Spectrum Pharma Highlights Poziotinib Data In Treatment-Naïve Lung Cancer Setting

Spectrum Pharmaceuticals Inc SPPI announced the presentation of safety and efficacy results from Cohort 4 of the ZENITH20 trial evaluating poziotinib in various non-small cell lung cancer settings.

• The data comes from 70 first-line patients with non-small lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16 mg daily, given as 16 mg once daily (48 patients) or 8 mg twice daily (22 patients) of oral poziotinib. 
• The results showed a confirmed objective response rate (ORR) of 41%.
• The evaluable patient population showed an ORR of 50%. The study met its primary endpoint as the observed lower bound of 30% exceeded the pre-specified lower bound of 20%. 
• The safety profile was consistent with the TKI class. 
• Last month, the FDA accepted for review poziotinib application in patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations.
• The agency has set a Prescription Drug User Fee Act (PDUFA) date of November 24.
• Price Action: SPPI shares are up 0.85% at $0.70 during the premarket session on the last check Monday.