Arcus plans to launch the global, registrational Phase III study PRISM-1 in 2024, which will assess quemliclustat plus chemotherapy against chemotherapy alone in previously untreated mPDAC patients.
The decision to progress to Phase III trials stems from promising overall survival results from the Phase Ib ARC-8 study.
With this licensing agreement, Taiho will support the development and potential commercialisation of quemliclustat and will also manage the operational aspects of the PRISM-1 study in Japan.
Taiho has already secured exclusive development and commercialisation rights for four Arcus programmes in Japan and Asian regions excluding mainland China.
Gilead Sciences holds the rights to commercialise quemliclustat in the US and co-promote with Arcus, as well as exclusive rights to develop and commercialise the product outside the US.