Last week, Spectrum Pharmaceuticals, Inc. (NASDAQ:$SSPI), announced the initiation of a Phase 2 trial of poziotinib in non-small cell lung cancer patients with Exon 20 insertion mutation in EGFR or HER2. The biotechnology company runs a fully integrated commercial and drug development operations.
Poziotinib, the drug which they will be testing, is an 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 significantly, 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 various cancers, including, non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer.
With the first patient already enrolled, the Company expects to have up to 87 patients with EGFR exon 20 insertion mutations and up to 87 patients with HER2 exon 20 insertion mutations. The patients will be evaluated throughout the United State in several of the leading cancer institutions.
Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals, said, “following the promising preliminary data from the University of Texas MD Anderson Cancer Center’s study, we are excited to launch this multicenter trial. 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 main focus of the Phase 2 trial would be 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 EGFC or HER2. The trial will evaluate the objective response rate (ORR) as the primary endpoint, and disease control rate (DCR), duration of response (DOR), and safety as secondary endpoints. Lastly, progression-free survival (PFS) and quality of life (QoL) will also be evaluated.
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