Company: AZN
Filing Date: 2025-11-26
Form Type: 6-K
Source: 0001654954-25-013450
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-11-26
Form: 6-K
Chunk 2
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 as a caregiver to my father, I know that for too long patients diagnosed with early gastric or gastroesophageal junction cancer have faced a high risk of their cancer returning, even after undergoing surgery and therapy intended to cure it. Today's approval represents a major step forward in improving outcomes and offering renewed hope to those affected by this devastating disease."

In a planned interim analysis, patients treated with the Imfinzi -based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone (based on an EFS hazard ratio [HR] of 0.71; 95% confidence interval [CI] 0.58-0.86; p<0.001). Estimated median EFS was not yet reached for the Imfinzi arm versus 32.8 months for the comparator arm. An estimated 78.2% of patients treated with the Imfinzi -based perioperative regimen were event-free at one year, compared to 74.0% in the comparator arm; the estimated 24-month EFS rate was 67.4% versus 58.5%, respectively.

In the final OS analysis, results showed the Imfinzi and FLOT perioperative regimen reduced the risk of death by 22% compared with chemotherapy alone (based on a HR of 0.78; 95% CI 0.63-0.96; p=0.021). An estimated 69% of patients treated with the Imfinzi -based regimen were alive at three years compared with 62% in the FLOT-only arm. With longer follow-up, the OS curves showed continued separation, signaling a greater magnitude of benefit over time for the Imfinzi -based regimen. An OS benefit was observed regardless of PD-L1 status.

The safety profile for Imfinzi and FLOT chemotherapy was consistent with the known profiles of each medicine, and the percentage of patients that completed surgery was similar compared to chemotherapy alone. Grade 3 or higher adverse events due to any cause were similar between the two arms (71.6% for Imfinzi and FLOT arm; 71.2% for FLOT-only arm).

The US regulatory submission was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, the Imfinzi and FLOT perioperative regimen is also under review by regulatory authorities in Australia, Canada, and Switzerland for the same indication. Regulatory applications