South Korea’s Hanmi Pharm’s investigational cancer drug poziotinib has shown positive results in a Phase 2 trial in the U.S., enabling its U.S. partner Spectrum Pharmaceuticals to request a pre-NDA meeting with the FDA based on the efficacy outcome presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 last weekend.

Poziotinib is an oral epidermal growth factor receptor tyrosine kinase inhibitor that suppresses tumor proliferation. Spectrum received exclusive license from Hanmi Pharm to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China.

The Cohort 2 of the Phase 2 trial enrolled 90 previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations. The patients received an oral once daily dose of 16 mg of poziotinib.

The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8 percent while the disease control rate (DCR) was 70 percent and tumor reduction occurred in 67 patients (74 percent).

The median duration of response (mDOR) was 5.1 months, with a median follow up of 8.3 months and the median progression free survival (mPFS) was 5.5 months.

In addition, 13 patients (14 percent) had treatment-related serious adverse events and 11 patients (12 percent) discontinued due to adverse events.

The Phase 2 trial is comprised of seven independent cohorts. Cohorts 1-4 are each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR. Cohorts 5-7 are exploratory.

By Pulse

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