Table 4.
Investigational monoclonal antibodies in late-stage clinical studies for cancer indications.
| Primary sponsoring company | INN or code name | Molecular format | Target(s) | Most advanced phase | Pivotal Phase 2, Phase 2/3 or 3 indications |
|---|---|---|---|---|---|
| TG Therapeutics | Ublituximab | Chimeric IgG1 | CD20 | Phase 3 | Chronic lymphocytic leukemia |
| ADC Therapeutics Sarl | Loncastuximab tesirine | Humanized IgG1 ADC | CD19 | Pivotal Phase 2 | Diffuse large B-cell lymphoma |
| Hoffmann-La Roche | Polatuzumab vedotin | Humanized IgG1 ADC | CD79b | Phase 3 | Diffuse large B-cell lymphoma |
| Pfizer | Utomilumab | Human IgG2 | 4-1BB (CD137) | Phase 3 | Diffuse large B-cell lymphoma |
| MorphoSys | XMAB-5574, MOR208 | Humanized IgG1 | CD19 | Phase 2/3 | Diffuse large B-cell lymphoma |
| Sanofi | Isatuximab | Humanized IgG1 | CD38 | Phase 3 | Multiple myeloma |
| Jiangsu HengRui Medicine Co., Ltd | Camrelizumab | Humanized IgG4 | PD-1 | Phase 3; regulatory review in China | Hodgkin’s lymphoma, hepatocellular carcinoma |
| Actinium Pharmaceuticals | I-131-BC8, Iomab-B | Murine IgG1, radio-labeled | CD45 | Phase 3 | Ablation of bone marrow prior to hematopoietic cell transplantation in AML patients |
| Tracon | Carotuximab | Chimeric IgG1 | Endoglin | Phase 3 | Angiosarcoma |
| Alphamab Oncology | KN035 | mAb, single domain | PD-L1 | Phase 3 | Bile tract carcinoma |
| Viventia Bio | Oportuzumab monatox | Humanized scFv immunotoxin | EpCAM | Phase 3 | Bladder cancer |
| Bio-Thera Solutions | BAT8001 | Humanized IgG1 ADC | HER2 | Phase 3 | Breast cancer |
| Synthon Biopharmaceuticals BV | (vic-)trastuzumab duocarmazine | Humanized IgG1 ADC | HER2 | Phase 3 | Breast cancer |
| MacroGenics | Margetuximab | Chimeric IgG1 | HER2 | Phase 3 | Breast cancer |
| Daiichi Sankyo | Trastuzumab deruxtecan | Humanized ADC | HER2 | Phase 3 | Breast cancer, HER2+ gastric or gastroesophageal junction adenocarcinoma |
| Five Prime Therapeutics, Zai Lab Limited | Bemarituzumab | Humanized IgG1 | FGFR2b | Phase 3 | Gastric and gastro-esophageal junction adenocarcinoma |
| Astellas | Zolbetuximab, claudiximab | Chimeric IgG1 | Claudin-18.2 | Phase 3 | Gastric and gastro-esophageal junction adenocarcinoma |
| Gilead Sciences | Andecaliximab | Humanized IgG4 | MMP9 | Phase 3 | Gastric cancer or gastroesophageal junction adenocarcinoma |
| AbbVie | Depatuxizumab mafodotin | IgG1 ADC | EGFR | Phase 2b/3 | Glioblastoma |
| Y-mabs Therapeutics | Naxitamab | Humanized mAb | GD2 | Phase 3 | High risk neuroblastoma and refractory osteomedullary disease |
| Bristol-Myers Squibb | Relatlimab (BMS-986016) | Human mAb | LAG-3 | Phase 2/3 | Melanoma |
| Biocad | BCD-100 | Human mAb | PD-1 | Phase 2/3 | Melanoma |
| Novartis | Spartalizumab, PDR001 | Humanized IgG4 | PD-1 | Phase 3 | Melanoma |
| Philogen SpA | L19IL2 + L19TNF | scFv conjugates | Fibronectin extra-domain B | Phase 3 | Melanoma |
| Y-mAbs Therapeutics | 131I-omburtamab | Murine mAb, radiolabeled | B7-H3 | Phase 2/3 | Neuroblastoma central nervous system/leptomeningeal metastases |
| BeiGene | Tislelizumab (BGB-A317) | Humanized mAb | PD-1 | Phase 3; regulatory review in China | Non-small cell lung cancer, Hodgkin’s lymphoma |
| Innovent Biologics (Suzhou) Co. Ltd. | IBI308 | Human mAb | PD-1 | Phase 3; regulatory review in China | Squamous cell non-small cell lung cancer |
| CStone Pharmaceuticals | CS1001 | Human | PD-L1 | Phase 3 | Non-small cell lung cancer |
| AstraZeneca/MedImmune LLC | Tremelimumab | Human IgG2 | CTLA4 | Phase 3 | Non-small cell lung, head & neck, urothelial cancer |
| Tesaro, Inc. | TSR-042 | Humanized mAb | PD-1 | Phase 3 | Ovarian cancer |
| ImmunoGen | Mirvetuximab soravtansine | IgG1 ADC | Folate receptor 1 | Phase 3 | Ovarian cancer |
| AbbVie | Rovalpituzumab tesirine | Humanized IgG1 ADC | DLL3 | Phase 3 | Small cell lung cancer |
| Seattle Genetics | Enfortumab vedotin | Human IgG1 ADC | Nectin 4 | Phase 3 | Urothelial cancer |
Data available as of November 30, 2018. Abbreviations: ADC, antibody drug conjugate; CTLA-4, cytotoxic T-lymphocyte–associated antigen 4; DLL3, delta-like protein 3; EGFR, epidermal growth factor receptor; EpCAM, epithelial cell adhesion molecule; FGFR2, fibroblast growth factor receptor 2; HER2, human epidermal growth factor receptor-2; MMP-9, matrix metallopeptidase 9; PD-1, programmed cell death 1; PD-L1, programmed death ligand-1.