Investing.com -- AstraZeneca’s (LON:AZN) cancer drug Imfinzi (durvalumab) has been approved in the United States as a treatment for adults with certain types of stomach and gastroesophageal junction (GEJ) cancers that can be surgically removed.
The drug is used along with standard chemotherapy before and after surgery, and then by itself after surgery, the drugmaker said on Wednesday.
The approval is based on results from the Phase III MATTERHORN trial, which found that patients who received Imfinzi with chemotherapy were 29% less likely to have their cancer return, get worse, or die compared to those who received chemotherapy alone.
The trial also showed a 22% lower risk of death for patients on the Imfinzi-based treatment. About 69% of patients on the new regimen were alive three years after treatment, compared with 62% on chemotherapy alone.
The MATTERHORN trial included 948 patients from 176 centers across 20 countries. Patients received Imfinzi with chemotherapy for a few cycles before surgery, followed by additional cycles of the drug with chemotherapy, and then Imfinzi alone for up to 10 cycles after surgery.
The trial measured how long patients stayed free from disease returning or worsening and overall survival.
The safety of the Imfinzi-based treatment was similar to chemotherapy alone, with serious side effects occurring in about 72% of patients in both groups. Most patients were still able to complete their planned surgeries.
Stomach cancer is the fifth leading cause of cancer deaths worldwide, with nearly one million new cases each year.
Even with surgery and chemotherapy, the cancer often comes back, and fewer than half of patients survive for five years after diagnosis. In 2024, around 6,500 patients in the U.S. were treated with drugs for early-stage stomach or GEJ cancer.
The FDA reviewed Imfinzi through Project Orbis, which allows cancer drugs to be evaluated simultaneously in multiple countries.
The treatment is also under review in Australia, Canada, Switzerland, the European Union, Japan, and other countries.
Imfinzi works by helping the immune system recognize and attack cancer cells. It is already approved for several other cancers, including liver, bile duct, lung, and bladder cancers.