Turnaround For Spectrum’s Poziotinib As Phase II Cohort 2 Meets Endpoint
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.
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Encouraging new data for Spectrum/Hanmi’s poziotinib presented at ESMO may increase the chances of approval for the pan-HER inhibitor as a possible first-line therapy for NSCLC with the HER2 exon 20 insertion mutation, although the patient population is limited.
The US firm has two assets but the future looks less than rosy for one of them, the lung cancer therapy poziotinib, after the drug failed a Phase II study.
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