NICE Approves Durvalumab for Gastric Cancer Treatment

NICE has issued final draft guidance recommending durvalumab, within its marketing authorisation, for use with 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by durvalumab monotherapy as adjuvant treatment, in adults with resectable gastric or gastro-oesophageal junction adenocarcinoma. This recommendation rests on clinical trial evidence demonstrating that the regimen extends progression-free survival and overall survival relative to placebo plus FLOT chemotherapy followed by placebo alone. The most plausible cost-effectiveness estimates fall within the range NICE deems an acceptable use of NHS resources, enabling routine commissioning subject to the company’s confidential commercial access agreement.

Survival Gains Confirmed

Clinical trial data establish that adding durvalumab gastric cancer treatment to FLOT chemotherapy in both the neoadjuvant and adjuvant phases, then continuing durvalumab alone, produces measurable gains in the interval before disease progression and in duration of life compared with the placebo-controlled regimen. Although uncertainties persist in the clinical-effectiveness evidence and the associated economic model, the resulting incremental cost-effectiveness ratios remain acceptable under NICE criteria once the confidential discount is applied. This balance of demonstrated benefit and value for money underpins the decision to mandate NHS funding in England within 90 days of final guidance publication, ensuring consistent availability for eligible patients.

Evidence Review Completed

Usual care for resectable gastric or gastro-oesophageal junction adenocarcinoma consists of FLOT chemotherapy administered before and after surgery. The appraisal drew on randomised evidence comparing durvalumab plus FLOT against placebo plus FLOT in the perioperative setting, followed by maintenance therapy with the respective agents. The evaluation committee, operating under a streamlined process, reviewed the submitted clinical and economic data, acknowledged residual uncertainties, and concluded that the most likely estimates supported routine use. All supporting materials are contained in the committee papers, consistent with NICE’s technology appraisal procedures.

Access Pathway Secured

The recommendation expands access to perioperative immunotherapy for approximately 1,500 patients annually, requiring integrated care boards and NHS England to incorporate the regimen into routine commissioning budgets once interim Cancer Drugs Fund support concludes. Health Economics and Outcomes Research (HEOR) analyses will need to monitor real-world progression-free and overall survival outcomes alongside resource utilisation to confirm modelled assumptions. Market-access and pricing negotiations may increasingly reference similar confidential commercial arrangements to maintain cost-effectiveness thresholds, while health-technology-assessment bodies in other jurisdictions could draw on this precedent when evaluating comparable immuno-oncology combinations in gastrointestinal cancers.