Hanmi Pharmaceutical said that Spectrum, its U.S. partner, submitted a new drug application (NDA) for poziotinib, a non-small cell lung cancer (NSCLC) treatment, to the U.S. Food and Drug Administration on Monday.

Hanmi explained that Spectrum submitted the NDA based on positive cohort 2 results of the ZENITH20 clinical trial evaluating the safety and efficacy of poziotinib in HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) patients with past treatment experience. To date, no treatment has received approval from the FDA for this indication.

Before submitting the NDA, Spectrum had also conducted a pre-NDA meeting with the FDA and confirmed that cohort 2 could be the basis for an NDA submission. Cohort 2 is a clinical trial that administered 16mg of poziotinib once a day to 90 patients with NSCLC.

The results showed that the objective response rate (ORR) was 27.8 percent, reaching the minimum valid value (17 percent).

Also, the median duration of response (mDOR) was 5.1 months, with the follow-up period being 8.3 months, and the median progression-free survival was 5.5 months.

Spectrum stressed that it would continue to work closely with FDA while FDA conducts a marketing authorization review.

"We have reached an important step toward achieving the first treatment for patients with HER2 Exon 20 insertion mutation lung cancer," Spectrum CEO Joe Turgeon said. "We would like to thank the researchers, patients, and Spectrum staff for their passionate efforts to achieve this important milestone in an area with high unmet medical need."

Poziotinib is an innovative new lung cancer drug Hanmi developed and licensed out to Spectrum in 2019 and received fast-track designation from the FDA in March.