Zolbetuximab with fluoropyrimidine- and platinum-based chemotherapy is not recommended, within its marketing authorisation, for untreated, locally advanced, unresectable or metastatic, claudin-18.2-positive, HER2-negative, gastric or gastro-oesophageal junction adenocarcinoma in adults.
This recommendation is not intended to affect treatment with zolbetuximab with fluoropyrimidine- and platinum-based chemotherapy 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 healthcare professional consider it appropriate to stop.
Why the committee made these recommendations
Usual treatment for gastric or gastro-oesophageal junction adenocarcinoma includes chemotherapy alone, or with nivolumab or pembrolizumab if the tumours express a protein called PD-L1. Zolbetuximab plus fluoropyrimidine- and platinum-based chemotherapy (from here, zolbetuximab plus chemotherapy) is a treatment option for cancer that makes a protein called claudin 18.2.
Clinical trial evidence shows that people who have zolbetuximab plus chemotherapy have longer before their cancer gets worse and live longer than people who have placebo plus chemotherapy. Zolbetuximab plus chemotherapy has not been directly compared with nivolumab plus chemotherapy or pembrolizumab plus chemotherapy. Results of an indirect comparison are uncertain but suggest that zolbetuximab may not work as well as either of these treatments in people who can have nivolumab or pembrolizumab.
Even when considering the condition's severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates for zolbetuximab plus chemotherapy compared with chemotherapy alone are above what NICE considers an acceptable use of NHS resources. The most likely cost-effectiveness estimates for zolbetuximab plus chemotherapy compared with nivolumab plus chemotherapy or pembrolizumab plus chemotherapy show that zolbetuximab was less costly, but may be less effective in people who can have nivolumab or pembrolizumab. So, zolbetuximab is not recommended.