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Recently, Zymeworks announced that its bispecific antibody Zanidatamab targeting HER2, combined with chemotherapy, has shown encouraging results in a phase 1 clinical trial for the treatment of refractory HER2-positive breast cancer patients who have received multiple pre-treatments.
Zanidatamab can simultaneously bind to two non-overlapping HER2 epitopes, which is called biparatopic binding
The results of the Zanidatamab clinical trial showed that the combination therapy achieved an objective response rate of 37.
Previously, the FDA has granted Zanidatamab a breakthrough therapy designation for use in previously treated HER2 gene amplified biliary tract cancer (BTC) patients, and has granted Zanidatamab two fast-track designations as a single-agent treatment for refractory BTC, and Combined with chemotherapy in the first-line treatment of gastroesophageal adenocarcinoma
In addition, Zanidatamab has been approved by the FDA as an orphan drug for the treatment of biliary tract cancer, gastric cancer and ovarian cancer, and has been approved by the European Medicines Agency as an orphan drug for the treatment of biliary tract cancer and gastric cancer