AstraZeneca’s Imfinzi (durvalumab) has been granted priority review by the US Food and Drug Administration (FDA) to treat early-stage gastric cancer.
The decision specifically applies to patients with resectable, early-stage and locally advanced (stages 2, 3 and 4a) gastric and gastroesophageal junction (GEJ) cancers.
The immunotherapy, which was also recently granted breakthrough therapy designation by the US regulator in this setting, will now benefit from an expedited review process.
AZ’s application is based on results from the late-stage MATTERHORN trial, which has been evaluating Imfinzi in combination with standard-of-care fluorouracil, leucovorin, oxaliplatin and docetaxel chemotherapy prior to surgery, followed by Imfinzi plus chemotherapy after surgery, then Imfinzi monotherapy.
In the study, the Imfinzi-based regimen was associated with a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone, while estimated median event-free survival (EFS) was not yet reached for the Imfinzi arm versus 32.8 months for the comparator arm.
Gastric cancer is the fifth leading cause of cancer-related deaths globally, with almost one million cases of the disease diagnosed globally in 2022.
Despite undergoing surgery with curative intent and treatment with neoadjuvant/adjuvant chemotherapy, around one in four patients with resectable gastric cancer develop recurrent disease within one year, and one in four do not survive beyond two years.
Imfinzi is designed to target the PD-L1 protein, which cancer cells use to evade the immune system, and is already approved in the US to treat certain cases of lung cancer, biliary tract cancer, bladder cancer, endometrial cancer and hepatocellular carcinoma.
Commenting on the latest decision on the drug, Susan Galbraith, executive vice president, oncology haematology research and development, AZ, said: “This priority review reinforces the potential for a perioperative approach with Imfinzi to transform care for patients with early gastric and GEJ cancers, who frequently face disease recurrence or progression even after curative-intent surgery and perioperative chemotherapy.
“This novel treatment is the only immunotherapy-based regimen to show a statistically significant reduction in the risk of progression, recurrence or death in this setting, and if approved, is poised to change the clinical paradigm.”