Release Date: 15-Jul-2024
Targeting certain molecular markers has become an important method in cancer therapies, and one such marker that has received a lot of interest is the human epidermal growth factor receptor 2 (HER2). Overexpression of HER2 has been linked to a variety of malignancies, making it an important target for novel therapeutic approaches. As a HER2xHER2-directed bispecific antibody, Zanidatamab marks a milestone in the field. Zanidatamab is being developed by Zymeworks in partnership with BeiGene and Jazz Pharmaceuticals, using its patented Azymetric platform.
This novel drug can bind two non-overlapping HER2 epitopes at the same time, increasing selectivity and perhaps circumventing resistance mechanisms identified with single-agent therapy. Zanidatamab’s bispecificity allows it to more effectively engage HER2-expressing cells, eliciting a strong immune response against the tumor. Zanidatamab is at various stages of clinical studies for various HER2-expressing solid tumors, both as monotherapy and in combination with other anticancer medicines.
The results of an ongoing phase 2a trial, which showed that zanidatamab in combination with palbociclib and fulvestrant showed significant progression-free survival outcomes along with a well-tolerated safety profile in patients with heavily pretreated HER2+/HR+ metastatic breast cancer, were presented at the San Antonio Breast Cancer Symposium in December 2023. Similarly, in June 2023, at the ASCO Annual Meeting, another set of results from the ongoing phase IIb HERIZON-BTC-01 clinical trial evaluating Zanidatamab in treatment-refractory HER2-positive biliary tract cancer were announced, in which zanidatamab demonstrated meaningful activity, including rapid and durable responses, with a favorable safety profile.
Zanidatamab’s promise has been recognized by regulatory agencies all around the world, as indicated by the multiple designations the drug has received. The US Food FDA has granted zanidatamab Breakthrough Therapy designation in patients with previously treated HER2 gene-amplified biliary tract cancers (BTC), as well as two Fast Track designations - one as a monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line GEA. In April 2024, Jazz Pharmaceuticals announced the submission of a Biologics License Application (BLA) to the FDA) seeking accelerated approval for Zanidatamab for the treatment HER2-positive BTC.
Zanidatamab appears to have a promising future in light of the favorable clinical trial results and recognition from several regulatory organizations. Furthermore, as one of the only bispecific antibodies in late-stage clinical trials for solid tumors, Zanidatamab has the potential to modify therapy regimens for multiple HER2-positive cancers, giving patients hope as a promising emerging candidate.
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