Drugs / Margetuximab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | Her2-receptor negative breast cancer | 2022-01-06 | “today announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for margetuximab” zailaboratory.com ↗ “The NMPA accepted the NDA filed by Zai Lab for margetuximab in HER2-positive breast cancer in China.” zailaboratory.com ↗ |
| Filed | US (FDA) | — | Her2-receptor negative breast cancer | 2019-12-19 | “today announced that the Company has submitted a Biologics License Application (BLA) for margetuximab” macrogenics.com ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04398108 | Aug 2020 → Apr 2021 | HER2 positive breast carcinoma | Zai Lab (Shanghai) Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03219268 | Aug 2017 → Feb 2023 | cervical cancer, cholangiocarcinoma, head and neck squamous cell carcinoma, hematopoietic and lymphoid cell neoplasm +4 | MacroGenics | Completed | No outcome recorded |
| Phase 1 | NCT01148849 | Jul 2010 → Jun 2022 | breast cancer, gastric cancer | MacroGenics | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02689284 | Jan 2016 → Jan 2021 | esophageal cancer, gastric cancer | MacroGenics | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05227131 | May 2022 → Oct 2024 | HER2 positive breast carcinoma | MedSIR | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04425018 | Jul 2020 → Oct 2024 overdue | HER2 positive breast carcinoma | Dana-Farber Cancer Institute | Active not recruiting | Missed primary |
| Phase 2 | NCT04262804 | Jan 2020 → Sep 2021 | breast carcinoma | Zai Lab (Shanghai) Co., Ltd. | Unknown | Met primary |
| Phase 2 | NCT01828021 | Mar 2013 → Dec 2016 | breast cancer | MacroGenics | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04082364 | Sep 2019 → Jan 2024 | gastric cancer, gastroesophageal junction adenocarcinoma | MacroGenics | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT02492711 | Aug 2015 → Aug 2021 | HER2 positive breast carcinoma, metastatic neoplasm | MacroGenics | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| — | NCT03133988 Background | — | HER2 positive breast carcinoma | TerSera Therapeutics LLC | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2022-01-06 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces NDA Acceptance of Margetuximab for Patients with Pretreated Metastatic HER2-Positive Breast Cancer in China by the NMPA zailaboratory.com ↗
Zai Lab Announces NDA Acceptance of Margetuximab for Patients with Pretreated Metastatic HER2-Positive Breast Cancer in China by the NMPA |
| 2021-10-05 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Announces Margetuximab Achieved Primary Objective in Bridging Study in Advanced HER2+ Breast Cancer in Greater China zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced that the bridging study of margetuximab plus chemotherapy in advanced, previously treated HER2+ breast cancer met its primary endpoint, with acceptable safety and tolerability. |
| 2021-09-16 | MacroGenics | Results MacroGenics Announces Clinical Results from Cohort A Part 1 of Phase 2/3 MAHOGANY Study of Margetuximab in Combination with Retifanlimab in Gastroesophageal Adenocarcinoma at ESMO 2021 macrogenics.com ↗
21 of 40 patients (53%) achieved confirmed responses by independent review, exceeding prespecified futility boundary for trial; enrollment proceeding to Part 2 of Cohort A |
| 2021-09-07 | MacroGenics | Results MacroGenics Announces Final Overall Survival Results from SOPHIA Study of MARGENZA™ in Patients with HER2-Positive Metastatic Breast Cancer macrogenics.com ↗
Final overall survival (OS) analysis did not demonstrate a statistically significant advantage for MARGENZA over trastuzumab |
| 2021-04-10 | MacroGenics | Results MacroGenics Announces Presentations at the 2021 AACR Annual Meeting macrogenics.com ↗ |
| 2021-01-25 | MacroGenics | Results MacroGenics Announces Publication of SOPHIA Trial Results for MARGENZA™ in JAMA Oncology macrogenics.com ↗
In the study, MARGENZA demonstrated a statistically significant 24% reduction in the risk of disease progression or death compared to Herceptin, each in combination with chemotherapy (Hazard Ratio [HR] = 0.76; 95% CI, 0.59-0.98; p=0.03; median PFS 5.8 vs. 4.9 months). |
| 2020-12-16 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Partner MacroGenics Announces FDA Approval of MARGENZA™ for Patients with Pretreated Metastatic HER2-Positive Breast Cancer zailaboratory.com ↗ |
| 2020-12-16 | MacroGenics | Regulatory MacroGenics Announces FDA Approval of MARGENZA™ for Patients with Pretreated Metastatic HER2-Positive Breast Cancer macrogenics.com ↗
MARGENZA is approved, 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 |
| 2020-07-09 | MacroGenics | Results MacroGenics Announces Lancet Oncology Publication of Margetuximab Data in Gastric Cancer macrogenics.com ↗
today announced that Lancet Oncology has published results from a Phase 2 study of margetuximab plus pembrolizumab as a chemotherapy-free regimen for patients with advanced HER2-positive gastroesophageal adenocarcinoma (GEA) who have previously been treated with chemotherapy and trastuzumab. |
| 2020-06-05 | MacroGenics | Regulatory MacroGenics Announces Margetuximab Granted Orphan Drug Designation in the U.S. for Gastric Cancer macrogenics.com ↗
MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to margetuximab, an investigational, Fc-engineered monoclonal antibody targeting HER2 for the treatment of gastric and gastroesophageal junction cancer. |
| 2020-05-28 | MacroGenics | Regulatory MacroGenics Provides Update on FDA Review of Margetuximab for HER2-Positive Metastatic Breast Cancer macrogenics.com ↗
The FDA also stated it continues to anticipate meeting the Prescription Drug User Fee Act (PDUFA) goal date for the application review, which is December 18, 2020 . |
| 2020-05-13 | MacroGenics | Results MacroGenics Announces Preliminary Clinical Results from MGD013 and MGC018 to be Presented at the ASCO Annual Meeting macrogenics.com ↗
preliminary observations in a Phase 1 trial suggest a response in approximately 40% of late-stage HER-2-positive tumors |
| 2019-12-19 | MacroGenics | Regulatory MacroGenics Announces Submission of Margetuximab Biologics License Application to U.S. FDA macrogenics.com ↗
today announced that the Company has submitted a Biologics License Application (BLA) for margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2. |
| 2019-12-11 | MacroGenics | Results MacroGenics Presents Results from the SOPHIA Study of Margetuximab in Patients with HER2-Positive Metastatic Breast Cancer at the San Antonio Breast Cancer Symposium macrogenics.com ↗
today presented updated results from the Phase 3 SOPHIA study comparing margetuximab plus chemotherapy versus trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer who have previously been treated with anti-HER2-targeted therapies. |
| 2019-10-22 | MacroGenics | Results MacroGenics Announces Second Interim Overall Survival Data from Phase 3 SOPHIA Study of Margetuximab in Patients with HER2-Positive Metastatic Breast Cancer macrogenics.com ↗
In the intent-to-treat (ITT) population, the median OS of patients treated with margetuximab and chemotherapy was prolonged by 1.8 months compared to that of patients who received trastuzumab and chemotherapy (21.6 months versus 19.8 months; hazard ratio [HR]=0.885; 95% CI: 0.693-1.130; p=0.326). |
| 2019-09-30 | MacroGenics | Results MacroGenics Presents Margetuximab Data in Gastroesophageal Cancer at the ESMO 2019 Congress macrogenics.com ↗
Data were presented at the European Society for Medical Oncology ( ESMO ) Annual Congress 2019. |
| 2019-05-15 | MacroGenics | Results MacroGenics Announces Positive Results from Phase 3 SOPHIA Study of Margetuximab in Patients with HER2-Positive Metastatic Breast Cancer macrogenics.com ↗
The median PFS of patients treated with margetuximab and chemotherapy was 5.8 months compared to 4.9 months in patients treated with trastuzumab and chemotherapy (hazard ratio [HR]=0.76; 95% CI: 0.59-0.98; P=0.033). |
| 2019-04-03 | MacroGenics | Results MacroGenics Reports Presentation of Data at the AACR Annual Meeting 2019 macrogenics.com ↗
Preclinical data presented at AACR showed that margetuximab, while retaining the same Fc-independent tumor growth-inhibition activity as trastuzumab, exhibited more potent antibody-dependent cell-mediated cytotoxicity (ADCC) and induced greater activation and proliferation of NK cells in vitro compared to trastuzumab. |
| 2019-02-06 | MacroGenics | Results MacroGenics Announces Positive Results from Pivotal Phase 3 SOPHIA Study of Margetuximab macrogenics.com ↗
The SOPHIA clinical trial met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. |
| 2019-01-17 | MacroGenics | Results Updated Clinical Data from Combination of Margetuximab and Pembrolizumab in Gastric Cancer Presented at 2019 ASCO Gastrointestinal Cancers Symposium macrogenics.com ↗
Updated Clinical Data from Combination of Margetuximab and Pembrolizumab in Gastric Cancer Presented at 2019 ASCO Gastrointestinal Cancers Symposium |
| 2018-01-23 | MacroGenics | Results MacroGenics Announces Continuation of SOPHIA Study of Margetuximab Based on Completion of Interim Futility Analysis macrogenics.com ↗
MacroGenics Announces Continuation of SOPHIA Study of Margetuximab Based on Completion of Interim Futility Analysis |
| 2015-05-30 | MacroGenics | Results MacroGenics Presents Updated Data from Phase 1 Study of Margetuximab at ASCO Annual Meeting 2015 macrogenics.com ↗
MacroGenics Presents Updated Data from Phase 1 Study of Margetuximab at ASCO Annual Meeting 2015 |
| 2013-06-03 | MacroGenics | Results MacroGenics Presents Phase 1 Data at ASCO Showing Signs of Clinical Benefit for Margetuximab in HER2 Expressing Tumors; Phase 2 Clinical Trial Underway to Evaluate Activity in Patients with Advanced Breast Cancer macrogenics.com ↗
MacroGenics Presents Phase 1 Data at ASCO Showing Signs of Clinical Benefit for Margetuximab in HER2 Expressing Tumors; Phase 2 Clinical Trial Underway to Evaluate Activity in Patients with Advanced Breast Cancer |
All press releases naming this drug 37 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | margetuximab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03219268 ↗ |
| Known as | Margenza | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364649 ↗ |
| Known as | Margetuximab cmkb | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364649 ↗ |
| Known as | MGAH22 | “First-in-human phase 1 study of margetuximab (MGAH22), an Fc-modified chimeric monoclonal antibody, in patients with HER2-positive advanced solid tumors.” PMID 28119295 ↗ Apr 2017 |
| Action | Inhibit | “anti-HER2 monoclonal antibody” PMID 32653053 ↗ Jul 2020 |
| Modality | Monoclonal antibody | “First-in-human phase 1 study of margetuximab (MGAH22), an Fc-modified chimeric monoclonal antibody, in patients with HER2-positive advanced solid tumors.” PMID 28119295 ↗ Apr 2017 |
| Route | Intravenous | “treated with margetuximab by intravenous infusion” PMID 28119295 ↗ Apr 2017 |
| Target | ERBB2 | “Margetuximab is an anti-HER2 antibody” PMID 28119295 ↗ Apr 2017 |