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AstraZeneca's Imfinzi Regimen Approved in US for Early-Stage Stomach Cancer
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AstraZeneca's Imfinzi Regimen Approved in US for Early-Stage Stomach Cancer
Nov 25, 2025 12:23 PM

03:08 PM EST, 11/25/2025 (MT Newswires) -- AstraZeneca ( AZN ) said Tuesday its Imfinzi in combination with standard chemotherapy was approved in the US to treat adults with early-stage and locally advanced gastric and gastroesophageal junction cancers.

The approval follows Priority Review by the Food and Drug Administration and is based on event-free survival and overall survival data from a phase 3 trial, the company said.

A planned interim analysis showed that the drug regimen resulted in a 29% reduction in the risk of disease progression, recurrence or death compared with chemotherapy alone, the company said. About 78.2% of patients were event-free at one year, and the estimated two-year EFS rate was 67.4%, according to a statement.

Survival data analysis showed that the treatment lowered death risks by 22% compared with chemotherapy alone, the company said. Around 69% of patients treated with the drug regimen were alive at three years, the company said.

The safety profile was consistent with the known profiles of each medicine, according to the company.

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