Effectiveness Approved
The result of a clinical study evaluating poziotinib, a MEK-targeted cancer treatment which was developed by Hanmi Pharmaceutical and licensed out by U.S.-based Spectrum Pharmaceuticals, was announced on October 18 at the World Conference on Lung Cancer (WCLC) held in Yokohama, Japan.
At the announcement, Dr. John Heymach, a professor at the University of Texas MD Anderson Cancer Center and one of the internationally known leaders in the field of clinical oncology, said, “Poziotinib showed superior efficacy in non-small-cell lung cancer patients with exon 20 mutation than existing EGFR tyrosine kinase inhibitors (TKIs). The study also confirmed the possibility that the drug could be actively effective on patients with cancerous cells spread to the central nervous system and leptomeningeal carcinomatosis.”
Currently, about 10 percent of non-small-cell lung cancer patients with EGFR mutation suffer from exon 20 mutation. However, no cure has been developed to treat the disease to date.
According to the announcement, Poziotinib showed more than 40 times stronger potency and 80 percent tumor shrinkage than TKIs on genetically engineered mouse (GEM) models and patient-derived xenograft (PDX) models. The MD Anderson Cancer Center is now conducting a phase-2 clinical trial on 60 lung cancer patients with exon 20 mutation. The study’s objective response rate (ORR) or partial response rate (PRR) marked 73 percent or eight out of 11 study patients so far.
“Patients who suffer from EGFR exon 20 mutation have a poor prognosis with response rates of a single digit and median progression-free survival (PFS) of less than two months on first-generation TKIs. However, it was remarkable that all 11 study patients who received poziotinib at a 16mg daily dose have seen tumor shrinkage, as well as evidence of activity in the central nervous system,” said Heymach.
Hanmi Pharmaceutical CEO Kwon Se-chang said, “The latest result of the clinical trial of poziotinib marked a milestone to open a new prospect in the field of intractable cancer treatment. We will make an every effort to commercialize it as soon as possible based on the result.”