The evaluation of poziotinib in the ZENITH20 Phase 2 clinical trial has accomplished the pre-specified primary endpoint. According to Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI), which was a co-developer of the agent. This had been used previously to treat patients suffering from non-small cell lung cancer (NSCLC) as well as HER2 exon 20 insertion mutations.
The company’s CEO, Joe Turgeon, says that this is just the beginning of many milestones they seek to accomplish and will give them significant advancement. The study enrolled ninety patients who received a daily dose of oral poziotinib at 16 mg, and from all of them, there were confirmed objective response rates (ORR).
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Poziotinib inhibits HER2 and HER4, and the tyrosine kinase activity of EGFR, all this results in the inhibition of the proliferation of tumor cells. Spectrum has the full rights of development, manufacturing, and commercializing it across the globe. However, commercialization is not allowed in Korea and China.
Lack of Approved Therapies for HER2 exon 20 Insertion Mutations in NSCLC
Spectrum has a proven and very strong track record in the development of novel therapies. Its zeal is in the identification and delivery of treatment options to patients who have cancer. To accomplish this, the company has been exploring and assessing multiple preclinical and clinical data.
The saddest part is the market does not have approved therapies for HER2 exon 20 insertion mutations. As a result, hundreds of patients have turned to options, which are seemingly not working. This is the more reason why the company is pursuing a meeting with the FDA to discuss the positive results from poziotinib. Once the data is approved, the agent will become a potential treatment for the deadly disease. This will lead to a New Drug Application (NDA) submission.
Bringing Quality Drugs to Patients
Spectrum’s primary goal is to bring the most promising products to the market through the least complex development process. Now and then, the company engages development experts who share in its dreams and passion for building value for its customers. Its corporate culture is that of compliance, integrity, and respecting all the processes.