Partner Company Spectrum "Applies for New Drug Approval Meeting with US FDA"
[Asia Economy Reporter Seo So-jung] The global Phase 2 cohort 2 study results of Hanmi Pharmaceutical's anticancer drug 'Poziotinib' have confirmed its therapeutic effect.
Hanmi Pharmaceutical announced on the 21st that it presented the global Phase 2 cohort 2 study results of 'Poziotinib' and clinical study results on emergency patients with no treatment alternatives at the European Society for Medical Oncology (ESMO) on the 19th. This year's ESMO was held online due to the impact of the novel coronavirus disease (COVID-19).
Hanmi Pharmaceutical's partner, Spectrum, has initiated procedures for the rapid approval of 'Poziotinib,' including completing a meeting request with the U.S. Food and Drug Administration (FDA) for New Drug Application (NDA) based on the cohort 2 study results.
The cohort 2 study was conducted on 90 patients with EGFR/HER2 exon 20 insertion mutation non-small cell lung cancer who had prior treatment history, administering 16 mg of Poziotinib orally once daily.
As a result, the objective response rate (ORR), an efficacy evaluation index, was 27.8%. The minimum expected ORR for patients with prior treatment was 17%, but the actual minimum ORR was 18.9%, confirming significant results. The disease control rate (DCR) was 70%, and tumor reduction was confirmed in 67 patients, accounting for 74% of the total. The median tumor reduction was 22%. Among 74 evaluable patients, ORR was 35.1% and DCR was 82.4%.
The median duration of response (mDOR) was 5.1 months, the follow-up period was 8.3 months, and the median progression-free survival (mPFS) was 5.5 months.
Severe treatment-related adverse events occurred in 14% (13 patients) of all patients, and 12% (11 patients) discontinued treatment due to adverse events.
Spectrum's Chief Medical Officer, Fran?ois Levele, said, "This presentation at ESMO was the first time the global Phase 2 cohort 2 study results of Poziotinib were disclosed to medical professionals worldwide," adding, "Since there are currently no approved treatments for HER2 exon 20 insertion mutation non-small cell lung cancer, we will discuss various options for approval with the FDA based on these study results."
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