Hanmi Pharmaceutical said that Spectrum, its U.S. partner, will apply for new drug approval (NDA) for poziotinib, a non-small cell lung cancer (NSCLC) treatment, in the U.S. next year.

Spectrum, Hanmi's U.S. partner, plans to apply for poziotinib’s NDA in the U.S. next year. (Hanmi)
Spectrum, Hanmi's U.S. partner, plans to apply for poziotinib’s NDA in the U.S. next year. (Hanmi)

"Spectrum said the U.S. Food and Drug Administration allowed Spectrum to submit an NDA request to a preliminary meeting based on the clinical results of its Cohort 2 clinical trial into HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) patients with past treatment experience," Hanmi said. "As such, Spectrum plans to apply for an NDA next year."

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.

"The agreement with the FDA to proceed with the submission of a new drug application is a significant milestone for the poziotinib program," Spectrum CEO Joe Turgeon said. "The improved tolerability from the BID dosing could have a meaningful impact on the overall safety and efficacy profile of poziotinib in an area of high unmet medical need."

The company also unveiled the results of its Cohort 3 and 5 clinical trials.

Cohort 3 is a clinical trial evaluating the efficacy of poziotinib as a first-line treatment for epidermal growth factor receptor (EGFR) Exon20 mutant-positive NSCLC patients without treatment experience. Through the trial, the company confirmed partial response in 22 patients (27.8 percent) after administering a 16mg dose to 79 patients once a day.

However, it failed to reach the trial's primary endpoint, which was the ORR's minimum effective value.

"Although we stopped short of meeting our primary endpoint, the disease control rate was 86.1 percent, mDOR was 6.5 months, and progression-free survival was significantly improved to 7.2 months. The safety profile was similar to the side effects observed in other 2nd generation EGFR tyrosine kinase inhibitors (TKI),” the official said.

Spectrum also confirmed the significantly improved safety of poziotinib in Cohort 5, an extended study of NSCLC patients with EGFR or HER2 Exon20 mutation, regardless of past treatment. Each patient received 8 mg per dose twice a day. The changed dosage of twice a day significantly improved the safety of poziotinib, and the company for no new types of adverse reactions.

"The preliminary data from Cohort 5 with 8 mg twice daily dosing supports our hypothesis that the new dosing paradigm improves tolerability substantially, with Grade-3 adverse events reduced by about a third," Spectrum CMO Francois Lebel said. "We believe that improved tolerability and reduced drug dosing interruptions are key to patients staying on the drug longer and could potentially enhance anti-tumor effectiveness across the various EGFR and HER2 cohorts."

He added that the early findings, if confirmed, could benefit the entire poziotinib program.

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