타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 5개 · 임상 갱신 필요 5개 · Data Tier에서 열림
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | zanidatamab (Ziihera, ZW25, zanidatamab-hrii) Jazz Pharmaceuticals / Zymeworks·HER2 (biparatopic) 35 trials | tislelizumab (Tevimbra, BGB-A317, tislelizumab-jsgr) BeOne Medicines·PD-1 213 trials·t½ ~20 days class range | zolbetuximab (Vyloy, IMAB362, zolbetuximab-clzb, claudiximab) Astellas·CLDN18.2 (claudin-18.2) 26 trials | ||
|---|---|---|---|---|---|
Overview Program | Herceptin (trastuzumab) | Enhertu (fam-trastuzumab deruxtecan-nxki) | Ziihera (zanidatamab) | Tevimbra (tislelizumab) | Vyloy (zolbetuximab) |
Overview Company | Roche / Genentech | Daiichi Sankyo / AstraZeneca | Jazz Pharmaceuticals / Zymeworks | BeOne Medicines | Astellas |
Overview Modality | ANTIBODY | ADC | ANTIBODY | ANTIBODY | ANTIBODY |
Overview Target | HER2 | HER2 | HER2 (biparatopic) | PD-1 | CLDN18.2 (claudin-18.2) |
Overview Indication | HER2+ breast cancer, HER2+ gastric/GEJ adenocarcinoma | HER2-positive breast cancer (including regimen-specific first-line and early-stage indications); HER2-low/ultralow breast cancer, HER2-positive gastric cancer, HER2-mutant NSCLC and HER2-positive solid tumors: consult the current US label | First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancer | Esophageal squamous cell carcinoma, gastric/GEJ adenocarcinoma, and first-line HER2-positive GEA with zanidatamab and chemotherapy | CLDN18.2-positive HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma |
Overview Phase | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core | Curated Core | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved | FDA approved | FDA approved | FDA approved |
Positioning Key differentiator | novel bifunctional chelator (2E-C-NETA) for applications in 177 Lu-based TRT | High DAR (~8), bystander effect, HER2-low activity | Dual-epitope binding drives receptor clustering, faster internalization, and stronger signaling blockade than either monoclonal alone. In GEA the label splits IHC 3+ (chemo doublet) from IHC 3+ or 2+/ISH+ (chemo + Tevimbra). | Not a Keytruda substitute. The 2026 GEA label is a HER2-selected triplet with zanidatamab, not a PD-L1-unselected 1L PD-1 row. | Exploits a tight-junction protein that only becomes accessible after malignant transformation, creating tumor selectivity without a novel modality. |
Positioning Known limitation | resistance to trastuzumab-based targeted therapy and limited intratumoral antibody penetration continue to restrict clinical outcomes | HER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation. | HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling. | Antigen-presentation loss, alternate checkpoints, immunosuppressive TME. | CLDN18.2 heterogeneity and loss under treatment pressure. |
Positioning Development positioning | — | Indication- and regimen-specific; includes 1L + pertuzumab in HER2-positive metastatic breast cancer | 1L GEA with fluoropyrimidine-platinum ± Tevimbra; 2L+ BTC monotherapy | 1L–2L gastroesophageal, regimen-dependent | 1L with fluoropyrimidine and platinum chemotherapy |
Technology Payload | — | DXd (topo-I inhibitor) | — | — | — |
Technology Linker | — | Cleavable tetrapeptide | — | — | — |
MoA Mechanism | Trastuzumab binds domain IV of HER2, inhibiting ligand-independent HER2 signaling, mediating ADCC via Fcγ receptors, and inducing internalization/degradation of HER2. | Fam-trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate: humanized anti-HER2 IgG1 linked via a cleavable tetrapeptide linker to DXd, a membrane-permeable topoisomerase I inhibitor. After binding HER2 on tumor cells, the conjugate is internalized; lysosomal proteases cleave the linker and release DXd, causing DNA damage and apoptosis. Released DXd can exert a bystander effect in neighboring cells. | Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity. | Binds PD-1 on T cells, blocking PD-L1/PD-L2 engagement and restoring antitumor T-cell activity. Fc silencing is intended to avoid macrophage-mediated T-cell clearance. | Binds CLDN18.2 on gastric tumor cells and kills them through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. |
MoA Biomarker | HER2 IHC 3+ or ISH amplified (ASCO/CAP guidelines). | HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2). | GEA: PATHWAY 4B5 IHC and VENTANA Dual ISH. IHC 3+ for chemo doublet; IHC 3+ or IHC 2+/ISH+ when Tevimbra is added. BTC: HER2 IHC 3+. | PD-L1 and tumor type on older labels; HER2 IHC/ISH when given with Ziihera. | CLDN18.2 IHC with ≥75% of tumor cells at moderate-to-strong membranous staining. |
PK/PD Half-life | — | — | — | ~20 days class range | — |
PK/PD Species | — | — | — | OS/PFS, radiographic response | — |
PK/PD Animal (cat.) | — | — | — | Human | — |
Toxicology Species | Rat | Cynomolgus monkey, NHP, Rat, Hamster | — | — | — |
Toxicology Animal (cat.) | — | NHP | — | — | — |
Toxicology Major finding | Cardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos. | ILD-like lung findings at high exposure | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled. | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. |
Toxicology CRS | N/A | Minimal | N/A | N/A | N/A |
Toxicology NOAEL | — | 10 mg/kg | — | — | — |
Clinical Safety signal | Cardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos. | ILD-like lung findings at high exposure | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled. | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. |
Clinical Selected reported efficacy | — | ORR 87% | — | — | — |
Clinical Reported ORR | — | 87% vs 81% (THP) | — | — | — |
Clinical Reported PFS | — | 40.7 months vs 26.9 months (THP) | — | — | — |
Clinical Reported OS | — | Immature at the reported PFS analysis | — | — | — |
Clinical Result source | — | FDA label 2026, Table 28 — DESTINY-Breast09 (NCT04784715) | — | — | — |
Clinical Program phase | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts | No active/completed counts | — | No active/completed counts |
Clinical Trial ref | — | NCT04784715 | — | — | — |
Preclinical Animal (cat.) | Mouse, In vitro | Human, Mouse, In vitro | — | — | — |
타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 5개 · 임상 갱신 필요 5개 · Data Tier에서 열림
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | zanidatamab (Ziihera, ZW25, zanidatamab-hrii) Jazz Pharmaceuticals / Zymeworks·HER2 (biparatopic) 35 trials | tislelizumab (Tevimbra, BGB-A317, tislelizumab-jsgr) BeOne Medicines·PD-1 213 trials·t½ ~20 days class range | zolbetuximab (Vyloy, IMAB362, zolbetuximab-clzb, claudiximab) Astellas·CLDN18.2 (claudin-18.2) 26 trials | ||
|---|---|---|---|---|---|
Overview Program | Herceptin (trastuzumab) | Enhertu (fam-trastuzumab deruxtecan-nxki) | Ziihera (zanidatamab) | Tevimbra (tislelizumab) | Vyloy (zolbetuximab) |
Overview Company | Roche / Genentech | Daiichi Sankyo / AstraZeneca | Jazz Pharmaceuticals / Zymeworks | BeOne Medicines | Astellas |
Overview Modality | ANTIBODY | ADC | ANTIBODY | ANTIBODY | ANTIBODY |
Overview Target | HER2 | HER2 | HER2 (biparatopic) | PD-1 | CLDN18.2 (claudin-18.2) |
Overview Indication | HER2+ breast cancer, HER2+ gastric/GEJ adenocarcinoma | HER2-positive breast cancer (including regimen-specific first-line and early-stage indications); HER2-low/ultralow breast cancer, HER2-positive gastric cancer, HER2-mutant NSCLC and HER2-positive solid tumors: consult the current US label | First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancer | Esophageal squamous cell carcinoma, gastric/GEJ adenocarcinoma, and first-line HER2-positive GEA with zanidatamab and chemotherapy | CLDN18.2-positive HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma |
Overview Phase | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core | Curated Core | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved | FDA approved | FDA approved | FDA approved |
Positioning Key differentiator | novel bifunctional chelator (2E-C-NETA) for applications in 177 Lu-based TRT | High DAR (~8), bystander effect, HER2-low activity | Dual-epitope binding drives receptor clustering, faster internalization, and stronger signaling blockade than either monoclonal alone. In GEA the label splits IHC 3+ (chemo doublet) from IHC 3+ or 2+/ISH+ (chemo + Tevimbra). | Not a Keytruda substitute. The 2026 GEA label is a HER2-selected triplet with zanidatamab, not a PD-L1-unselected 1L PD-1 row. | Exploits a tight-junction protein that only becomes accessible after malignant transformation, creating tumor selectivity without a novel modality. |
Positioning Known limitation | resistance to trastuzumab-based targeted therapy and limited intratumoral antibody penetration continue to restrict clinical outcomes | HER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation. | HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling. | Antigen-presentation loss, alternate checkpoints, immunosuppressive TME. | CLDN18.2 heterogeneity and loss under treatment pressure. |
Positioning Development positioning | — | Indication- and regimen-specific; includes 1L + pertuzumab in HER2-positive metastatic breast cancer | 1L GEA with fluoropyrimidine-platinum ± Tevimbra; 2L+ BTC monotherapy | 1L–2L gastroesophageal, regimen-dependent | 1L with fluoropyrimidine and platinum chemotherapy |
Technology Payload | — | DXd (topo-I inhibitor) | — | — | — |
Technology Linker | — | Cleavable tetrapeptide | — | — | — |
MoA Mechanism | Trastuzumab binds domain IV of HER2, inhibiting ligand-independent HER2 signaling, mediating ADCC via Fcγ receptors, and inducing internalization/degradation of HER2. | Fam-trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate: humanized anti-HER2 IgG1 linked via a cleavable tetrapeptide linker to DXd, a membrane-permeable topoisomerase I inhibitor. After binding HER2 on tumor cells, the conjugate is internalized; lysosomal proteases cleave the linker and release DXd, causing DNA damage and apoptosis. Released DXd can exert a bystander effect in neighboring cells. | Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity. | Binds PD-1 on T cells, blocking PD-L1/PD-L2 engagement and restoring antitumor T-cell activity. Fc silencing is intended to avoid macrophage-mediated T-cell clearance. | Binds CLDN18.2 on gastric tumor cells and kills them through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. |
MoA Biomarker | HER2 IHC 3+ or ISH amplified (ASCO/CAP guidelines). | HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2). | GEA: PATHWAY 4B5 IHC and VENTANA Dual ISH. IHC 3+ for chemo doublet; IHC 3+ or IHC 2+/ISH+ when Tevimbra is added. BTC: HER2 IHC 3+. | PD-L1 and tumor type on older labels; HER2 IHC/ISH when given with Ziihera. | CLDN18.2 IHC with ≥75% of tumor cells at moderate-to-strong membranous staining. |
PK/PD Half-life | — | — | — | ~20 days class range | — |
PK/PD Species | — | — | — | OS/PFS, radiographic response | — |
PK/PD Animal (cat.) | — | — | — | Human | — |
Toxicology Species | Rat | Cynomolgus monkey, NHP, Rat, Hamster | — | — | — |
Toxicology Animal (cat.) | — | NHP | — | — | — |
Toxicology Major finding | Cardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos. | ILD-like lung findings at high exposure | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled. | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. |
Toxicology CRS | N/A | Minimal | N/A | N/A | N/A |
Toxicology NOAEL | — | 10 mg/kg | — | — | — |
Clinical Safety signal | Cardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos. | ILD-like lung findings at high exposure | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled. | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. |
Clinical Selected reported efficacy | — | ORR 87% | — | — | — |
Clinical Reported ORR | — | 87% vs 81% (THP) | — | — | — |
Clinical Reported PFS | — | 40.7 months vs 26.9 months (THP) | — | — | — |
Clinical Reported OS | — | Immature at the reported PFS analysis | — | — | — |
Clinical Result source | — | FDA label 2026, Table 28 — DESTINY-Breast09 (NCT04784715) | — | — | — |
Clinical Program phase | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts | No active/completed counts | — | No active/completed counts |
Clinical Trial ref | — | NCT04784715 | — | — | — |
Preclinical Animal (cat.) | Mouse, In vitro | Human, Mouse, In vitro | — | — | — |
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