Journal
FUTURE ONCOLOGY
Volume 17, Issue 10, Pages 1155-1164Publisher
FUTURE MEDICINE LTD
DOI: 10.2217/fon-2020-1007
Keywords
checkpoint inhibitor; first-line therapy; gastric cancer; gastroesophageal adenocarcinoma; gastroesophageal junction cancer; HER2; immuno-oncology; I-O combination; LAG-3; PD-1
Categories
Funding
- MacroGenics, Inc.
- Bristol-Myers Squibb/Ono Pharmaceutical
- Foundation Medicine, Guardant Health
- Natera, Pieris Pharmaceuticals
- Amgen
- BeiGene
- Celltrion Healthcare
- Merck Sharp Dohme Corp.
- Taiho Pharmaceutical
- Gloria Pharma
- Lilly
- Merck Serono
- Beijing Xiantong Biomedical Technology
- Boehringer Ingelheim
- Arbeitsgemeinschaft Internistische Onkologie, German Ministry of Education and Research
- European Organisation for Research and Treatment of Cancer
- German Cancer Aid
- Falk Foundation
- MCI Group
- Pfizer
- Roche
- MacroGenics
- GlaxoSmithKline
- Incyte
- Beihai Kangcheng (Beijing) Medical Technology
- Jacobio Pharmaceuticals
- Qilu Pharmaceutical
- Zaiding Pharmaceutical (Shanghai)
- Arbeitsgemeinschaft Internistische Onkologie
- German Ministry of Education and Research
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This study describes the design and rationale of a clinical trial evaluating the use of margetuximab plus retifanlimab or margetuximab plus tebotelimab in unresectable metastatic/locally advanced gastric/gastroesophageal junction adenocarcinoma as first-line therapy. Primary endpoints include objective response rate, overall survival, and safety/tolerability.
Standard-of-care, first-line therapy for patients with advanced human epidermal growth factor receptor 2 (HER2)-positive 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 IgG4 kappa bispecific DART(R) 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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