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On August 25, the U.S. Food and Drug Administration approved the bispecific antibody Ziihera (zanidatamab) for use in two different combination treatments for the first-line treatment of advanced HER2-positive gastric cancer that cannot be removed with surgery. One combines the Ziihera with chemotherapy and the second adds those two drugs to the immunotherapy drug Tevimbra (tislelizumab).
HER2 is a protein on cancer cells that drives tumor growth. Ziihera, which is being developed by Gastric Cancer Foundation sponsors Jazz Pharmaceuticals and BeOne Medicines, is a bispecific antibody that works by inhibiting HER2 from two separate angles. Tevimbra frees up the immune system to further attack the cancer by inhibiting the protein PD-1. The combination of Ziihera, Tevimbra and chemotherapy was approved for all HER2-positive patients regardless of whether or not their tumors express high levels of PD-1.
The approvals were based on results from a pivotal trial, which demonstrated that both drug combinations reduced the risk of tumor progression or death by 35% in HER2-positive gastric cancer patients. Significantly, the combination of Ziihera, Tevimbra and chemotherapy extended median overall survival by seven months when compared to Herceptin (trastuzumab) plus chemotherapy. The median overall survival of 26.4 months among patients on the newly approved drug regimen was the longest ever reported in a phase 3 trial in HER2-positive gastric cancer patients.
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