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Turnaround For Spectrum’s Poziotinib As Phase II Cohort 2 Meets Endpoint

 
• By Jung Won Shin

Spectrum is set to discuss NDA submission plans with the US FDA after unveiling positive top line results from Cohort 2 of the Phase II ZENITH20 study with poziotinib, in pretreated NSCLC patients with HER2 exon 20 insertion mutations. The drug, licensed from Hanmi, failed in the Cohort 1 part of the trial earlier this year.

Digital illustration of Cancer cell in colour background
Spectrum To Discuss Poziotinib With FDA To Determine Path Forward • Source: Shutterstock

Spectrum Pharmaceuticals Inc. has said its ZENITH20 Phase II trial evaluating the oral epidermal growth factor receptor tyrosine kinase inhibitor poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2) has met its pre-specified primary endpoint, a turnaround after the failure of Cohort 1 announced earlier this year.

“We are pleased with the results of Cohort 2,” said Francois Lebel, Spectrum's chief medical officer. “There are currently no...

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