AstraZeneca (AZ, NASDAQ: AZN) announced that Imfinzi (durvalumab) received National Medical Products Administration (NMPA) approval for patients with unresectable Stage III NSCLC who have no disease progression after platinum-based concurrent or sequential chemoradiotherapy and lack EGFR/ALK alterations, based on the PACIFIC-5 Phase 3 trial demonstrating a 25% reduction in disease progression or death risk.
Regulatory Milestone
Item
Detail
Product
Imfinzi (durvalumab)
Company
AstraZeneca (NASDAQ: AZN)
Agency
NMPA (China)
Approval Type
Expanded indication
Indication
Unresectable Stage III NSCLC post cCRT or sCRT (no EGFR/ALK alterations)
Study Basis
PACIFIC-5 Phase 3 trial
Primary Result
25% reduction in disease progression/death risk vs. placebo
Historical Context
First approved in China in 2019 for cCRT consolidation; now expands to sCRT patients
Drug Profile
Mechanism: Humanized PD-L1 monoclonal antibody that restores anti-tumor T‑cell activity
Innovation:First immunotherapy approved for Stage III NSCLC consolidation; now the first to cover both cCRT and sCRT patient populations
Clinical Differentiation: PACIFIC-5 subgroup analysis confirmed benefit regardless of chemoradiotherapy sequencing, addressing a previously underserved sCRT patient group (~30% of Stage III NSCLC patients)
Clinical Evidence – PACIFIC-5 Trial
Endpoint
Durvalumab vs. Placebo
Disease Progression/Death Risk Reduction
25% (HR = 0.75; p < 0.01)
Overall Survival Trend
Favorable (interim analysis)
cCRT Subgroup
Consistent benefit
sCRT Subgroup
Consistent benefit (key expansion)
Safety Profile
Manageable; consistent with prior PACIFIC data
Market Impact & Outlook
Metric
Value
China Stage III NSCLC Incidence
~85,000 new cases annually
Eligible for Consolidation
~60% (51,000 patients)
sCRT Patient Share
~30% (15,300 patients)
Current Durvalumab Sales (China)
¥2.1 billion (~$290 million)
Peak Sales Forecast (Expanded Indication)
¥3.5‑4.2 billion (~$480‑580 million) by 2028
Market Share Target
45‑50% of eligible Stage III NSCLC patients
Reimbursement Path: NRDL listing secured for cCRT indication; expansion for sCRT likely automatic under existing agreement
Competitive Moat:No direct competitors in sCRT consolidation; reinforces durvalumab’s leadership in Stage III NSCLC
Strategic Value: Strengthens AstraZeneca’s IO franchise in China, complementing Imfinzi’s approvals in extensive-stage SCLC and biliary tract cancer
Forward‑Looking Statements This brief contains forward‑looking statements regarding durvalumab’s commercial performance, market penetration, and regulatory exclusivity. Actual results may differ materially due to risks including competitive responses, reimbursement negotiations, and real‑world clinical adoption.-Fineline Info & Tech
By Fineline Cube 