Hanmi Pharmaceuticals announced on September 27 that its partner, Spectrum, unveiled the latest interim results of the phase two clinical trial on "Poziotinib," the Korean drug company's lung cancer treatment, at the 19th World Conference on Lung Cancer (WCLC) held in Toronto, Canada on the 25th (local time).
This oral presentation included latest interim results of the phase two clinical trial on Poziotinib conducted at the MD Anderson Cancer Center, and it is the single largest clinical data conducted on patients with EGFR and HER2 Exon 20 mutations.
The company demonstrated 55 percent of partial response (PR) and an intermediate value of 5.1 months of progression free survival (PFS) on non-small cell lung cancer patients with EGFR Exon 20 mutations, for whom there is no treatment as of now.
In the case of the objective response rate (ORR), the existing treatment was less than 8% and the secondary treatment (Docitaxel-PD-1/PD-L1 repressor) was less than 19%, while Poziotinib exhibited 43%. Currently, 19 EGFR patients are receiving the treatment, and six of them have been taking P2O for over a year.
In non-small cell lung cancer patients with HER2 Exon 20 mutation, the drug was shown effective with a 50 % PR and an intermediate value of 5.1 months of PFS.
The most common toxic responses associated with EGFR were skin rashes, diarrhea, and nail infections. 60% of patients required a dose reduction, while only 3% of the total patients needed to have the treatment ceased, which was a minor degree of disruption.
Currently, patient registrations in global clinical trials for Poziotinib, including cohort studies on non-small cell lung cancer patients with EGFR Exon 20 mutations to check the plausibility of the first treatment and other solid cancer studies, are actively being done.
There are four major clinical programs for the Poziotinib clinical program: target treatment for non-small cell lung cancer patients who have received original treatment, first non-small cell lung cancer treatment, combination therapy with other drugs, and other solid cancer treatments.
Dr. John Heymack at the MD Anderson Cancer Center at the University of Texas (head and professor of thorax, head and neck oncology department) said, “We have verified effectiveness and safety of Poziotinib on non-small cell lung cancer patients with EGFR Exon 20 mutations, to whom there is no treatment out there yet. I believe that Poziotinib will prove a treatment option that patients with EGFR Exon 20 mutations need.”
Posotinek is an anti-cancer drug candidate that was co-developed by Hanmi Pharmaceuticals and National New Anticancer Drug Development Agency and was licensed out to Spectrum in 2012. Currently, the MD Anderson Cancer Center is carrying out phase two clinical trial, and the U.S. phase two trial is expected to expand to Canada and Europe in the future.