On October 30, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported the initiation of a Phase 2 trial evaluating poziotinib in non-small cell lung cancer patients with an exon 20 insertion mutation in EGFR or HER2 (Press release, Spectrum Pharmaceuticals, OCT 30, 2017, View Source [SID1234521305]). The first patient has been enrolled and the Company expects to enroll patients at several leading cancer institutions in the United States.
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“Following the promising preliminary data from the University of Texas MD Anderson Cancer Center’s study, we are excited to launch this multicenter trial,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “Earlier this month, results presented at the 18th IASLC World Conference on Lung Cancer showed that poziotinib has the potential to address unmet needs of lung cancer patients with EGFR Exon 20 insertion mutations. The efficacy of first-generation tyrosine-kinase inhibitors has been found to be unsatisfactory in such patients, resulting in single digit response rates and a progression-free survival of around two months. We are grateful for the guidance the Food and Drug Administration has provided in designing this trial.”
The goal of this Phase 2 trial is to evaluate both the efficacy and safety of poziotinib in patients with non-small cell lung cancer (NSCLC) that is locally advanced or metastatic and have an exon 20 insertion mutation in either EGFR or HER2. This trial will enroll up to 87 patients with EGFR exon 20 insertion mutations and up to 87 patients with HER2 exon 20 insertion mutations in several leading cancer institutions. The study will evaluate objective response rate (ORR) as the primary endpoint, and disease control rate (DCR), duration of response (DOR), and safety as secondary endpoints. In addition, progression-free survival (PFS) and quality of life (QoL) will be evaluated.
Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations; this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer.