(Alliance News) - AstraZeneca PLC on Sunday said Imfinzi has been approved in the EU as the first and only perioperative immunotherapy for patients with early gastric and gastroesophageal cancers.

The Cambridge, England-based pharmaceutical company said the approval by the European Commission followed the positive opinion of the Committee for Medicinal Products for Human Use based on results from the Matterhorn phase three trial that demonstrated significant and clinically meaningful improvements in event-free survival and overall survival.

Imfinzi is a human monoclonal antibody developed by AstraZeneca that received its first approval in 2017 and is now being tested, as both a monotherapy and in combination, for the treatment of other forms of cancer.

"The regimen includes two cycles of Imfinzi in combination with chemotherapy before and after surgery, followed by Imfinzi monotherapy," AstraZeneca explained.

According to AstraZeneca, gastric cancer is the fifth leading cause of cancer death around the world, with almost one million people diagnosed annually.

In 2024, there were 15,500 drug-treated patients with early-stage and locally advanced gastric or gastroesophageal junction cancer in the EU alone.

Josep Tabernero, principal investigator, Vall d'Hebron University Hospital, said: "Despite curative-intent surgery and chemotherapy, patients with resectable gastric and gastroesophageal cancers still face high recurrence rates and an urgent need for improved long-term survival.

"In Matterhorn, nearly 70 per cent of patients were still alive three years after treatment with the durvalumab-based perioperative regimen. This EU approval brings patients the first immunotherapy regimen to extend survival in this early setting and is poised to become the new standard of care."

Dave Fredrickson, executive vice president, Oncology Haematology Business Unit, said: "This approval marks our third perioperative approval in Europe for an Imfinzi-based regimen, underscoring AstraZeneca's commitment to transforming outcomes in early-stage disease, where cure is possible."

AstraZeneca shares closed down 0.2% at 14,334.00 pence in London on Friday.

By Elijah Dale, Alliance News senior reporter Asia-Pacific

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