The French firm’s Onivyde has missed the mark in an advanced small-cell lung cancer Phase III trial, prompting the firm to tout the drug’s prospects in a large pancreatic cancer indication instead.

Following rapid R&D growth in the area, China now has roughly 40 drug candidates targeting Claudin 18.2 across various modalities including monoclonal antibodies, antibody-drug conjugates and bispecific antibodies, with a number of contenders now striking international licensing-out deals in a bid to get ahead of rivals.

Company seeks accelerated approval based on changes in neurofilament as a surrogate for efficacy; with controversy over FDA’s Aduhelm approval in Alzheimer’s still raging, agency is again faced with deciding whether biomarker data in a neurodegenerative disease with high unmet need are sufficient to justify approval in the face of a failed clinical endpoint study.

FDA accepted the NDA for tofersen based on a surrogate biomarker after a Phase III trial failure, echoing some elements of the Aduhelm experience, though in this instance the target patient population is ultra-niche.