South Korea’s Hanmi Pharmaceutical said Thursday that its global partner Spectrum Pharmaceuticals will be announcing the results of phase 2 clinical trials for poziotinib, a lung cancer treatment currently under development, at the IASLC 19th World Conference on Lung Cancer.

Spectrum Pharmaceuticals plans to present the results of phase 2 non-small cell lung cancer study using poziotinib, which includes, for the first time, data on the drug’s efficacy for patients with EGFR and HER2 exon 20 mutations.


Among the 40 out of 50 patients in the EGFR cohort with analysis-ready data, poziotinib showed a robust efficacy with an objective response rate of 58 percent. The median progression-free survival period was 5.6 months, while the disease control rate was 90 percent.

In the HER2 cohort, the objective response rate was 50 percent, while the disease control rate was 83 percent, according to Spectrum Pharmaceuticals.

The most common side effects were skin rash (27.5 percent), diarrhea (12.5 percent) and paronychia (7.5 percent). Around 45 percent of the patients involved in the study required a dose reduction to 12 milligrams, while 17.5 percent required a dose reduction to 8 mg.

Spectrum Pharmaceuticals said it plans to share updated data on the study during an oral presentation at the lung cancer academic conference in Toronto, Canada, on Sept. 24.

“We expect poziotinib to present a new treatment paradigm to patients which haven’t been responding to existing treatments. We will work hard to commercialize the drug to bring hope to patients suffering from cancer,” said Hanmi Pharmaceutical CEO Kwon Se-chang in a statement.

Looking ahead, Spectrum Pharmaceuticals said it is working to expand the poziotinib clinical program to explore the drug’s efficacy in a number of new areas, including first-line treatment of NSCLC, treatment of other solid tumors with EGFR or HER2 mutations, as well as other combination therapies.

By Sohn Ji-young (jys@heraldcorp.com)