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API CSV36행 · 4개 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
Overview
Program
Keytruda (pembrolizumab)Herceptin (trastuzumab)Tecentriq (atezolizumab)Padcev (enfortumab vedotin)
Overview
Company
MerckRoche / GenentechRoche / GenentechAstellas / Pfizer (Seagen)
Overview
Modality
ANTIBODYANTIBODYANTIBODYADC
Overview
Target
PD-1HER2PD-L1Nectin-4
Overview
Indication
Multiple solid tumorsHER2+ breast cancer, HER2+ gastric/GEJ adenocarcinomaNSCLC, SCLC, HCC, TNBC, urothelial carcinoma, and othersLocally advanced or metastatic urothelial carcinoma
Overview
Phase
APPROVEDAPPROVEDAPPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVEDAPPROVEDAPPROVED
Overview
Content status
Curated CoreCurated CoreCurated CoreCurated Core
Overview
Data Confidence
Data Confidence · HighData Confidence · HighData Confidence · HighData Confidence · High
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA 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.
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.
Positioning
Development positioning
Global IO standard1L standard of care in urothelial carcinoma with pembrolizumab.
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.
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.
PK/PD
Half-life
22 h4 h27 hADC ~3.4 days; free MMAE ~2.4 days
PK/PD
Species
Mouse, Radiographic response, ctDNA clearance in some tumorsMouse, OS in metastatic BCMouse, HumanCynomolgus monkey, ORR, PFS, OS
PK/PD
Animal (cat.)
Mouse, In vitroMouse, In vitroHuman, MouseHuman, NHP, In vitro
PK/PD
Experiment
PDPharmacokineticPDPharmacokinetic
Toxicology
Species
Cynomolgus monkey, Macaque, Mouse, RatMouse, RatCynomolgus monkey, Mouse, HumanCynomolgus monkey, Mouse, Rat
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.
Toxicology
CRS
N/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.
Clinical
Selected reported efficacy
ORR 38%ORR 91.2%ORR 67.7%
Clinical
Reported ORR
38%91.2%67.7% (EV + pembrolizumab)
Clinical
Reported PFS
1.712.5 mo vs 6.3 mo (chemo)
Clinical
Reported OS
7.631.5 mo vs 16.1 mo (chemo)
Clinical
Result source
ClinicalTrials.gov NCT02444741ClinicalTrials.gov NCT02149524ClinicalTrials.gov NCT04457778EV-302 / KEYNOTE-A39 (NCT04223856)
Clinical
Program phase
APPROVEDAPPROVEDAPPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed countsNo active/completed counts
Clinical
Trial ref
NCT02444741NCT02149524NCT04457778NCT04223856
Preclinical
Animal (cat.)
MouseHuman, Mouse, In vitro