AstraZeneca Announces Final OS Results from Phase III MATTERHORN Trial: Durvalumab-Based Perioperative Therapy Reduces Death Risk by 22% in Resectable Gastric and GEJ Adenocarcinoma

From October 17 to 21 local time, the 2025 European Society for Medical Oncology（ESMO）The conference was grandly held in Berlin, Germany. AstraZenecaAnnounced Phase III Clinical StudyMATTERHORN TheFinal Overall Survival（OS）Results.

MATTERHORN is aRandomized, Double-blind, Placebo-controlled Phase III Study,Aiming atEvaluation of Durvalumab Combined with FLOT(Fluorouracil, Calcium Folinate, Oxaliplatin, and Docetaxel)Chemotherapy for resectable early and locally advancedAdenocarcinoma of the Stomach and Gastroesophageal Junction（GEJ）PatientPerioperative TreatmentClinical benefits in China.

In the trial,948 patients were randomly assigned to receive a fixed dose of 1500 mgDurvalumabCombined FLOT chemotherapy or placebo combined with FLOT chemotherapy, administered once every four weeks for a total of two cycles. Post-surgery treatment is given every four weeks.DurvalumabOr placebo treatment, for up to 12 cycles(Including 2 cycles ofDurvalumabOr placebo combined with FLOT chemotherapy, and an additional 10 cycles ofDurvalumabOr placebo monotherapy)。

In the final OS analysis, the results showed that, compared with chemotherapy alone, the perioperative treatment regimen based on durvalumabReduced the risk of death by 22%（HR=0.78；p=0.021）. The two treatment groupsMedian OS has not been reached yet.. In the treatment regimen group based on Durvalumab, the patientsThe three-year survival rate is estimated to be 69%., while the standalone FLOT group was 62%.

An additional analysis of MATTERHORN showed that pathological outcomes were associated with event-free survival.（EFS）The correlation suggests that any degree of pathological response in the durvalumab group is associated with improved EFS compared to the control group.(Pathological complete response risk ratio 0.29; Major pathological response risk ratio 0.32; Any pathological response risk ratio 0.60)EFS was improved in patients with different lymph node statuses at the time of surgery.(Risk ratio without lymph node involvement 0.74; Risk ratio with lymph node involvement 0.77)。

The previously announced interim analysis of the key primary endpoint EFS showed that patients receiving the durvalumab perioperative treatment regimen had improved outcomes compared to chemotherapy alone,29% reduction in the risk of disease progression, recurrence, or death(Based on EFS hazard ratio 0.71; p<0.001)。

In terms of safety, the safety profile of durvalumab in combination with FLOT chemotherapy was consistent with the known characteristics of the drugs, and the proportion of patients completing surgery was similar to that of chemotherapy alone. The incidence of grade 3 or higher adverse events due to any cause was similar in both groups.

Screenshot source: Insight database

Sophie Kao, Executive Vice President of AstraZeneca PLC and Head of Global Oncology R&D（Susan Galbraith）"The overall survival results of durvalumab indicate a 22% reduction in the risk of death for patients with early-stage gastric cancer and gastroesophageal junction adenocarcinoma, which is expected to transform the treatment landscape in this disease area. AsThe first perioperative immunotherapy regimen in this field to significantly extend patient survivalThe MATTERHORN trial illustrates our strategy of introducing innovative therapies at an early stage of the disease, where a cure is possible."

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