On September 10, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported data from a poster presentation titled: High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Cell Lung Cancer (NSCLC) (Press release, Spectrum Pharmaceuticals, SEP 10, 2022, View Source [SID1234619359]). The data show that poziotinib is highly active in G778 mutations in both treatment naïve and previously treated patients with NSCLC.
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The poster titled "High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Cell Lung Cancer (NSCLC)" is being presented by Xiuning Le, M.D., Ph.D., Assistant Professor, The University of Texas MD Anderson Cancer Center on September 12, 2022. A poster with the data is available to registered participants at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) 2022 taking place in Paris from September 9-13, 2022.
"The G778 mutation is one of the frequent HER2 exon 20 insertion mutations and patients with these tumors have a poor prognosis," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "These findings demonstrate the high activity of poziotinib in both treatment naïve and heavily pre-treated patients."
Results for Poziotinib in this Patient Group
The findings are based on an assessment of the activity of poziotinib in patients with the G778_P780dup HER2 exon 20 insertion mutation in a population of previously treated (Cohort 2) and treatment-naïve (Cohort 4) patients with NSCLC from the ZENITH20 clinical trial. Patients (n=90) in Cohort 2 (C2) received 16 mg of poziotinib once a day (QD) and patients (n=80) in Cohort 4 (C4) received 16 mg QD or 8 mg twice a day (BID). The primary endpoint was objective response rate (ORR). Fourteen patients had the HER2 G778 insertion (C2, n=7; C4, n=7) mutation.
12 of 14 patients were evaluable and all had partial response, resulting in an ORR of 85.7% (95% CI, 57.2, 98.2) and a median DOR of 5.5 months (range 2.9-14.1). The ORR was 100% in the previously treated C2 patients, and 71.4% in the treatment naïve C4 patients. Median DOR was 5.3 months for the C2 patients and 8.9 months for those in C4. The frequency of adverse events (AEs) was consistent with prior reports and overall AEs were similar to the TKI class.
The poster will be available for viewing by registered participants during the conference via the ESMO (Free ESMO Whitepaper) website beginning on September 10, 2022. It will also be available on the Investor Relations section of the company’s website at View Source
About Poziotinib
Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly 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. HER2 exon 20 insertion mutations are a rare subset accounting for approximately 2-4% in NSCLC. There is no approved therapy specifically for either treatment-naïve or previously treated NSCLC with HER2 exon 20 insertion mutations. The company holds an exclusive license from Hanmi Pharmaceutical to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China.