Spectrum, Hanmi Pharmaceutical’s U.S. partner, said Tuesday that it presented an online abstract of a new interim phase 2 clinical trial for Poziotinib, a non-small cell lung cancer treatment. The trial is underway at the MD Anderson Cancer Center in the U.S.
The company plans to present the full data at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer on Sep. 24.
The abstract included interim results from a cohort study of patients with non-small cell lung cancer who have epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor type2 (HER-2) exon20 mutations. The report is also the first study to produce results for the HER2 cohort study.
The EGFR cohort study included response rates of 40 out of 50 patients enrolled in the trial. The data showed that Poziotinib continued to show robust efficacy with an objective response rate (ORR) of 58 percent. The study also showed a disease control rate (DCR) of 90 percent and a median progression-free survival (Median PFS) of 5.6 months.
Regarding the HER2 cohort, the company found an ORR of 50 percent and DCR of 83 percent.
The most common side effects were skin rash, diarrhea, and nail inflammation, which are common EGFR drug-related side effects. To control adverse effects, some patients reduced their doses by 12 mg or 8 mg.
“This study is important evidence in supporting the role of Poziotinib in the treatment of patients with EGFR and HER2 exon20 mutations, and will lead to significant advances for patients who have not had any targeted therapies,” said John Heymach, professor and chair of thoracic/head and neck medical oncology department at MD Anderson Cancer Center. “The results are the largest single data from patients with high unmet needs.”
In response to Spectrum’s interim result, Hanmi released a statement expressing its expectation, on Tuesday.
“Poziotinib is expected to provide a new therapeutic paradigm for patients who have not had a major effect with traditional therapies,” Hanmi CEO Kwon Se-chang said. “We will do our best to commercialize the treatment so that we can give hope to cancer patients.”