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

Spectrum Pharmaceuticals (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

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