WILMINGTON, DE — AstraZeneca secured U.S. approval for its IMFINZI (durvalumab) regimen in combination with FLOT chemotherapy for early-stage and locally advanced gastric and gastroesophageal junction cancers, marking the first immunotherapy cleared in the neoadjuvant setting for these tumor types.
The Food and Drug Administration granted the approval following a Priority Review, basing its decision on results from the Phase III MATTERHORN trial. The data showed a 29 percent reduction in the risk of progression, recurrence, or death and a 22 percent reduction in the risk of death compared with chemotherapy alone. AstraZeneca said the benefits grew over time, signaling a durable advantage for patients treated before and after surgery with the durvalumab-based regimen.
The approved treatment plan includes IMFINZI plus chemotherapy ahead of surgery, continued combination therapy following surgery, and IMFINZI monotherapy thereafter.
Gastric cancer remains a major global burden, with nearly one million diagnoses each year. In the U.S., roughly 6,500 patients were treated in 2024 for early-stage or locally advanced gastric or GEJ cancers.
Dave Fredrickson, executive vice president of AstraZeneca’s oncology and hematology business, said the decision supports a broader shift toward perioperative immunotherapy. He described the regimen as a new clinical paradigm, adding that it is now the company’s third perioperative IMFINZI-based approval in the United States.
Yelena Y. Janjigian, chief attending physician of gastrointestinal medical oncology at Memorial Sloan Kettering Cancer Center and principal investigator in MATTERHORN, said the results establish a new standard of care. She noted that nearly 70 percent of patients receiving the durvalumab regimen were alive three years after treatment, with the survival benefit consistent across PD-L1 status.
Patient advocates also highlighted the significance of the approval. Aki Smith, founder of Hope for Stomach Cancer, said the decision offers renewed optimism for families confronting a disease long associated with high recurrence rates even after surgery.
In the interim MATTERHORN analysis, the IMFINZI combination achieved a hazard ratio of 0.71 for event-free survival, with median EFS not yet reached. At two years, 67.4 percent of patients in the IMFINZI arm were event-free, compared with 58.5 percent in the comparator group. Final overall-survival results showed a hazard ratio of 0.78, with continued separation of survival curves over time.
Safety outcomes were consistent with known profiles for IMFINZI and FLOT chemotherapy. Rates of Grade 3 or higher adverse events were comparable between treatment arms, and surgery completion rates were similar.
The application was reviewed under the FDA’s Project Orbis, enabling parallel consideration by regulators in Australia, Canada, and Switzerland. Additional reviews are underway in the European Union, Japan, and other markets.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.