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타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 다음 갱신 D-6 · 마지막 9월 2일

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항목
AntibodyCurated CoreFDAApproved
durvalumab (Imfinzi, MEDI4736)
AstraZeneca·PD-L1
750 trials·t½ ~21 days (10 mg/kg q2w historical; flat mg dosing per current label)
Overview
Program
Imfinzi (durvalumab)
Overview
Company
AstraZeneca
Overview
Modality
ANTIBODY
Overview
Target
PD-L1
Overview
Indication
NSCLC (Stage III consolidation), SCLC, biliary tract, HCC
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
novel small molecule A 2A R antagonist which inhibits downstream signaling and increases T cell function as well as a novel m
Positioning
Known limitation
escape detection by the immune system
MoA
Mechanism
Durvalumab inhibits PD-L1 binding to PD-1 and CD80 (B7.1), counteracting tumor immune evasion and enhancing cytotoxic T-lymphocyte activity.
MoA
Biomarker
Unresectable Stage III NSCLC post-cCRT (PACIFIC); PD-L1 in other tumors.
PK/PD
Half-life
~21 days (10 mg/kg q2w historical; flat mg dosing per current label)
PK/PD
Species
Mouse, OS and PFS benefit in PACIFIC, pCR rates in neoadjuvant trials
PK/PD
Animal (cat.)
Mouse, In vitro
PK/PD
Experiment
PD
Toxicology
Species
Cynomolgus monkey, Macaque, Mouse
Toxicology
Major finding
Immune-related AEs consistent with PD-(L)1 class; radiation pneumonitis overlap monitoring in Stage III NSCLC.
Toxicology
CRS
N/A
Clinical
Safety signal
Immune-related AEs consistent with PD-(L)1 class; radiation pneumonitis overlap monitoring in Stage III NSCLC.
Clinical
Reported ORR
0%
Clinical
Result source
ClinicalTrials.gov NCT04372927
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT04372927