Spectrum Pharmaceuticals (NASDAQ:SPPI) announces positive results from cohort 2 in a Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations.
The 90-subject second cohort met the primary endpoint demonstrating a statistically significant proportion of treated patients who responded (27.8%). Mean duration of response was 5.1 months. The disease control rate (responders + stable cancer) was 70%.
The positive outcome was a reversal of fortune for the epidermal growth factor receptor kinase inhibitor. Cohort 1 failed to achieve the primary endpoint.
The company plans to review the data with the FDA. Additional results from cohort 2 will be presented at an upcoming medical conference. Cohort 2 was designed to be a registrational study.
Management hosts a conference call today at 4:30 pm ET.
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