AstraZeneca’s Imfinzi (durvalumab) has been recommended by NICE for use in combination with perioperative chemotherapy for adults with resectable gastric or gastro-oesophageal junction adenocarcinoma, following recent approval from MHRA.

The recommendation makes Imfinzi the first immunotherapy approved in the UK for use alongside perioperative FLOT chemotherapy in this setting, offering a new treatment option for patients with operable gastric and gastro-oesophageal cancers.

The decision follows MHRA approval granted on 27 April and reflects closer alignment between UK regulatory and reimbursement pathways, supporting faster access to innovative medicines for eligible patients.

Gastric cancer remains the fifth leading cause of cancer-related death worldwide, accounting for approximately 660,000 deaths each year. In the UK, fewer than half of patients survive beyond five years after diagnosis, with an overall five-year survival rate of just 18%.

For patients diagnosed with resectable disease, surgery combined with chemotherapy can offer the possibility of cure, but recurrence rates remain high, highlighting the need for more effective early treatment strategies.

Tom Keith-Roach, country president of AstraZeneca UK, said: “The NICE recommendation coming shortly after MHRA approval means eligible patients with resectable gastric cancer may be able to access this treatment sooner.

“With outcomes still poor and high rates of recurrence despite surgery and chemotherapy, this is a meaningful step forward.”

The recommendation is based on results from the Phase 3 Matterhorn trial, which evaluated perioperative durvalumab in combination with FLOT chemotherapy in 948 patients with resectable, early-stage and locally advanced Stage II to IVA gastric and gastro-oesophageal junction adenocarcinoma.

Patients receiving durvalumab plus chemotherapy achieved the trial’s primary endpoint of improved event-free survival, with a 29% reduction in the risk of disease progression, recurrence or death compared with chemotherapy alone.

At 24 months, estimated event-free survival was 67% in the durvalumab group compared with 59% in the placebo group.

The study also showed an increase in pathological complete response rates, with 19% of patients receiving durvalumab achieving complete response compared with 7% in the control arm.

Sheena Dewan, executive director at Stomach Cancer UK, said: “The approval of durvalumab plus FLOT is a significant change in the treatment landscape for operable stomach cancer.

“For patients undergoing surgery and chemotherapy with the hope of a cure, reducing the risk of recurrence is everything.”

Wasat Mansoor, consultant in medical oncology at The Christie NHS Foundation Trust, added: “The Matterhorn results are particularly meaningful, showing that a durvalumab-based perioperative regimen improved patient outcomes.”

The safety profile of durvalumab plus FLOT was consistent with the known profiles of the individual medicines, with no new safety signals identified. The most common adverse events included diarrhoea, nausea, neutropenia, alopecia, fatigue and anaemia.

The NICE recommendation marks another expansion for Imfinzi, which is already approved across multiple cancer indications, and may help improve outcomes for patients with one of the most difficult-to-treat gastrointestinal cancers.