Bristol's third pivotal iza-bren study

Shortly after taking the SystImmune-originated anti-HER3 x EGFR antibody-drug conjugate izalontamab brengitecan into pivotal development in lung cancer, Bristol Myers Squibb is to start a phase 2/3 trial in urothelial bladder carcinoma. The Izabright-Bladder01 study, just revealed on the clinicaltrials.gov registry, is to begin in October, and like Bristol's other pivotal efforts will test iza-bren monotherapy versus chemo. The Izabright-Lung01 trial is fundamentally identical to a corresponding Chinese trial sponsored by SystImmune, and Izabright-Bladder01 is pretty similar to a phase 3 trial SyntImmune began in March; both bladder cancer tests mandate prior failure on PD-(L)1 therapy, as well as on another systemic therapy in combination or in sequence for the former, and platinum chemo for the latter. This differs from the third pivotal trial Bristol has undertaken with iza-bren, in first-line triple-negative breast cancer; the corresponding Chinese pivotal test concerns a second-line setting. Bristol licensed iza-bren from SystImmune for $800m up front in December 2023, and a further $500m in milestones was due on the start of Bristol's pivotal breast and lung cancer trials. It doesn't appear that starting Izabright-Bladder01 triggers another milestone.

Selected pivotal studies of izalontamab brengitecan

Source: OncologyPipeline.