Delving into the Latest Updates on Margetuximab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-HER2-monoclonal-antibody-Green-Cross, Margetuximab (USAN), Margetuximab-cmkb

+ [3]

Target

HER2

Action

antagonists

Mechanism

HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesOther Diseases+ [1]

Active Indication

HER2 Positive Breast CancerGastrooesophageal junction cancerHER2-positive gastric cancer+ [3]

Inactive Indication

Esophageal CarcinomaHER2 Positive CancerHER2 positive Gastrooesophageal junction cancer+ [2]

Originator Organization

MacroGenics, Inc.

Active Organization

Zai Lab (Shanghai) Co., Ltd.

MacroGenics, Inc.

Inactive Organization-

License Organization

Eversana Life Science Services LLC

Green Cross China Biological Products Co., Ltd.

TerSera Therapeutics LLC

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (16 Dec 2020),

HER2 Positive Breast Cancer

RegulationFast Track (United States), Orphan Drug (United States)

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Structure/Sequence

Sequence Code 197050L

Source: *****

Sequence Code 197056H

Source: *****

主要研究目的：评估Margetuximab联合化疗治疗中国HER2表达阳性的既往接受过抗HER2靶向治疗失败的转移性乳腺癌患者的药代动力学（PK）特征。次要研究目的：评估margetuximab联合化疗治疗HER2表达阳性的既往接受过抗HER2靶向治疗失败的转移性乳腺癌的安全性及耐受性评价针对margetuximab的抗药物抗体（ADA）及其对PK、疗效和安全性的影响

[Translation]

The primary study objective is to evaluate the pharmacokinetic (PK) characteristics of margetuximab combined with chemotherapy in the treatment of Chinese patients with HER2-positive metastatic breast cancer who have previously failed anti-HER2 targeted therapy. The secondary study objectives are to evaluate the safety and tolerability of margetuximab combined with chemotherapy in the treatment of HER2-positive metastatic breast cancer who have previously failed anti-HER2 targeted therapy. To evaluate anti-drug antibodies (ADA) against margetuximab and their effects on PK, efficacy and safety.

Start Date28 Aug 2020

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

NCT04398108

/ CompletedPhase 1

An Open-Label, Single-arm, Phase I Study to Evaluate the Pharmacokinetics, Tolerability and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies

This is an open-label, Single-arm, Phase I clinical study to evaluate the pharmacokinetics, tolerability and safety of margetuximab plus chemotherapy in Chinese patients with advanced HER2+ breast cancer who have received standard anti-HER2 directed therapy in the metastatic setting (mandatory including trastuzumab).
The primary endpoint of this study is PK parameters of margetuximab.

Start Date25 Aug 2020

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

100 Clinical Results associated with Margetuximab

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100 Translational Medicine associated with Margetuximab

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100 Patents (Medical) associated with Margetuximab

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54

Literatures (Medical) associated with Margetuximab

01 May 2024·Anti-Cancer Agents in Medicinal Chemistry

An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021)

Review

Author: Vishakha, S ; Kurmi, Balak Das ; Patel, Preeti ; Navneesh, N ; Jain, Ankit ; Gupta, Ghanshyam Das ; Verma, Sant Kumar

Abstract:New drugs being established in the market every year produce specified structures for selective biological targeting. With medicinal insights into molecular recognition, these begot molecules open new rooms for designing potential new drug molecules. In this review, we report the compilation and analysis of a total of 56 drugs including 33 organic small molecules (Mobocertinib, Infigratinib, Sotorasib, Trilaciclib, Umbralisib, Tepotinib, Relugolix, Pralsetinib, Decitabine, Ripretinib, Selpercatinib, Capmatinib, Pemigatinib, Tucatinib, Selumetinib, Tazemetostat, Avapritinib, Zanubrutinib, Entrectinib, Pexidartinib, Darolutamide, Selinexor, Alpelisib, Erdafitinib, Gilteritinib, Larotrectinib, Glasdegib, Lorlatinib, Talazoparib, Dacomitinib, Duvelisib, Ivosidenib, Apalutamide), 6 metal complexes (Edotreotide Gallium Ga-68, fluoroestradiol F-18, Cu 64 dotatate, Gallium 68 PSMA-11, Piflufolastat F-18, 177Lu (lutetium)), 16 macromolecules as monoclonal antibody conjugates (Brentuximabvedotin, Amivantamab-vmjw, Loncastuximabtesirine, Dostarlimab, Margetuximab, Naxitamab, Belantamabmafodotin, Tafasitamab, Inebilizumab, SacituzumabGovitecan, Isatuximab, Trastuzumab, Enfortumabvedotin, Polatuzumab, Cemiplimab, Mogamulizumab) and 1 peptide enzyme (Erwiniachrysanthemi-derived asparaginase) approved by the U.S. FDA between 2018 to 2021. These drugs act as anticancer agents against various cancer types, especially non-small cell lung, lymphoma, breast, prostate, multiple myeloma, neuroendocrine tumor, cervical, bladder, cholangiocarcinoma, myeloid leukemia, gastrointestinal, neuroblastoma, thyroid, epithelioid and cutaneous squamous cell carcinoma. The review comprises the key structural features, approval times, target selectivity, mechanisms of action, therapeutic indication, formulations, and possible synthetic approaches of these approved drugs. These crucial details will benefit the scientific community for futuristic new developments in this arena.

12 Jan 2024·Cancer Discovery

Tebotelimab Is Safe and Effective Across Multiple Cancer Types

Article

AbstractThe PD-1 × LAG-3 bispecific molecule tebotelimab is safe as a monotherapy and in combination with margetuximab.

01 Jan 2024·Clinics and Research in Hepatology and Gastroenterology

New developments and standard of care in the management of advanced gastric cancer

Review

Author: Broudin, Chloé ; Rasola, Cosimo ; Palle, Juliette ; Zaanan, Aziz ; Afrăsânie, Vlad-Adrian ; Depotte, Léonard ; Mariani, Antoine

Advanced gastric adenocarcinoma is a common disease with a poor prognosis whose treatment has for decades been based on cytotoxic chemotherapy, including platinum salts in first-line, and taxane or irinotecan in second or later line. Recent years have seen the emergence of new drugs that have improved patient survival, such as trastuzumab in first-line for HER2-positive tumors, ramucirumab alone or in combination with paclitaxel in second-line, and trifluridine-tipiracil beyond the second-line treatment. More recently, two monoclonal antibodies have demonstrated their efficacy in combination with oxaliplatin-based first-line chemotherapy, nivolumab (anti-PD1) for PD-L1 CPS ≥5 tumors, and zolbetuximab for tumors overexpressing Claudin 18.2. In addition, regorafenib has been also showed effective in phase 3 trial for heavily pretreated patients. Based on phase 2 studies, trastuzumab-deruxtecan was approved in 2022 by the EMA for HER2-positive pretreated patients. This agent is currently evaluated in phase 3 study (DESTINY-Gastric04 trial), as are several other anti-HER2 (zanidatamab, margetuximab, tucatinib), immune checkpoint inhibitors, or targeted therapies (anti-FGFR2b).

26

News (Medical) associated with Margetuximab

30 Oct 2024

·www.globenewswire.com

MacroGenics Announces Leadership Transition

Scott Koenig, M.D., Ph.D., to step down as President and CEOBoard to initiate search process to identify new CEO ROCKVILLE, MD, Oct. 30, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that Scott Koenig, M.D., Ph.D., intends to step down as President and Chief Executive Officer early next year. The Company’s Board of Directors has retained Heidrick & Struggles to lead a search process to identify its next Chief Executive Officer and has established a special committee of the Board to oversee the transition process. William Heiden, Chairman of the Board of Directors said, “Scott was a co-founder of MacroGenics twenty-four years ago and the Company has achieved many milestones under his leadership – including several partnered or company-owned FDA approved monoclonal antibody therapeutics developed by the company. On behalf of the Board, I want to thank Scott for his incredible dedication to the Company’s mission of discovering and developing novel therapeutics to improve patient care.” Mr. Heiden continued, “Today, MacroGenics has several innovative antibody-based therapeutics in development for the treatment of cancer, as well as significant alliances with leading pharmaceutical and biotechnology companies to develop and commercialize novel therapeutics. The Company today has a broad portfolio of promising assets and a strong balance sheet, and the Board and Scott agreed that this is the right time to transition to our next phase of leadership. We look forward to continuing to benefit from his perspectives as an advisor and shareholder.” “I am proud of our many achievements since our founding in 2000, in which we built a fully integrated, science-focused biotechnology company and have been successful in discovering, developing, manufacturing, and commercializing novel immunotherapeutics derived from our proprietary Fc-engineered antibody, bi-specific DART molecule, and antibody drug conjugate (ADC) technologies,” said Dr. Koenig. “Since the company’s IPO in 2013, we were able to fund a significant part of the development portfolio through the achievement of over $1 billion of non-dilutive capital via partnerships. Thanks to the incredible passion and dedication of the people at MacroGenics, three novel therapeutics from our pipeline advanced to approval, including MARGENZA® and ZYNYZ® to treat patients with cancer, and TZIELD® for individuals with early-stage Type 1 diabetes, and we have advanced a rich portfolio of clinical and preclinical molecules in development. I am confident that MacroGenics is well positioned in its current mission to address the significant unmet medical needs of patients with cancer. I look forward to continuing to support the Company in its work to achieve its key strategic objectives and create value for all our stakeholders.” About MacroGenics, Inc. MacroGenics is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and MARGENZA are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, expected timing of the release of final safety and efficacy data, including mature median rPFS and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, especially timing and results of mature median radiographic progression-free survival, other efficacy and safety data with respect to vobramitamab duocarmazine; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; availability and timing of data from ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. ###

Executive ChangeIPOADC

23 Oct 2024

·www.biopharmadive.com

Merck acquires cancer drug startup; Elevidys ex-US sales rise

Today, a brief rundown of news from Merck & Co. and Roche, as well as updates from Sangamo Therapeutics, UCB and Catalent that you may have missed.Merck & Co. will pay $30 million upfront to acquire Modifi Biosciences, a Yale University spinout developing small molecule drugs for cancer. Founded in 2021, Modifi focuses on DNA repair defects in cancer cells, specifically one repair protein known as MGMT for short. Shareholders in Modifi could receive up to $1.3 billion in additional payments if certain, unspecified milestones are met. Ned PagliaruloSales of Sarepta Therapeutics Duchenne muscular dystrophy gene therapy Elevidysoutside of the U.S. reached 137 million Swiss francs, or about $156 million, over the first nine months of the year, the companys international partner Roche said Wednesday. Those sales came from five ex-U.S. countries where Elevidys is also approved. A decision is expected in the EU next year, and Roche has submitted applications in several other countries. The Swiss group cited Elevidys, along with multiple sclerosis shot Ocrevus, as one of its key growth drivers in neurology, which showed a sales increase of 14% to 7 billion francs over the same period in 2023. Jonathan GardnerShares in Sangamo Therapeutics rose Tuesday after the company said it has secured agreement from the Food and Drug Administration on a path to filing its experimental Fabry disease treatment for approval. According to the biotechnology company, regulators agreed that a measure of kidney function could be used as a surrogate endpoint to ask it for accelerated clearance of the gene therapy, dubbed isaralgagene civaparvovec or ST-920. Sangamo expects to have the necessary data by the first half of next year, setting up a submission in the latter half of 2025 some three years earlier than the company had been planning. Ned PagliaruloRoche has returned to UCB rights to an experimental Alzheimers medicine UCB had licensed to the Swiss pharmaceutical company in 2020. The company confirmed Roches termination of the collaboration in a statement Tuesday announcing the planned presentation of Phase 2 study results for the drug, bepranemab, at an upcoming medical meeting. Tested in people with prodromal or mild Alzheimers, bepranemab is designed to target a protein known as tau in the brain. Ned PagliaruloMacroGenics, a developer of antibody medicines for cancer, on Tuesday said it sold rights to its breast cancer drug Margenza to privately held TerSera Therapeutics for $40 million. MacroGenics could receive up to $35 million more if certain sales milestones are met under the deal, which is expected to close in the fourth quarter. Margenza was approved in 2020 together with chemotherapy for adults with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens. Delilah AlvaradoCell therapy developer AvenCell Therapeutics raised $112 million in a Series B financing led by investor Novo Holdings. The funding will fund development of the companys switchable CAR-T medicines, which it claims could be safer and more effective than current options. F-Prime Capital, founding investor Blackstone Life Sciences and three other venture firms participated in the round. Delilah AlvaradoCatalent, the contract development and manufacturing organization being acquired by Novo Holdings, issued a letter Monday to its customers aimed at reassuring them it will continue to fulfill its commitments after the transaction closes. Novo Holdings, which is the parent company of drugmaker Novo Nordisk, is taking Catalent private through a $16.5 billion acquisition. Novo Nordisk is then buying three large Catalent plants in a separate $11 billion agreement. Alessandro Maselli, Catalents current CEO, will stay on in his role, the letter said. Ned Pagliarulo '

AcquisitionDrug ApprovalGene TherapyPhase 2

22 Oct 2024

·pipelinereview.com

MacroGenics Enters Into Agreement With TerSera Therapeutics for the Sale of MARGENZA®

ROCKVILLE, MD & DEERFIELD, IL, USA I October 22, 2024 I MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, and TerSera Therapeutics LLC, a privately-held biopharmaceutical company with a focus in oncology and non-opioid pain management, announced today that they have entered into an agreement in which TerSera will acquire global rights to MARGENZA® (margetuximab-cmkb). MARGENZA was approved by the U.S. Food and Drug Administration (FDA) in December 2020 in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. The approval was based on results from the pivotal Phase 3 head-to-head clinical trial (SOPHIA) evaluating the safety and efficacy of MARGENZA vs. Herceptin® (trastuzumab), both combined with chemotherapy. Pursuant to the terms of the agreement, TerSera will pay MacroGenics $40 million at closing. MacroGenics may receive additional sales milestone payments of up to an aggregate of $35 million. The transaction is expected to close in the fourth quarter of 2024, subject to customary closing conditions. “This transaction will enable us to focus our efforts on advancing our pipeline of novel and differentiated oncology product candidates,” said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. “We believe TerSera’s established and complementary U.S. commercial infrastructure has the potential to broaden patient access to MARGENZA.” “MARGENZA is an important treatment option for patients with metastatic HER2+ breast cancer,” said Edward Donovan, Chief Executive Officer of TerSera. “We are very excited to add MARGENZA to our existing oncology portfolio, deepening our commitment to the treatment of patients with breast cancer.” IMPORTANT SAFETY INFORMATION BOXED WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY WARNINGS & PRECAUTIONS: Left Ventricular Dysfunction Embryo-Fetal Toxicity Infusion-Related Reactions (IRRs) MOST COMMON ADVERSE REACTIONS: The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia (57%), nausea (33%), diarrhea (25%), vomiting (21%), constipation (19%), headache (19%), pyrexia (19%), alopecia (18%), abdominal pain (17%), peripheral neuropathy (16%), arthralgia/myalgia (14%), cough (14%), decreased appetite (14%), dyspnea (13%), infusion-related reactions (13%), palmar-plantar erythrodysesthesia (13%), and extremity pain (11%). You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469). INDICATION MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Please see full Prescribing Information , including Boxed Warning. About HER2-positive Breast Cancer Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Monoclonal antibodies targeting HER2 have greatly improved outcomes; however, a significant number of patients progress to later lines of therapy. Effective treatments for metastatic HER2-positive breast cancer continue to remain an unmet need. About MARGENZA MARGENZA (margetuximab-cmkb) is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Similar to trastuzumab, margetuximab-cmkb inhibits tumor cell proliferation, reduces shedding of the HER2 extracellular domain and mediates antibody-dependent cellular cytotoxicity (ADCC). However, through MacroGenics’ Fc Optimization technology, margetuximab-cmkb has been engineered to enhance the engagement of the immune system. In vitro, the modified Fc region of margetuximab-cmkb increases binding to the activating Fc receptor FCGR3A (CD16A) and decreases binding to inhibitor Fc receptor FCGR2B (CD32B). These changes lead to greater in vitro ADCC and NK cell activation. The clinical significance of in vitro data is unknown. About MacroGenics, Inc. MacroGenics is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com . About TerSera Therapeutics TerSera Therapeutics is a biopharmaceutical company with a focus in oncology and non-opioid pain management. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. TerSera has been recognized as a 2024 Healthcare Top Workplace. For additional information, please visit tersera .com and follow us on LinkedIn . SOURCE: MacroGenics

License out/inDrug ApprovalPhase 3Clinical ResultADC

100 Deals associated with Margetuximab

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External Link

KEGG	Wiki	ATC	Drug Bank
D10446	Margetuximab	L01XC	DB14967

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Breast Cancer	United States	MacroGenics, Inc.	16 Dec 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Breast Cancer	NDA/BLA	China	Zai Lab (Shanghai) Co., Ltd.	06 Jan 2022
Neoplasm Metastasis	Phase 1	United States	MacroGenics, Inc.	24 Aug 2015
Neoplasm Metastasis	Phase 1	Italy	MacroGenics, Inc.	24 Aug 2015
Neoplasm Metastasis	Phase 1	Canada	MacroGenics, Inc.	24 Aug 2015
Neoplasm Metastasis	Phase 1	France	MacroGenics, Inc.	24 Aug 2015
Neoplasm Metastasis	Phase 1	Portugal	MacroGenics, Inc.	24 Aug 2015
Neoplasm Metastasis	Phase 1	Spain	MacroGenics, Inc.	24 Aug 2015
Neoplasm Metastasis	Phase 1	Denmark	MacroGenics, Inc.	24 Aug 2015
Neoplasm Metastasis	Phase 1	Netherlands	MacroGenics, Inc.	24 Aug 2015
Neoplasm Metastasis	Phase 1	Finland	MacroGenics, Inc.	24 Aug 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04082364 (MAHOGANY \| NCT04082364 \| ###DELETE, CTgov)	Phase 2/3	Metastatic HER2 positive gastroesophageal junction cancer \| Gastrooesophageal junction cancer \| HER2-positive gastric cancer	82	margetuximab+Retifanlimab (Chemotherapy-free Arm)	jfiiqsznji(vovcgfsrwy) = tivzxdfnbq jsdcacnskl (rymbzkteue, oygmlpmlil - jyovaxywmm) View more	-	22 Apr 2025
				Chemotherapy+Trastuzumab (Trastuzumab and Chemotherapy Arm)	(hkovqytgng) = zzemdkidtf xsgtgxhfau (zblwvblouv, wcskuwjjgt - jjdjfaekwj) View more
NCT02689284 (CP-MGAH22-05, Pubmed)	Phase 1/2	HER2 Positive Gastroesophageal Adenocarcinoma	86	Margetuximab and Pembrolizumab combination therapy	(bqzcfjoera) = pitpwhfthl akcmzpgehq (fqdqjkegku )	-	25 Apr 2023
NCT02492711 (SOPHIA, CTgov)	Phase 3	Neoplasm Metastasis \| Metastatic human epidermal growth factor 2 positive carcinoma of breast	624	Physician's choice of chemotherapy.+Margetuximab (Margetuximab Plus Chemotherapy)	mmfdtwmbdf(wcxreiepny) = sgxcouzrwy okzjerognn (elmwcisgpw, jvrsxcgamm - uldahnhcwc) View more	-	23 Nov 2022
				Physician's choice of chemotherapy.+Trastuzumab (Trastuzumab Plus Chemotherapy)	mmfdtwmbdf(wcxreiepny) = zqsoudepxa okzjerognn (elmwcisgpw, waipxcicnx - iotuiplnbj) View more
NCT02492711 (SOPHIA, NEWS) Manual	Phase 3	HER2 Positive Breast Cancer HER2 positive	-	Chemotherapy+Margetuximab	(giwptepagz) = jcervgabyc rtbgeukyvx (qspamdewag ) View more	Superior	09 Nov 2022
				Chemotherapy+Trastuzumab	(giwptepagz) = uknsgfdyps rtbgeukyvx (qspamdewag ) View more
NCT02492711 (SOPHIA, Pubmed) Manual	Phase 3	Advanced HER2-Positive Breast Carcinoma HER2 Positive	536	Chemotherapy+Margetuximab	(ynssnxualj) = aodoicngmu xflrlglemv (rcihdnlgsi, 18.89 - 25.07)	Non-superior	04 Nov 2022
				Chemotherapy+Trastuzumab	(ynssnxualj) = cozidvjypb xflrlglemv (rcihdnlgsi, 18.69 - 24.18)
NCT04082364 (MAHOGANY, Pubmed) Manual	Phase 2/3	HER2 Positive Gastroesophageal Adenocarcinoma First line HER2 Positive \| PD-L1 Positive	43	Margetuximab+Retifanlimab	rgvzqbpter(bfoqtjelnx) = trpwnkvzwi qoycchwcdb (ooecglsmpa ) View more	Positive	24 Aug 2022
NCT02689284 (CP-MGAH22-05, CTgov)	Phase 1/2	Esophageal Carcinoma \| HER2 positive Gastrooesophageal junction cancer \| Metastatic HER2 positive gastroesophageal junction cancer \| HER2-positive gastric cancer \| Stomach Cancer	95	Margetuximab+Pembrolizumab (Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg))	gtfcualnqp(dvpgswzpem) = dselheffnu nfxdpjlqrj (bcuncwlnir, ddxecsfysp - ytqnfrrqaq) View more	-	04 Aug 2022
				Margetuximab+Pembrolizumab (Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg))	gtfcualnqp(dvpgswzpem) = nsypdymquf nfxdpjlqrj (bcuncwlnir, lwraadncbq - sqsgzswmrw) View more
ASCO2022	Phase 3	Advanced breast cancer	-	Margetuximab	(byumomytym) = these therapies are generally well tolerated with manageable side effects as listed in the table. gyqrcjrpep (kpocqhzsfi ) View more	Positive	02 Jun 2022
				Trastuzumab
NCT04082364 (ESMO_GI2021)	Phase 2/3	Metastatic HER2 positive gastroesophageal junction cancer First line HER2+ \| PD-L1+ \| microsatellite instability	-	Margetuximab+Retifanlimab	(azchafnjfo) = zstxirokzc cdbjwqkdbg (tqbtlzjclm )	Positive	03 Jul 2021
NCT02492711 (SOPHIA, SABCS2021)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast CD16A genotype	536	Margetuximab + Chemotherapy	orgpswduop(kjjhrsmxlo) = A higher proportion of patients experienced IRRs on the M arm (35 [13.3%]) than on the T arm (9 [3.4%]). Most IRRs in both groups were severity Grade 1 or 2, occurred on Cycle 1 Day 1, and resolved within 24 hours. In patients receiving M, Grade 3 IRR occurred in 4 patients (1.5%), including 3 after vinorelbine and 1 after eribulin. Adverse events associated with Grade 3 IRRs included chills, fever, nausea, diarrhea, dyspnea, and/or hypertension. Two patients receiving M (0.8%) discontinued due to IRR, versus none on T. Of patients with IRRs, the most common symptoms in both treatment groups were chills (M: 17 [48.6%]; T: 5 [55.6%]) and fever (M: 13 [37.1%]; T: 2 [22.2%]). There was no observed hypotension in either group. In both groups, more than half of IRR events were addressed by dose interruption only. All IRRs all were medically manageable. IRR rates were higher in patients without premedication for both groups. Of 264 subjects receiving M, 218 (82.6%) received premedication and 46 (17.4%) did not; IRRs were observed in 28 (12.8%) of those receiving premedication and 7 (15.2%) of those not premedicated. All 4 patients on M with Grade 3 IRRs received premedication, 3 with steroids. Of 266 subjects receiving T, 173 (65%) received premedication and 93 (35%) did not; IRRs were observed in 5 (2.9%) of those receiving premedication and 4 (4.3%) of those not premedicated. IRR risk was unaffected by chemotherapy subgroup or CD16A genotype. qujcbuoorv (tfrspheadi )	Positive	15 Feb 2021
				Trastuzumab + Chemotherapy

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.

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Understand key drug designations in just a few clicks with Synapse.