Spectrum Pharmaceuticals (NASDAQ:SPPI) is further expanding its poziotinib clinical program by adding three new cohorts in ZENITH20 trial, evaluating the impact of poziotinib treatment on non-small cell lung cancer (NSCLC) patients.
Three new cohorts are currently open to patient enrollment. Cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations.
Cohort 6 includes patients with EGFR mutations who progressed while on treatment with osimertinib and developed an additional EGFR mutation.
Cohort 7 includes patients with a variety of less common mutations in EGFR or HER2 exons 18-21 or the extracellular or transmembrane domains.
Cohorts 1- 4 are each independently powered for a pre-specified statistical hypothesis and the primary endpoint is objective response rate.
Topline results from cohort 1 (previously treated NSCLC patients with EGFR exon 20 insertion mutations) are expected in Q4 2019.
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