Imfinzi by AstraZeneca is already on the list of achievements in the category of perioperative labels, and the new FDA label provides the drug with the name of the first and only immunotherapy to address the needs of patients with stomach cancer at the initial stage, before and after the surgery.
Imfinzi may also be given together with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) to adult patients with resectable, early-stage stage and locally advanced gastric and gastroesophageal junction (GEJ) squamous cell carcinomas. The approval specifically permits Imfinzi to be administered with chemotherapy before surgery, followed by after surgery with chemotherapy, and then finally on its own as a monotherapy.
The approval of Imfinzi with FLOT provides a new clinical paradigm to patients with early gastric and gastroesophageal junction cancers, and this approach offers a lasting benefit in survival, which improves with time, Dave Fredrickson, the executive vice president and head of the oncology hematology business unit at AZ, said in a Tuesday release.
The FDA used the phase 3 Matterhorn clinical trial of AZ, which it reported in June at the annual meeting of the American Society of Clinical Oncology in 2025. Imfinzi and FLOT before and after surgery reduced the risk of disease recurrence, progression, or death by 29% in the study of 948 patients’ stage 2-4a resectable cancers of the stomach and GEJ.
The results of Imfinzi in the first phase 3 trial of a first-line immunotherapy that show statistically significant improvements in event-free survival in the first-line environment of stomach cancer, AZ announced in a readout in March.
The overall survival analysis of Matterhorn, which was introduced at the European Society of Medical Oncology Congress last month, again confirmed the benefits of Imfinzi in perioperative stomach cancer with an estimated overall survival of Imfinzi-treated patients being 69 percent after three years, compared to the 62 percent in the FLOT-only arm.
Imfinzi and FLOT, to that end, showed that they have the ability to reduce the risk of death by 22 percent over chemotherapy alone, as AZ provided, and consistently, the survival difference was independent of PD-L1.
The Matterhorn data were groundbreaking in patients who have early gastric and gastroesophageal cancers, as recurrence is frequent and overall survival is poor despite curative-intent surgery and chemotherapy, as explained in a release about overall survival in October.
As these are the results, this new treatment must become the new standard of care in this curative-intent setting, Tabernero added.
According to AZ, gastric cancer is the fifth most common cancer across the globe and the fifth most common cause of cancer death, with a rising incidence among younger patients. The company estimated that 43,000 patients in the U.S., Europe, and Japan in 2025 would receive treatment for early-stage gastric or GEJ cancer using therapy.
Imfinzi is already establishing itself in the perioperative treatment sector, having already snatched perioperative awards in the early-stage resectable non-small cell lung cancer (NSCLC) and, in more recent times, in muscle-invasive bladder cancer (MIBC).
In response to the AZ Imfinzi bid and the associated trial design, the Oncologic Drugs Advisory Committee of the FDA unanimously recommended a redesign of perioperative clinical trial designs in NSCLC last year, where the specialists supported the standalone assessment of the value of each treatment phase.
In parallel, regulatory authorities in other regions may follow the FDA’s lead, potentially making this perioperative option accessible globally. For patients, this could mean improved long-term outcomes and a better chance at durable remission. With continuous monitoring, ongoing follow-up and real-world data, Imfinzi might become a cornerstone in early-stage gastric and GEJ cancer therapies.
As the field of oncology continues to evolve, the FDA approval of Imfinzi in early-stage gastric and GEJ cancer is expected to influence future trial designs across multiple tumor types. Clinicians note that when a therapy demonstrates strong perioperative benefits, regulatory bodies like the FDA often encourage broader investigation into similar approaches for other cancers with high recurrence rates. This may pave the way for additional immunotherapy-based regimens geared toward treating patients earlier in the disease course.
Industry analysts also point out that the FDA’s continued support for perioperative immunotherapy highlights the agency’s wider focus on improving long-term survival rather than solely short-term response outcomes.
With Imfinzi showing consistent performance across several indications, researchers anticipate a growing emphasis on early intervention strategies. This shift may ultimately improve patient access to life-extending therapies and encourage more streamlined development pathways for future oncology treatments.
