European regulators have taken a major step forward in gastric cancer treatment by recommending approval of Imfinzi. The therapy targets adults with resectable gastric and gastroesophageal junction (GEJ) cancers. This decision offers a new option for patients with limited treatment choices.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 29 January 2026. This recommendation follows compelling results from the MATTERHORN Phase III clinical trial. If the European Commission approves, Imfinzi plus FLOT chemotherapy will become the first immunotherapy-based perioperative gastric cancer treatment in the EU.
In the MATTERHORN trial, patients received Imfinzi (durvalumab) with the standard FLOT chemotherapy regimen, fluorouracil, leucovorin, oxaliplatin, and docetaxel, before and after surgery. Afterward, they received Imfinzi as monotherapy. This approach aims to shrink tumors before surgery and reduce recurrence after treatment.
During interim analysis, the Imfinzi regimen demonstrated a 29% reduction in disease progression, recurrence, or death compared with chemotherapy alone. These results highlight its value in strengthening current gastric cancer treatment strategies.
Final analysis revealed a 22% reduction in the risk of death for patients receiving Imfinzi plus FLOT. Approximately 69% of patients were alive at three years. In comparison, 62% survived in the chemotherapy-only group. This finding demonstrates long-term survival benefits for this new therapy.
Experts presented MATTERHORN data at high-profile oncology conferences. Peer-reviewed publications further confirmed clinical confidence in this advance in gastric and gastroesophageal junction (GEJ) cancer treatment.
Josep Tabernero, MD, PhD, principal investigator of the trial, called the CHMP recommendation a major step forward. He explained that patients historically face high recurrence rates and poor outcomes despite surgery and chemotherapy.
This breakthrough is particularly important given gastric cancer’s global impact. It ranks as the fifth leading cause of cancer death worldwide, with nearly one million new cases annually. Recurrence remains common, and five-year survival rates are low. More effective therapies are urgently needed.
Under the proposed regimen, patients receive Imfinzi plus FLOT before surgery (neoadjuvant therapy). After surgery, they continue the same combination (adjuvant therapy) and finish with Imfinzi monotherapy. This multi-phase approach aims to reduce tumor burden and improve survival outcomes.
The safety profile of Imfinzi plus FLOT was consistent with expectations. Severe adverse events and surgical completion rates were similar to chemotherapy alone. These results suggest that adding Imfinzi does not compromise patient tolerance or surgical eligibility.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, said the CHMP opinion brings the medical community closer to delivering this new gastric cancer treatment. She noted that more than two-thirds of patients were alive at three years with this regimen.
If the European Commission approves, clinical guidelines across EU member states are likely to change. Oncologists could adopt Imfinzi as a standard perioperative gastric cancer treatment for resectable, early-stage, and locally advanced cancers.
Beyond gastric cancer, Imfinzi has demonstrated benefits in other cancers, including non-small cell lung cancer and biliary tract cancer. Its growing indications show ongoing research and potential to improve outcomes across multiple tumor types.
Regulatory submissions for Imfinzi’s gastric cancer regimen are progressing globally, including in Japan. This trend indicates a worldwide effort to integrate immunotherapy-enhanced gastric cancer treatments into routine practice.
In summary, the CHMP recommendation marks a pivotal advance in gastric cancer treatment. Combining immunotherapy with established chemotherapy offers new hope for patients with resectable gastric and GEJ cancers across the European Union.
