FDA has approved the combination regimen of durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin oxaliplatin, and docetaxel (FLOT) chemotherapy as a treatment for patients with early gastric and gastroesophageal cancers (1).
The approval follows FDA’s Priority Review of the regimen, which comprises neoadjuvant durvalumab in combination with chemotherapy before surgery, followed by adjuvant durvalumab in combination with chemotherapy, and then durvalumab as monotherapy.
The regulator’s decision will provide a new clinical option for patients with early gastric and gastroesophageal cancers that can deliver a significant survival benefit versus chemotherapy alone.
Durvalumab is a human monoclonal antibody that works by binding to the PD-L1 protein and blocking the interaction of PD-L1 with the PD-1 and CD80 proteins, which counteracts the tumour’s immune-evading tactics and releasing the inhibition of immune responses.
The regulator’s decision has been based on the positive results of the Matterhorn Phase III trial aimed at evaluating durvalumab as perioperative treatment for patients with resectable Stage II-IVA gastric and gastroesophageal junction (GEJ) cancers. The randomized, double-blind, placebo-controlled, multi-centre, global Phase III trial demonstrated a 29% reduction in the risk of progression, recurrence, or death, and a 22% reduction in the risk of death for the treatment regimen versus chemotherapy alone (1).
Safety of the combination regimen was found to be consistent with the known profiles of each separate medicine and the proportion of patients who completed surgery was similar compared with the chemotherapy alone arm. Incidence of grade three or higher adverse events was similar between the two arms of the trial.
The combination regimen is also under regulatory consideration in Australia, Canada, and Switzerland for the same indication as the US. Other regulatory applications are under review in the European Union, Japan, and several other countries.
Reference
- AstraZeneca. Imfinzi Approved in the US as First and Only Perioperative Immunotherapy for Patients with Early Gastric and Gastroesophageal Cancers. Press Release, Nov. 21, 2025.
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