By Fineline Cube 
AstraZeneca (AZ, NASDAQ: AZN) announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Imfinzi (durvalumab) combined with FLOT chemotherapy for adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The perioperative regimen includes neoadjuvant and adjuvant Imfinzi plus chemotherapy followed by Imfinzi monotherapy.
Regulatory Milestone & Clinical Basis
| Item | Detail |
|---|---|
| Company | AstraZeneca (NASDAQ: AZN) |
| Drug | Imfinzi (durvalumab) |
| Combination | FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, docetaxel) |
| Indication | Resectable gastric/GEJ cancers (Stages II, III, IVA) |
| Regulatory Body | EMA CHMP |
| Recommendation | Positive opinion for approval |
| Clinical Basis | MATTERHORN Phase 3 trial |
MATTERHORN Trial Key Efficacy Data
| Endpoint | Imfinzi + FLOT | Chemotherapy Alone | Result |
|---|---|---|---|
| EFS Risk Reduction | — | — | 29% reduction (P < 0.05) |
| Median EFS | Not reached | 32.8 months | Significant improvement |
| OS Risk Reduction | — | — | 22% reduction (3‑year OS: 69% vs 62%) |
| Safety Profile | Consistent with known profiles | — | Similar surgery completion rate |
Mechanism & Treatment Regimen
- Perioperative Approach: Neoadjuvant Imfinzi + FLOT → Surgery → Adjuvant Imfinzi + FLOT → Imfinzi monotherapy
- Mechanism: PD‑L1 inhibition enhances anti‑tumor immune response, reducing risk of recurrence
- Clinical Advantage: First perioperative immunotherapy regimen to show OS benefit in resectable gastric cancer
Market Impact & Commercial Outlook
- EU Gastric Cancer Market: Estimated €1.5 billion by 2028; resectable stage patients represent 40% of new diagnoses
- Competitive Landscape: Competes with CheckMate‑649 (Opdivo + chemo) and KEYNOTE‑859 (Keytruda + chemo); perioperative Imfinzi offers differentiated treatment duration
- Strategic Value: Expands Imfinzi’s oncology footprint beyond lung cancer; validates perioperative immuno‑oncology approach
- Revenue Potential: Analysts project €300–500 million peak annual EU sales for gastric/GEJ indication by 2030
- Global Development: US FDA submission under evaluation; China NDA planned for 2027
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory approval timelines, commercial expectations, and revenue projections for Imfinzi. Actual results may differ due to EMA review outcomes, competitive dynamics, and market access negotiations.-Fineline Info & Tech