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현재 선택: 5 · Data Tier에서 열림

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API CSV36행 · 5개 프로그램

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항목
AntibodyCurated CoreFDAApproved
pembrolizumab (Keytruda)
Merck·PD-1
1669 trials·t½ 22 h
AntibodyCurated CoreFDAApproved
trastuzumab (Herceptin, Ogivri, Herzuma)
Roche / Genentech·HER2
1100 trials·t½ 4 h
AntibodyCurated CoreFDAApproved
atezolizumab (Tecentriq, MPDL3280A)
Roche / Genentech·PD-L1
693 trials·t½ 27 h
ADCCurated CoreFDAApproved
enfortumab vedotin (Padcev, ASG-22ME, enfortumab-vedotin-ejfv)
Astellas / Pfizer (Seagen)·Nectin-4
201 trials·t½ ADC ~3.4 days; free MMAE ~2.4 days
AntibodyCurated CoreFDAApproved
zanidatamab (Ziihera, ZW25, zanidatamab-hrii)
Jazz Pharmaceuticals / Zymeworks·HER2 (biparatopic)
35 trials·t½ ~7 days
Overview
Program
Keytruda (pembrolizumab)Herceptin (trastuzumab)Tecentriq (atezolizumab)Padcev (enfortumab vedotin)Ziihera (zanidatamab)
Overview
Company
MerckRoche / GenentechRoche / GenentechAstellas / Pfizer (Seagen)Jazz Pharmaceuticals / Zymeworks
Overview
Modality
ANTIBODYANTIBODYANTIBODYADCANTIBODY
Overview
Target
PD-1HER2PD-L1Nectin-4HER2 (biparatopic)
Overview
Indication
Multiple solid tumorsHER2+ breast cancer, HER2+ gastric/GEJ adenocarcinomaNSCLC, SCLC, HCC, TNBC, urothelial carcinoma, and othersLocally advanced or metastatic urothelial carcinomaFirst-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancer
Overview
Phase
APPROVEDAPPROVEDAPPROVEDAPPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVEDAPPROVEDAPPROVEDAPPROVED
Overview
Content status
Curated CoreCurated CoreCurated CoreCurated CoreCurated Core
Overview
Data Confidence
Data Confidence · HighData Confidence · HighData Confidence · HighData Confidence · HighData Confidence · High
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approvedFDA approvedFDA approvedFDA approved
Positioning
Key differentiator
Broad tumor-agnostic biomarker strategies (MSI-H, TMB)novel bifunctional chelator (2E-C-NETA) for applications in 177 Lu-based TRTnovel agents have been approved in recent years (including systemic pembrolizumab, nogapendekin alfa inbakicept-pmln, N-803),Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue.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).
Positioning
Known limitation
Loss of antigen presentation (β2M, JAK1/2), alternate checkpoints (TIM-3, LAG-3), and immunosuppressive TME.resistance to trastuzumab-based targeted therapy and limited intratumoral antibody penetration continue to restrict clinical outcomesresistance to existing therapiesNectin-4 loss, MMAE efflux, and tubulin alterations.HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling.
Positioning
Development positioning
Global IO standard1L standard of care in urothelial carcinoma with pembrolizumab.Challenges the ToGA trastuzumab-chemo backbone in 1L HER2+ GEA; still the only HER2 agent with a dedicated BTC indication.
Technology
Payload
MMAE (monomethyl auristatin E, tubulin inhibitor)
Technology
Linker
Protease-cleavable mc-vc-PAB, DAR ~3.8
Technology
DAR
DAR 3.8
MoA
Mechanism
Pembrolizumab is an IgG4 humanized monoclonal antibody that binds PD-1 on T cells and blocks interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including antitumor response.Trastuzumab binds domain IV of HER2, inhibiting ligand-independent HER2 signaling, mediating ADCC via Fcγ receptors, and inducing internalization/degradation of HER2.Atezolizumab binds PD-L1 and blocks its interaction with PD-1 and B7.1 (CD80), enabling restoration of antitumor T-cell responses without direct PD-1 engagement on T cells.Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis.Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity.
MoA
Biomarker
PD-L1 CPS/TPS (tumor-specific), MSI-H/dMMR, TMB-H (≥10 mut/Mb), and tumor-type-specific biomarkers per label.HER2 IHC 3+ or ISH amplified (ASCO/CAP guidelines).PD-L1 IC/TC scoring in NSCLC and UC; tumor-type-specific thresholds.Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required.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+.
PK/PD
Half-life
22 h4 h27 hADC ~3.4 days; free MMAE ~2.4 days~7 days
PK/PD
Species
Mouse, Radiographic response, ctDNA clearance in some tumorsMouse, OS in metastatic BCMouse, HumanCynomolgus monkey, ORR, PFS, OSCynomolgus monkey, Human, OS and PFS in GEA, ORR and DOR in BTC
PK/PD
Animal (cat.)
Mouse, In vitroMouse, In vitroHuman, MouseHuman, NHP, In vitroHuman, NHP, In vitro
PK/PD
Experiment
PDPharmacokineticPDPharmacokineticpd
Toxicology
Species
Cynomolgus monkey, Macaque, Mouse, RatMouse, RatCynomolgus monkey, Mouse, HumanCynomolgus monkey, Mouse, RatHuman
Toxicology
Major finding
Immune-related AEsCardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos.Immune-mediated pneumonitis, hepatitis, colitis, endocrinopathies.Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring.Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class.
Toxicology
CRS
N/AN/AN/AN/AN/A
Clinical
Safety signal
Immune-related AEsCardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos.Immune-mediated pneumonitis, hepatitis, colitis, endocrinopathies.Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring.Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class.
Clinical
Selected reported efficacy
ORR 38%ORR 91.2%ORR 67.7%ORR 52%
Clinical
Reported ORR
38%91.2%67.7% (EV + pembrolizumab)52%
Clinical
Reported PFS
1.712.5 mo vs 6.3 mo (chemo)~5.5 mo
Clinical
Reported OS
7.631.5 mo vs 16.1 mo (chemo)15.54
Clinical
Result source
ClinicalTrials.gov NCT02444741ClinicalTrials.gov NCT02149524ClinicalTrials.gov NCT04457778EV-302 / KEYNOTE-A39 (NCT04223856)HERIZON-BTC-01 (NCT04466891)
Clinical
Program phase
APPROVEDAPPROVEDAPPROVEDAPPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed countsNo active/completed countsNo active/completed counts
Clinical
Trial ref
NCT02444741NCT02149524NCT04457778NCT04223856NCT04466891
Preclinical
Animal (cat.)
MouseHuman, Mouse, In vitroUnknown