A potentially $1.76 billion oncology deal created a little more than three years ago between partners Jazz Pharmaceuticals plc and Zymeworks Inc. now has a more solid direction. New and positive top-line results for the phase III Herizon-GEA-01 study of the HER2-targeted bispecific antibody zanidatamab in locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) moved the stock and expectations for both companies.
A paper last month in the Journal of Clinical Oncology reported on the pooled analysis of data showing that the use of neoadjuvant immune checkpoint inhibitors work better than the frequently used FLOT regimen (fluorouracil, leucovorin, oxaliplatin and docetaxel) in certain gastroesophageal adenocarcinoma (GEA) cancers. But there’s plenty more coming down the pike, even as scientific knowledge about the disease advances.
More than a week ahead of its priority PDUFA date, the U.S. FDA has greenlit the first dual HER2-targeted bispecific antibody specifically for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The approval went to Jazz Pharmaceuticals plc for Ziihera (zanidatamab), an injection given to adults every two weeks. The treatment was designed to have a more favorable profile than competitors, where drugs targeting HER2 such as Astrazeneca plc’s Enhertu (trastuzumab deruxtecan) and Roche Holding AG’s Herceptin (trastuzumab) are options, as well as checkpoint inhibitors such as Merck & Co Inc.’s Keytruda (pembrolizumab).