1 Recommendations
1.1 Nivolumab with platinum- and fluoropyrimidine-based chemotherapy is recommended, within its 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. Nivolumab is only recommended if the company provides it according to the commercial arrangement.
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 plus 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 plus XELOX or FOLFOX compared with XELOX or FOLFOX alone. But, it is uncertain how long people lived beyond the trial period and for how long nivolumab's benefit lasted.
People with these conditions on average have a short life expectancy, so nivolumab meets NICE's criteria to be considered a life-extending treatment at the end of life. The cost-effectiveness estimates for nivolumab are within what NICE considers an acceptable use of NHS resources. So, nivolumab with platinum- and fluoropyrimidine-based chemotherapy is recommended.