Hanmi Pharm's 'Poziotinib' Reconfirms Efficacy in First Cancer Treatment Patients

[Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] Hanmi Pharmaceutical's anticancer drug 'Poziotinib' reaffirmed its efficacy by meeting the primary endpoint in a cohort clinical trial targeting cancer patients without prior anticancer treatment history.

Hanmi Pharmaceutical announced on the 8th that Spectrum, the partner company to which Poziotinib was licensed out, disclosed the clinical results including safety and efficacy of the Poziotinib 'Cohort 4' study through an oral presentation at the Targeted Anticancer Therapy (TAT) conference hosted by the European Society for Medical Oncology (ESMO) on the 7th (local time).

This clinical trial is a 'Cohort 4' study within the ZENITH20 trial of Poziotinib, targeting 'treatment-naive HER2 Exon20 mutant non-small cell lung cancer (NSCLC) patients.' Poziotinib was orally administered at 16 mg once daily (48 patients) and 8 mg twice daily (22 patients), followed by analysis of efficacy and safety.

According to the independent review committee's analysis based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the objective response rate (ORR) was 41% in the overall patient group and 50% in the evaluable patient group. The lower bound of the ORR in the overall patient group was 30%, exceeding the pre-defined ORR threshold of 20%, thus meeting the primary endpoint. The safety profile was comparable to other second-generation tyrosine kinase inhibitors (TKIs).

Francois Levele, Chief Medical Officer of Spectrum, stated, “This trial showed positive results in HER2 Exon20 mutant NSCLC patients who currently have no approved treatments,” adding, “Based on these encouraging results, we hope to advance subsequent discussions with the U.S. Food and Drug Administration (FDA) regarding Poziotinib’s approval.”

The FDA is currently conducting an official review of Spectrum’s New Drug Application (NDA) for Poziotinib. This NDA is based on the results of 'Cohort 2' in the ZENITH20 trial, which targeted previously treated HER2 Exon20 mutant NSCLC patients. The FDA is expected to make a final approval decision around November.

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