Evidence map›Paper›PMID 38310192›Full record

Trial reportNature communications2024

The anti-PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel in first-line treatment of metastatic triple-negative breast cancer: a multicenter phase II trial.

Qiao Li, Jiaxuan Liu, Qingyuan Zhang, Quchang Ouyang, Yang Zhang, Qiang Liu, Tao Sun, Feng Ye, Baochun Zhang, Summer Xia and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03872791 (A Phase Ib/II Study to Evaluate Efficacy, Safety and Tolerability of KN046 Monotherapy or in Combination With Nab-paclitaxel in Subjects With Triple-negative Breast Cancer), which is not on this map. Cited by 54 papers.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed
18.9field-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.

NCT03872791 phase1 / phase2completednot on this map

A Phase Ib/II Study to Evaluate Efficacy, Safety and Tolerability of KN046 Monotherapy or in Combination With Nab-paclitaxel in Subjects With Triple-negative Breast Cancer

TypeinterventionalSponsorJiangsu Alphamab Biopharmaceuticals Co., LtdRan2019 to 2022Enrolled52ConditionsTriple-negative Breast CancerArmsKN046, Nab-paclitaxel
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 67 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

12 authors at 9 institutions in 2 countries.

Qiao LiDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.ORCID 0000-0002-4547-1266
Jiaxuan LiuDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Qingyuan ZhangHarbin Medical University Cancer Hospital/Oncology Department, Harbin, Heilongjiang, 150076, China.
Quchang OuyangHunan Cancer Hospital, Changsha, Hunan, 410031, China.
Yang ZhangLiaocheng People's Hospital, Liaocheng, Shandong, 252004, China.
Qiang LiuBreast Tumor Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, 510120, China.ORCID 0000-0002-5451-4862
Tao SunLiaoning Cancer Hospital & Institute, Cancer Hospital of China Medical University, Shenyang, Liaoning, 110801, China.
Feng YeThe First Affiliated Hospital of Xiamen University, Xiamen University, Xiamen, Fujian, 361003, China.ORCID 0000-0002-9159-7767
Baochun ZhangNantong Tumor Hospital, Nantong, Jiangsu, 226006, China.
Summer XiaJiangsu Alphamab Biopharmaceuticals Co., Ltd., Suzhou, Jiangsu, 215127, China.
Bangyong ZhangJiangsu Alphamab Biopharmaceuticals Co., Ltd., Suzhou, Jiangsu, 215127, China.
Binghe XuState Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. xubinghe@medmail.com.cn.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNNantong Tumor Hospital · CNFirst Affiliated Hospital of Xiamen University · CNHarbin Medical University · CNHunan Cancer Hospital · CNJiangsu T-mab BioPharma (China) · CNLiaocheng People's Hospital · CNLiaoning Cancer Hospital & Institute · CNSun Yat-sen University · CN

Funding

CAMS | Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Cancer Institute and Hospital) CICAMS-MOTRP2022004Chinese Academy of Medical Sciences (CAMS) CIFMS 2021-I2M-1-014Chinese Academy of Medical Sciences (CAMS) CIFMS 2022-I2M-2-002
6 · The paper itself

Abstract

This multicenter, phase II study (NCT03872791) aims to evaluate the efficacy and safety of the anti-PD-L1/CTLA-4 bispecific antibody KN046 combined with nab-paclitaxel in the first-line treatment of patients with metastatic triple-negative breast cancer (TNBC). The primary endpoints included objective response rate (ORR) and duration of response (DoR), and secondary endpoints included progression-free survival (PFS), overall survival (OS) rate, safety, and the correlation of PD-L1 status with clinical efficacy. This trial met pre-specified endpoints. 27 female patients were enrolled sequentially to receive KN046 in two dose levels (3 mg/kg or 5 mg/kg). Among the 25 evaluable patients, the ORR achieved 44.0% (95% CI, 24.4% - 65.1%), and the median DoR was not mature. The median PFS reached 7.33 months (95%CI, 3.68 - 11.07 months), and the median OS was 30.92 months (95%CI, 14.75 - NE months). In PD-L1 positive patients, PFS was 8.61 months (versus 4.73 months) and the 2-year OS rate was 62.5% (versus 57.1%) compared to PD-L1 negative patients. Patients tolerated well the combination therapy. In general, KN046 combined with nab-paclitaxel showed favorable efficacy and survival benefits with tolerable toxicity in the first-line treatment of metastatic TNBC, especially PD-L1 positive, which is worth further investigation.

Indexed as

Antineoplastic AgentsTriple Negative Breast NeoplasmsAlbuminsAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCTLA-4 AntigenFemaleHumansPaclitaxel130-nm albumin-bound paclitaxelAlbuminsAntineoplastic AgentsB7-H1 AntigenCTLA-4 AntigenPaclitaxel

Identifiers

PMID38310192
PMCPMC10838317
OpenAlexW4391512855

What OpenQuestion holds

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LicenceCC BY
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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.