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Jazz sets zani sights on a post-Enhertu world

You can’t accuse Jazz Pharmaceuticals of ignoring the way Daiichi Sankyo/AstraZeneca’s Enhertu is reshaping breast cancer treatment. Empowher-BC-303, Jazz’s latest phase 3 study of zanidatamab, will see this biparatopic anti-HER2 MAb tested in HER2-positive breast cancer patients who have had disease progression after Enhertu, according to a recently unveiled listing. This is an acceptance of the reality that many ER-positive patients, including those with low – and, perhaps soon, ultralow – expression of HER2 will see Enhertu early on in their disease. Jazz is betting that zani’s ability to hit two separate HER2 epitopes will allow it to work once Enhertu no longer does. Jazz licensed zani’s western development and commercialisation rights from Zymeworks in October 2022 for $50m up front, four years after Asia rights, including Zymeworks’ anti-HER2 ADC zanidatamab zovodotin, were picked up by BeiGene for $40m. In May the FDA accepted zani’s first US filing, for previously treated HER2-positive biliary tract cancer, setting a 29 November PDUFA date. The confirmatory Herizon-BTC-302 trial is under way, and including this Empowher-BC-303 is zani’s third phase 3 study; Empowher-BC-303 first appeared on OncologyPipeline in March, when Jazz outlined its pivotal breast cancer plans.


Phase 3 studies of zanidatamab

Herizon-BTC-3021L biliary tract cancer (confirmatory trial)Chemo combo +/- Keytruda/Imfinzi, vs chemo +/- Keytruda/Imfinzi
Herizon-GEA-011L HER2+ve gastroesophageal adenocarcinomaChemo combo +/- Tevimbra, vs Herceptin + chemo
Empowher-BC-303≤5L (incl Enhertu) HER2+ve breast cancerChemo combo, vs Hereceptin + chemo

Source: OncologyPipeline.