with an objective response rate of 35.7% and a disease control rate of 64.3%. For patients with NSCLC bearing a MET exon 14 skipping mutation, obvious target lesion shrinkage was observed in 2 of 4 patients, although PR was not achieved.

conclusionThe RP2D of savolitinib was established as 600 mg QD or 500 mg BID in Chinese patients. The promising response observed in patients with gastric cancer with c-met amplification and NSCLC with MET exon 14 skipping mutation warrants further investigation. CLINICALTRIALS.GOV IDENTIFIER: NCT0198555.

Indexed as

biomarkerC-met inhibitorsavolitinibtargeted therapy

Identifiers

PMID35445725
PMCPMC9074963
OpenAlexW4206631328

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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.