The U.S. Food and Drug Administration (FDA) on Tuesday approved AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) for resectable, early-stage, and locally advanced gastric and gastroesophageal junction (GEJ) cancers.
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The approved regimen includes neoadjuvant (therapy before surgery) Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy.
The approval follows FDA's Priority Review and is based on event-free survival (EFS) and overall survival (OS) data from the MATTERHORN Phase 3 trial.
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Why It Matters?
Gastric cancer is the fifth leading cause of cancer death globally, with nearly one million people diagnosed each year. In 2024, there were roughly 6,500 drug-treated patients in the U.S. with early-stage and locally advanced gastric or GEJ cancer.
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "As the third U.S. approval for a perioperative Imfinzi-based regimen, this milestone further validates the perioperative approach and underscores our focus on bringing novel treatments to early-stage cancers where cure is the goal."
Data
In a planned interim analysis, patients treated with the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence, or death versus chemotherapy alone.
The estimated median EFS was not yet reached for the Imfinzi arm versus 32.8 months for the comparator arm.
An estimated 78.2% of patients treated with the Imfinzi-based perioperative regimen were event-free at one year, compared to 74.0% in the comparator arm; the estimated 24-month EFS rate was 67.4% versus 58.5%, respectively.
In the final OS analysis, results showed the Imfinzi and FLOT perioperative regimen reduced the risk of death by 22% compared with chemotherapy alone.
An estimated 69% of patients treated with the Imfinzi-based regimen were alive at three years compared with 62% in the FLOT-only arm.
With longer follow-up, the OS curves showed continued separation, signaling a greater magnitude of benefit over time for the Imfinzi-based regimen. An OS benefit was observed regardless of PD-L1 status.
AZN Price Action: AstraZeneca shares were down 0.59% at $92.69 at the time of publication on Tuesday. The stock is trading near its 52-week high of $93.41, according to Benzinga Pro data.
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