MAHOGANY: margetuximab combination in HER2+ unresectable/metastatic gastric/gastroesophageal junction adenocarcinoma
Standard-of-care, first-line therapy for patients with advanced HER2+ gastric/gastroesophageal junction adenocarcinoma is chemotherapy plus trastuzumab, a monoclonal antibody (mAb) targeting HER2. Margetuximab is an Fc-optimized mAb that binds HER2. Retifanlimab, a humanized IgG4 mAb, binds to PD-1...
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| Published in | Future oncology (London, England) Vol. 17; no. 10; pp. 1155 - 1164 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Future Medicine Ltd
01.04.2021
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1479-6694 1744-8301 1744-8301 |
| DOI | 10.2217/fon-2020-1007 |
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| Abstract | Standard-of-care, first-line therapy for patients with advanced HER2+ gastric/gastroesophageal junction adenocarcinoma is chemotherapy plus trastuzumab, a monoclonal antibody (mAb) targeting HER2. Margetuximab is an Fc-optimized mAb that binds HER2. Retifanlimab, a humanized IgG4 mAb, binds to PD-1 and blocks its interaction with PD-L1/2. Tebotelimab, an IgG4κ bispecific DART
molecule, binds PD-1 and lymphocyte activation gene 3 concomitantly, disrupting these nonredundant inhibitory pathways to further restore exhausted T-cell function. Here, we describe the design and rationale of the randomized, open-label, Phase II/III MAHOGANY trial evaluating margetuximab plus retifanlimab with/without chemotherapy and margetuximab plus tebotelimab with chemotherapy in first-line unresectable metastatic/locally advanced gastroesophageal junction adenocarcinoma. Primary end points include objective response rate, overall survival and safety/tolerability. |
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| AbstractList | Standard-of-care, first-line therapy for patients with advanced HER2+ gastric/gastroesophageal junction adenocarcinoma is chemotherapy plus trastuzumab, a monoclonal antibody (mAb) targeting HER2. Margetuximab is an Fc-optimized mAb that binds HER2. Retifanlimab, a humanized IgG4 mAb, binds to PD-1 and blocks its interaction with PD-L1/2. Tebotelimab, an IgG4κ bispecific DART
molecule, binds PD-1 and lymphocyte activation gene 3 concomitantly, disrupting these nonredundant inhibitory pathways to further restore exhausted T-cell function. Here, we describe the design and rationale of the randomized, open-label, Phase II/III MAHOGANY trial evaluating margetuximab plus retifanlimab with/without chemotherapy and margetuximab plus tebotelimab with chemotherapy in first-line unresectable metastatic/locally advanced gastroesophageal junction adenocarcinoma. Primary end points include objective response rate, overall survival and safety/tolerability.
NCT04082364 (ClinicalTrials.gov). Standard-of-care, first-line therapy for patients with advanced HER2+ gastric/gastroesophageal junction adenocarcinoma is chemotherapy plus trastuzumab, a monoclonal antibody (mAb) targeting HER2. Margetuximab is an Fc-optimized mAb that binds HER2. Retifanlimab, a humanized IgG4 mAb, binds to PD-1 and blocks its interaction with PD-L1/2. Tebotelimab, an IgG4κ bispecific DART® molecule, binds PD-1 and lymphocyte activation gene 3 concomitantly, disrupting these nonredundant inhibitory pathways to further restore exhausted T-cell function. Here, we describe the design and rationale of the randomized, open-label, Phase II/III MAHOGANY trial evaluating margetuximab plus retifanlimab with/without chemotherapy and margetuximab plus tebotelimab with chemotherapy in first-line unresectable metastatic/locally advanced gastroesophageal junction adenocarcinoma. Primary end points include objective response rate, overall survival and safety/tolerability. Clinical trial registration: NCT04082364 (ClinicalTrials.gov).Standard-of-care, first-line therapy for patients with advanced HER2+ gastric/gastroesophageal junction adenocarcinoma is chemotherapy plus trastuzumab, a monoclonal antibody (mAb) targeting HER2. Margetuximab is an Fc-optimized mAb that binds HER2. Retifanlimab, a humanized IgG4 mAb, binds to PD-1 and blocks its interaction with PD-L1/2. Tebotelimab, an IgG4κ bispecific DART® molecule, binds PD-1 and lymphocyte activation gene 3 concomitantly, disrupting these nonredundant inhibitory pathways to further restore exhausted T-cell function. Here, we describe the design and rationale of the randomized, open-label, Phase II/III MAHOGANY trial evaluating margetuximab plus retifanlimab with/without chemotherapy and margetuximab plus tebotelimab with chemotherapy in first-line unresectable metastatic/locally advanced gastroesophageal junction adenocarcinoma. Primary end points include objective response rate, overall survival and safety/tolerability. Clinical trial registration: NCT04082364 (ClinicalTrials.gov). Standard-of-care, first-line therapy for patients with advanced HER2+ gastric/gastroesophageal junction adenocarcinoma is chemotherapy plus trastuzumab, a monoclonal antibody (mAb) targeting HER2. Margetuximab is an Fc-optimized mAb that binds HER2. Retifanlimab, a humanized IgG4 mAb, binds to PD-1 and blocks its interaction with PD-L1/2. Tebotelimab, an IgG4κ bispecific DART molecule, binds PD-1 and lymphocyte activation gene 3 concomitantly, disrupting these nonredundant inhibitory pathways to further restore exhausted T-cell function. Here, we describe the design and rationale of the randomized, open-label, Phase II/III MAHOGANY trial evaluating margetuximab plus retifanlimab with/without chemotherapy and margetuximab plus tebotelimab with chemotherapy in first-line unresectable metastatic/locally advanced gastroesophageal junction adenocarcinoma. Primary end points include objective response rate, overall survival and safety/tolerability. |
| Author | Catenacci, Daniel V T Chung, Hyun Cheol Moehler, Markus Yoon, Harry H Kang, Yoon-Koo Rosales, Minori Shen, Lin |
| AuthorAffiliation | 6University Medical Center Mainz, Mainz 55131, Germany 4Mayo Clinic Cancer Center, Rochester, MN 55905, USA 7Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea 1Department of Medicine, Section of Hematology & Oncology, University of Chicago, Chicago, IL 60637, USA 5Peking University Cancer Hospital & Institute, Beijing 100142, China 2Clinical Research, MacroGenics, Inc., Rockville, MD 20850, USA 3Yonsei Cancer Center, University College of Medicine, Seoul 03722, Korea |
| AuthorAffiliation_xml | – name: 5Peking University Cancer Hospital & Institute, Beijing 100142, China – name: 1Department of Medicine, Section of Hematology & Oncology, University of Chicago, Chicago, IL 60637, USA – name: 6University Medical Center Mainz, Mainz 55131, Germany – name: 2Clinical Research, MacroGenics, Inc., Rockville, MD 20850, USA – name: 7Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea – name: 3Yonsei Cancer Center, University College of Medicine, Seoul 03722, Korea – name: 4Mayo Clinic Cancer Center, Rochester, MN 55905, USA |
| Author_xml | – sequence: 1 givenname: Daniel V T orcidid: 0000-0001-7517-8020 surname: Catenacci fullname: Catenacci, Daniel V T organization: Department of Medicine, Section of Hematology & Oncology, University of Chicago, Chicago, IL60637, USA – sequence: 2 givenname: Minori surname: Rosales fullname: Rosales, Minori organization: Clinical Research, MacroGenics, Inc., Rockville, MD20850, USA – sequence: 3 givenname: Hyun Cheol surname: Chung fullname: Chung, Hyun Cheol organization: Yonsei Cancer Center, University College of Medicine, Seoul03722, Korea – sequence: 4 givenname: Harry H surname: Yoon fullname: Yoon, Harry H organization: Mayo Clinic Cancer Center, Rochester, MN55905, USA – sequence: 5 givenname: Lin surname: Shen fullname: Shen, Lin organization: Peking University Cancer Hospital & Institute, Beijing100142, China – sequence: 6 givenname: Markus surname: Moehler fullname: Moehler, Markus organization: University Medical Center Mainz, Mainz55131, Germany – sequence: 7 givenname: Yoon-Koo surname: Kang fullname: Kang, Yoon-Koo organization: Asan Medical Center, University of Ulsan College of Medicine, Seoul05505, Korea |
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| Title | MAHOGANY: margetuximab combination in HER2+ unresectable/metastatic gastric/gastroesophageal junction adenocarcinoma |
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