Spectrum Pharma drops after less-than-favorable Phase 2 data

 

• Spectrum Pharmaceuticals (NASDAQ:SPPI) falls -5.7% in the post-market after the company said the Cohort 3 failed to meet the primary endpoint in a pivotal Phase 2 trial for poziotinib in non-small cell lung cancer.
• However, the FDA has agreed to an NDA based on data from Cohort 2 of the trial, which evaluated previously treated patients with NSCLC HER2 exon 20 insertion mutations.
• Cohort 3 involved 79 first-line NSCLC patients with EGFR exon 20 insertion mutations who received an oral once-daily dose of 16 mg of poziotinib. Based on the pre-specified statistical hypothesis for the primary endpoint, the observed lower bound of 18.4% did not meet the pre-specified lower bound of >20%, despite a similar safety profile to other second-generation EGFR tyrosine kinase inhibitors.
• In the intent-to-treat analysis, Cohort 2, with 90 patients who received an oral once-daily dose of 16 mg of poziotinib, demonstrated a confirmed objective response rate of 27.8% (95% Confidence Interval, 18.9%-38.2%). The observed lower bound of 18.9% exceeded the pre-specified lower bound of 17%.
• However, 87% of patients had drug interruptions, with 11 patients (12%) permanently discontinuing due to adverse events, while 13 patients (14%) had treatment-related serious adverse events.
• Francois Lebel, M.D., the Chief Medical Officer of Spectrum Pharmaceuticals, said “the preliminary data from Cohort 5 with 8 mg twice daily dosing is supporting our hypothesis that this new dosing paradigm improves tolerability substantially, with Grade 3 adverse events reduced by about a third."
• Comprising seven independent cohorts, the ZENITH20 trial evaluates poziotinib in NSCLC patients in a global study across the U.S., Canada, and Europe.
• A webcast and conference call in progress.
• In September, the company announced the Cohort 2 of the trial met its primary endpoint.
• https://seekingalpha.com/news/3646842-spectrum-pharma-drops-after-announcing-less-favorable-phase-2-data