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Nivolumab with platinum- and fluoropyrimidine-based chemotherapy for untreated HER2-negative advanced gastric, gastro-oesophageal junction or oesophageal adenocarcinoma

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1 Recommendations

1.1 Nivolumab with platinum- and fluoropyrimidine-based combination chemotherapy is not recommended, within its anticipated marketing authorisation, as an option for untreated HER2-negative, advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma in adults whose tumours express PD-L1 with a combined positive score (CPS) of 5 or more.

1.2 This recommendation is not intended to affect treatment with nivolumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

There are no curative treatment options for HER2-negative, advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma that expresses PD-L1 with a CPS of 5 or more. The usual treatment is palliative chemotherapy. Most people have platinum- and fluoropyrimidine-based chemotherapy with capecitabine plus oxaliplatin (XELOX) or fluorouracil plus oxaliplatin with folinic acid (FOLFOX).

Clinical trial evidence shows that nivolumab with XELOX or FOLFOX increases the length of time before gastric, gastro-oesophageal junction or oesophageal adenocarcinoma gets worse compared with XELOX or FOLFOX alone. Evidence also shows that people live longer if they have nivolumab with XELOX or FELOX compared with XELOX or FOLFOX alone.

Nivolumab meets NICE's criteria to be considered a life-extending treatment at the end of life. But, the company's economic model is not suitable for decision making because it includes assumptions which overestimate how long people live after treatment and its survival estimates are not supported by clinical trial evidence. Also, the model is not suitable for exploring how different assumptions about people's long-term survival affect the cost-effectiveness estimates. This means that it is not possible to determine whether nivolumab is cost effective. So, nivolumab is not recommended.