An Enhertu me-too is a winning formula for BioNTech

With an array of industry work ongoing trying to emulate Daiichi Sankyo/AstraZeneca's anti-HER2 ADC juggernaut Enhertu, one success story might not count for much. But Friday's apparent hit for DualityBio's trastuzumab pamirtecan in a phase 3 breast cancer study managed to send the shares of BioNTech, to which the asset is licensed, up 10%. That's equivalent to a market cap increase of about $2.5bn – not bad given that all that was disclosed was that the DualityBio-sponsored Dynasty-Breast01 study met a PFS endpoint at interim analysis. This concerned a Chinese population, and the comparator was Roche's Kadcyla. Still, perhaps the enthusiasm reflects the fact that this is trastu-p's first pivotal win; specifically, the study concerned Herceptin-pretreated HER2-positive patients, a setting in which Enhertu is approved based on the Destiny-Breast03 trial, where it beat Kadcyla on progression-free (0.28 hazard ratio) as well as on overall survival (0.64). DualityBio is separately running the Dynasty-Breast02 trial, which tests trastu-p in a HER2-low population, where Enhertu is approved on the back of Destiny-Breast04.