Spectrum announces preliminary poziotinib data from Phase 2 study

Spectrum Pharmaceuticals announced preliminary poziotinib data from the University of Texas, MD Anderson Cancer Center Phase 2 non-small cell lung cancer study which were released during an oral presentation at the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. The MD Anderson study is the single largest data set of patients with an exon 20 mutation in EGFR or HER2. In the interim analysis presented at the WCLC, the following observations were made: This phase II study demonstrates high anti-tumor activity for poziotinib in metastatic, heavily pretreated EGFR exon 20 mutant NSCLC, a group for which no targeted agents have proven effective to date with best response of PR in 55% of evaluable patients. Median PFS 5.5m; durable responses observed with 6 treated for greater than1year thus far. Compares favorably to historical ORR rates of less than8% approved TKIs and less than19% for standard of care 2L agents. Significant activity also observed in HER2 exon 20-mutant NSCLC with initial responses observed in 50% evaluable patients and median PFS 5.1m. EGFR-related toxicities were manageable and required dose reductions in 60%. Discontinuation due to poor tolerance was rare. Encouraging activity has prompted a confirmatory, international, multicenter study in EGFR and HER2 exon 20 mutant NSCLC patients which is currently enrolling, including a first-line cohort, and development of a separate pan-tumor basket study. The poziotinib NSCLC clinical program for patients with EGFR or HER2 exon 20 insertion mutations currently consists of a Phase 2 investigator-initiated study at The University of Texas, MD Anderson Cancer Center and a Phase 2 pivotal, Spectrum-sponsored, multi-center, global study with active sites in the United States and future centers planned in Canada and Europe. The overall poziotinib clinical development program is focused on four pillars, including previously treated NSCLC, first-line treatment of NSCLC, combination therapy and treatment of other solid tumors.

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