CAMBRIDGE, UK, March 16, 2026
AstraZeneca has received European Commission approval for Imfinzi (durvalumab) as the first and only perioperative immunotherapy for patients with resectable early-stage gastric and gastroesophageal junction (GEJ) cancers, marking a major advancement in cancer treatment. The approval is based on results from the Phase III MATTERHORN trial, which demonstrated statistically significant and clinically meaningful improvements in both event-free survival (EFS) and overall survival (OS), reinforcing Imfinzi’s role as a new standard of care in early-stage gastrointestinal oncology.
Phase III Data Demonstrates Significant Survival Benefit
The approval is supported by robust clinical evidence from the global, randomized, double-blind MATTERHORN Phase III trial, involving patients with Stage II–IVA gastric and GEJ cancers. Patients treated with the Imfinzi plus FLOT chemotherapy perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence, or death, compared to chemotherapy alone. Additionally, the regimen demonstrated a 22% reduction in the risk of death, highlighting its impact on long-term survival outcomes.
At key timepoints, the benefits were clear, with 78.2% of patients remaining event-free at one year compared to 74.0% in the control group, and 67.4% event-free at two years versus 58.5%, respectively. Importantly, approximately 69% of patients treated with the Imfinzi-based regimen were alive at three years, compared to 62% in the comparator arm. These findings indicate a sustained and increasing survival advantage over time, regardless of tumor PD-L1 status, demonstrating broad applicability across patient populations.
First Perioperative Immunotherapy Sets New Standard
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Imfinzi’s approval establishes it as the first perioperative immunotherapy regimen in the European Union for early-stage gastric and GEJ cancers, addressing a critical unmet need in a disease with high recurrence rates despite surgery and chemotherapy. The treatment protocol includes two cycles of Imfinzi combined with chemotherapy before and after surgery, followed by Imfinzi monotherapy, offering a comprehensive approach across the surgical timeline.
Gastric cancer remains a leading cause of cancer mortality globally, with nearly one million new cases diagnosed each year. Despite curative-intent surgery, a significant proportion of patients experience disease recurrence within the first year, underscoring the need for improved therapeutic strategies. The integration of immunotherapy into perioperative care represents a paradigm shift in treatment, enhancing the body’s immune response to target residual cancer cells and reduce recurrence risk.
The safety profile of the Imfinzi-based regimen was consistent with known data, with similar rates of Grade 3 or higher adverse events compared to chemotherapy alone, and no compromise in surgical completion rates, supporting its clinical feasibility and tolerability.
Regulatory and Global Impact on Oncology Treatment
The European approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and adds to Imfinzi’s expanding global footprint, with approvals already in the United States and other regions for this indication. Regulatory submissions are also ongoing in Japan and additional markets, reflecting a coordinated global strategy to expand access to this innovative therapy.
Imfinzi is a PD-L1 blocking monoclonal antibody that enhances immune system activity against tumors, forming the backbone of AstraZeneca’s immuno-oncology portfolio. Its application across multiple cancer types and stages highlights the growing importance of immunotherapy in redefining cancer care, particularly in earlier disease settings where the potential for cure is highest.
This approval also reinforces AstraZeneca’s broader commitment to advancing treatments in gastrointestinal cancers, an area with significant unmet medical need and high disease burden worldwide. By integrating innovative clinical strategies and combination therapies, the company continues to drive progress in improving survival outcomes for cancer patients.
The European Commission approval of Imfinzi as the first perioperative immunotherapy for early-stage gastric and GEJ cancers represents a landmark achievement in oncology, delivering clinically meaningful survival benefits and establishing a new standard of care. Supported by strong Phase III data, this development underscores the importance of clinical research, regulatory excellence, and innovative treatment approaches in transforming cancer outcomes. For the cGxP.wire audience, this milestone highlights the critical role of regulatory approvals, clinical evidence, and immunotherapy innovation in advancing global healthcare.
Source: Astrazeneca press release
