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The National Institute for Health and Care Excellence (NICE) has recommended durvalumab (Imfinzi, AstraZeneca) as the first immunotherapy option for adults with resectable gastric or gastro-oesophageal junction adenocarcinoma. 

Under NICE’s final draft guidance, the drug is indicated for use alongside fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy before and after surgery, followed by durvalumab monotherapy as adjuvant treatment. NICE said the treatment must be funded by the NHS in England within 90 days of final publication of the guidance if it is considered the most suitable option for an eligible patient. 

More than 1500 patients a year are set to benefit from the new therapy.

Disease Background and Drug Mechanism

Gastric and gastro-oesophageal junction cancer, where tumours develop in the stomach or at the junction with the oesophagus, is often diagnosed at an advanced stage. Even when surgery is feasible, the cancer recurs in many patients, with only around half of people surviving 5 years after diagnosis.

Usual perioperative treatment for resectable gastric or gastro-oesophageal junction adenocarcinoma is FLOT chemotherapy. NICE’s final draft guidance adds durvalumab to this perioperative chemotherapy approach, followed by durvalumab alone after surgery. 

Durvalumab is an immune checkpoint inhibitor that blocks PD-L1 protein, which can help cancer cells evade immune detection. By inhibiting PD-L1, durvalumab enhances antitumour immune activity. The drug is delivered via intravenous infusion every 4 weeks.

Clinical Evidence

Clinical trial evidence showed that adding durvalumab to perioperative FLOT, followed by durvalumab monotherapy, increased how long patients lived before their cancer worsened and improved overall survival compared with chemotherapy alone. 

In the phase 3 MATTERHORN trial, durvalumab plus FLOT significantly improved event-free survival vs placebo plus FLOT, reducing the risk for disease progression, recurrence, or death by 29%. Median event-free survival was not reached in the durvalumab arm and was 32.8 months in the control arm.

Final overall survival data released by AstraZeneca showed a 22% reduction in the risk for death, with 68.6% of patients receiving the durvalumab-based regimen alive at 3 years compared with 61.9% receiving chemotherapy alone.

NICE concluded that despite some uncertainty in the clinical-effectiveness evidence and economic model, the most likely cost-effectiveness estimates were within the range considered an acceptable use of NHS resources.

Treatment Access

NICE applied its streamlined assessment process to evaluate durvalumab, enabling faster access without requiring a committee meeting. The drug received its marketing authorisation from the Medicines and Healthcare products Regulatory Agency 17 days before NICE issued the guidance. 

AstraZeneca has established a confidential commercial arrangement that provides durvalumab to the NHS with a discount. The list price is £592.00 per 2.4-mL vial and £2466.00 per 10-mL vial, excluding VAT. The size of the NHS discount is commercial in confidence.

For clinicians, the recommendation is most relevant to multidisciplinary teams managing patients with resectable gastric or gastro-oesophageal junction adenocarcinoma who are candidates for perioperative FLOT and surgery. NICE said durvalumab should be available when the treating healthcare professional considers it the right option, in line with the guidance.

Helen Knight, director of medicines evaluation at NICE, said: “Being able to recommend this drug faster through our streamlined process will benefit thousands of people with this aggressive form of cancer.”