Astellas gives the Claudin18.2 pipeline a boost

Astellas’s zolbetuximab is the lead project against a popular target, Claudin18.2, so its apparent late-stage success today should bring cheer to the Japanese company and beyond. There is a host of other groups attempting to hit Claudin18.2, which is thought to be overexpressed on gastric and pancreatic cancers in particular. However, most players are at an early stage, and there has so far not been much big pharma involvement. The question now is whether this might change after the success of Astellas’s phase 3 Spotlight trial, which compared zolbetuximab plus mFolfox6 chemo against placebo plus mFolfox6 in first-line Claudin18.2-positive gastric cancers. All Astellas is saying is that the study hit both its primary endpoint of progression-free survival and a key secondary, overall survival. As always, the devil will be in the detail, and it is notable that in phase 2 zolbetuximab’s benefit was driven by patients with the highest Claudin18.2 levels, defined as expression of 70% or more. Zolbetuximab is Astellas’s most valuable R&D asset, with forecast 2028 sales of $522m, according to Evaluate Pharma sellside consensus. Data are also expected by year end from a second pivotal gastric cancer study, using a different chemo backbone.

Mid to late-stage Claudin18.2-targeting projects
Project Company Description Status
Phase 3
Zolbetuximab Astellas Pharma Anti-Claudin18.2 MAb Hit PFS & OS in ph3 Spotlight + mFolfox6; Glow + Capox to readout Q4 2022; both in Claudin18.2+ve gastric/GEJ adenocarcinoma
Phase 2
TST001 Transcenta Holding Anti-Claudin18.2 MAb NCT05190575* in Claudin18.2+ve biliary tract cancer; ph1 in solid tumours in USChina 
CT041 Carsgen Therapeutics Anti-Claudin18.2 Car-T NCT04404595 in Claudin18.2+ve gastric & pancreatic cancers
*Investigator-sponsored trial; GEJ=gastroesophageal junction; Source: Evaluate Pharma &

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