NICE Approves AstraZeneca’s Durvalumab for Aggressive Stomach Cancer

More than 1,500 people in England with resectable gastric or gastro-oesophageal junction adenocarcinoma are set to gain access to the first immunotherapy recommended on the NHS for operable stomach cancer, following a recommendation from the UK’s National Institute for Health and Care Excellence (NICE).

The treatment, durvalumab, marketed as Imfinzi by AstraZeneca, is recommended for adults whose cancer can be removed surgically. It will be used with perioperative FLOT chemotherapy fluorouracil, leucovorin, oxaliplatin, and docetaxel before and after surgery, followed by durvalumab monotherapy after surgery.

Durvalumab received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) 17 days before NICE issued its recommendation. NICE said it used a streamlined “light-touch” assessment process to accelerate patient access without requiring a formal committee meeting.

Gastric and gastro-oesophageal junction cancers arise in the stomach or where the stomach meets the oesophagus. The disease is frequently diagnosed at an advanced stage, recurrence after surgery remains common, and only around half of patients survive five years after diagnosis.

The recommendation is supported by findings from the phase 3 MATTERHORN trial (NCT04592913), which enrolled 948 patients with previously untreated, resectable stage II to IVA gastric or gastro-oesophageal junction adenocarcinoma. Adding durvalumab to perioperative FLOT significantly improved event-free survival compared with chemotherapy alone. Median event-free survival was not reached in the durvalumab arm versus 32.8 months in the placebo arm, corresponding to a hazard ratio of 0.71.

Overall survival findings also favoured durvalumab. At three years, 68.6% of patients receiving durvalumab were alive compared with 61.9% in the chemotherapy-alone arm. The reported overall survival hazard ratio was 0.78, although median overall survival had not yet been reached in either group.

Durvalumab is administered as an intravenous infusion every four weeks. The PD-L1 inhibitor blocks protein cancer cells use to evade immune detection, helping the immune system identify and attack tumour cells.

Safety findings indicated that adding durvalumab did not meaningfully increase severe toxicity. Grade 3 or 4 adverse events occurred in 71.6% of patients receiving durvalumab and 71.2% of those receiving placebo, while delayed surgery occurred in 10.1% and 10.8% of patients, respectively.

Patient groups and clinical experts told NICE that recurrence after surgery remains a major challenge in stomach cancer treatment, underlining the need for therapies that can extend survival and reduce relapse risk.

Helen Knight, director of medicines evaluation at National Institute for Health and Care Excellence, said the recommendation addresses a significant unmet need and reflects NICE’s efforts to provide faster NHS access to promising therapies while maintaining value for money.

Sheena Dewan, executive director of Stomach Cancer UK, described the approval as the first major advance in curative-intent treatment for stomach cancer in nearly a decade. She said adding immunotherapy to perioperative chemotherapy could help reduce recurrence and improve long-term survival for patients undergoing surgery.

NICE confirmed that AstraZeneca has agreed to provide durvalumab to the NHS through a confidential commercial arrangement that includes a discount.

Reference

Over 1,500 people set to benefit from first immunotherapy for aggressive stomach cancer | NICE

Study Details | NCT04592913 | Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer | ClinicalTrials.gov