Biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (NYSE: AZN) reported on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Imfinzi (durvalumab) in combination with FLOT chemotherapy as a perioperative treatment for adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers.

Positive opinion was based on Phase III MATTERHORN trial data demonstrating statistically significant improvements in event-free survival and overall survival versus chemotherapy alone. Trial results showed a 29% reduction in the risk of disease progression, recurrence or death and a 22% reduction in the risk of death for the Imfinzi-based regimen. Benefits were observed regardless of PD-L1 status.

If approved, Imfinzi would become the first immunotherapy-based perioperative treatment for this patient population in the European Union. Regimen consists of Imfinzi plus chemotherapy before surgery, followed by Imfinzi plus chemotherapy after surgery and subsequent Imfinzi monotherapy.

The safety profile of Imfinzi combined with FLOT chemotherapy was consistent with known profiles, with similar rates of grade 3 or higher adverse events compared with chemotherapy alone and comparable surgery completion rates.

Imfinzi is already approved in the US and other markets for this indication based on MATTERHORN results, with regulatory reviews ongoing in Japan and additional countries. Gastric cancer remains a major global health burden, with nearly one million diagnoses annually and high recurrence rates despite curative-intent surgery.

AstraZeneca is focused on oncology, rare diseases and bio-pharmaceuticals, with Imfinzi positioned as a core immuno-oncology asset across multiple tumour types and stages.