Delving into the Latest Updates on Trastuzumab biosimilar (Alteogen) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Herceptin biosimilar, Trastuzumab Biosimilar (Alteogen, Inc.), 曲妥珠单抗生物类似药（Alteogen, Inc.）

+ [8]

Target

HER2

Mechanism

HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesDigestive System Disorders

Active Indication

HER2 Positive Breast CancerHER2-positive gastric cancerMetastatic human epidermal growth factor 2 positive carcinoma of breast+ [3]

Inactive Indication-

Originator Organization

Alteogen, Inc.

Active Organization

Alteogen, Inc.

Qilu Pharmaceutical Co., Ltd.Cristalia SRL

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (28 Jun 2024),

HER2 Positive Breast CancerHER2-positive gastric cancer

Regulation-

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Gene Sequence

Sequence Code 18481L

The sequence is quoted from: *****

Sequence Code 44772H

The sequence is quoted from: *****

This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of QL1701 and Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.

Start Date29 Apr 2020

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

CTR20192189 / CompletedPhase 3

比较QL1701与赫赛汀分别联合多西他赛未经治HER2阳性转移性乳腺癌患者中有效性和安全性III期临床

[Translation] Phase III clinical trial comparing the efficacy and safety of QL1701 and Herceptin combined with docetaxel in patients with HER2-positive metastatic breast cancer who have not been treated with HER2

主要研究目的：评价注射用重组抗HER2人源化单克隆抗体（QL1701）和对照药赫赛汀分别联合多西他赛在未经治疗HER2阳性转移性乳腺癌患者中的有效性是否等效。次要研究目的：评价注射用重组抗HER2人源化单克隆抗体（QL1701）和赫赛汀分别联合多西他赛在未经治疗HER2阳性转移性乳腺癌中的安全性和免疫原性是否相似。

[Translation]

Main study objectives: To evaluate whether the efficacy of recombinant anti-HER2 humanized monoclonal antibody for injection (QL1701) and the control drug Herceptin combined with docetaxel in patients with untreated HER2-positive metastatic breast cancer is equivalent. Secondary study objectives: To evaluate whether the safety and immunogenicity of recombinant anti-HER2 humanized monoclonal antibody for injection (QL1701) and Herceptin combined with docetaxel in patients with untreated HER2-positive metastatic breast cancer are similar.

Start Date14 Apr 2020

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Trastuzumab biosimilar (Alteogen)

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100 Translational Medicine associated with Trastuzumab biosimilar (Alteogen)

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100 Patents (Medical) associated with Trastuzumab biosimilar (Alteogen)

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9

Literatures (Medical) associated with Trastuzumab biosimilar (Alteogen)

01 Sep 2024·ESMO Open

QL1701 (a proposed trastuzumab biosimilar) versus reference trastuzumab plus docetaxel as first-line therapy for HER2-positive metastatic breast cancer: a multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial

Article

Author: Kang, X-Y ; Zhang, Q.-Y. ; Cai, R-G ; Cai, R.-G. ; Li, C-J ; Li, H-P ; Zhang, B.-H. ; Xu, B.-H. ; Zhang, Q-Y ; Song, G-H ; Xu, B-H ; Song, G.-H. ; Li, H.-P. ; Kang, X.-Y. ; Zhang, B-H ; Li, C.-J.

BACKGROUNDQL1701 is a proposed biosimilar to the reference trastuzumab (Herceptin®). This trial compared the efficacy and safety of QL1701 with the reference trastuzumab in first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.MATERIALS AND METHODSThis randomized, double-blinded, parallel-controlled, phase III equivalence trial was conducted in 73 centers in China. Eligible patients with histologically or cytologically diagnosed HER2-positive metastatic breast cancer were randomly assigned (1 : 1) to receive either QL1701 or reference trastuzumab in combination with docetaxel (every 3 weeks) for eight cycles as the first-line treatment. Then, in patients with objective responses or stable disease, the QL1701 or reference trastuzumab with or without docetaxel was maintained for totally up to 12 months if tolerated. The primary endpoint was 24-week objective response rate (ORR) assessed by an independent review committee (IRC). The equivalence margin was 0.80-1.25 with a 90% confidence interval (CI) for the ORR ratio (QL1701 to reference trastuzumab).RESULTSBetween 29 April 2020 and 15 March 2022, 474 patients were randomized, and 473 received either QL1701 (n = 236) or reference trastuzumab (n = 237). The risk ratio for 24-week ORR was 1.07 (90% CI 0.94-1.21). The 90% CI fell within the pre-specified equivalence margin of 0.80-1.25. The 24-week ORR assessed by IRC was 59.7% (95% CI 53.2% to 66.1%) versus 56.1% (95% CI 49.5% to 62.5%) in QL1701 and the reference trastuzumab, respectively. As of 12 April 2023, there were no notable differences in progression-free survival (median: 8.3 versus 8.4 months) and overall survival (1-year rate: 95.1% versus 93.3%) between the two groups. Safety, pharmacokinetic (PK), and immunogenicity profiles were similar between the two groups.CONCLUSIONQL1701 demonstrated equivalent efficacy and similar safety to the reference trastuzumab when combined with docetaxel in the first-line treatment of patients with HER2-positive metastatic breast cancer, with similar PK and immunogenicity profiles.

01 May 2018·Royal Society Open ScienceQ3 · CROSS-FIELD

Elucidation of immunological response and its regulatory network by P-TUFT-ALT-2: a promising fusion protein vaccine for human lymphatic filariasis

Q3 · CROSS-FIELD

ArticleOA

Author: Kaliraj, Perumal ; Jaiswal, Sandeep ; Paul, Rajkumar ; Mahalakshmi, Natarajan

Human lymphatic filariasis, a mosquito-borne neglected tropical parasitic disease, needs an early development of prophylactic agents such as a vaccine for its successful elimination. Our earlier study suggested the enhanced immunological response by fusion protein (P-TUFT-ALT-2) of Tuftsin and ALT-2 in a mice model. We cultured human peripheral blood mononuclear cells (PBMCs) and treated cells withEscherichia coli-expressed ALT-2 (E-ALT-2) and P-TUFT-ALT-2. Real-time polymerase chain reaction was performed to identify the mRNA copy number of various cytokine and transcription factor genes. The recombinant vaccine candidate was also validated for humans by immunoreactivity with human sera samples of natural infection. In this study, P-TUFT-ALT-2 stimulated 12% higher PBMC proliferation in endemic normal (EN) individuals than E-ALT-2 alone. There was enhanced production of IFNγ, IL-2, IL-5 and IL-12, indicating a balanced Th1/Th2 response. However, higher expression of IL-5 and lower IL-4 validate the humoral response through an IL-5-dependent manner. Also, high level of IL-17 indicates a strong Th/Treg regulation over T-cell activation. The upregulated T-bet might have enhanced IFN-γ production, whereas GATA-3 was supposed to enhance IL-5 expression. The fusion protein also exhibited 15–16% higher reactivity with EN clinical sera, exposing the upregulation of IgG1 and IgM in natural infection. The higher reactivity of P-TUFT-ALT-2 with sera of natural infection (EN) was validated indirectly by B-cell activation through various cytokines and regulatory genes produced from different T cells. Thus, these findings endorse P-TUFT-ALT-2 as a potential vaccine candidate for human lymphatic filariasis.

01 Jan 2017·Journal of HelminthologyQ3 · BIOLOGY

Epitope mapping ofBrugia malayiALT-2 and the development of a multi-epitope vaccine for lymphatic filariasis

Q3 · BIOLOGY

Article

Author: Madhumathi, J ; Reddy, M V R ; Prince, P R ; Rao, D N ; Karande, A A ; Kaliraj, P

AbstractHuman lymphatic filariasis is a neglected tropical disease, causing permanent and long-term disability with severe immunopathology. Abundant larval transcript (ALT) plays a crucial role in parasite establishment in the host, due to its multi-faceted ability in host immune regulation. Although ALT protein is a key filarial target, its exact function is yet to be explored. Here, we report epitope mapping and a structural model ofBrugia malayiALT-2, leading to development of a multi-epitope vaccine. Structural analysis revealed that ALT represents unique parasitic defence proteins belonging to a toxin family that carries a ‘knottin’ fold. ALT-2 has been a favourite vaccine antigen and was protective in filarial models. Due to the immunological significance of ALT-2, we mapped B-cell epitopes systematically and identified two epitope clusters, 1–30 and 89–128. To explore the prophylactic potential of epitope clusters, a recombinant multi-epitopic gene comprising the epitopic domains was engineered and the protective efficacy of recombinant ALT epitope protein (AEP) was tested in the permissive model,Mastomys coucha. AEP elicited potent antibody responses with predominant IgG1 isotype and conferred significantly high protection (74.59%) compared to ALT-2 (61.95%). This proved that these epitopic domains are responsible for the protective efficacy of ALT-2 and engineering protective epitopes as a multi-epitope protein may be a novel vaccine strategy for complex parasitic infections.

100 Deals associated with Trastuzumab biosimilar (Alteogen)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC03	DB00072

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Breast Cancer	CN	Qilu Pharmaceutical Co., Ltd.	28 Jun 2024
HER2-positive gastric cancer	CN	Qilu Pharmaceutical Co., Ltd.	28 Jun 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	CN	Qilu Pharmaceutical Co., Ltd.	29 Apr 2020
Breast Cancer	Phase 1	-	Alteogen, Inc.	-
Breast Cancer	Phase 1	-	Cristalia SRL	-
Esophageal Carcinoma	Phase 1	CN	Qilu Pharmaceutical Co., Ltd.	-
Esophageal Carcinoma	Phase 1	-	Alteogen, Inc.	-
Esophageal Carcinoma	Phase 1	-	Cristalia SRL	-
Stomach Cancer	Phase 1	-	Alteogen, Inc.	-
Stomach Cancer	Phase 1	-	Cristalia SRL	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05629949 (NEWS) Manual	Phase 3	HER2 Positive Breast Cancer First line	473	QL1701	(scghxqoepm) = svtcrdwund qadbtnbflb (hwjgpvteut ) View more	Positive	12 Sep 2024
				原研曲妥珠单抗	(scghxqoepm) = slzjnrteqj qadbtnbflb (hwjgpvteut ) View more