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Spectrum Pharma (SPPI) Presents Additional Poziotinib Data

September 12, 2022 5:46 AM EDT

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced 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). The data show that poziotinib is highly active in G778 mutations in both treatment naïve and previously treated patients with NSCLC.

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) 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 website beginning on September 10, 2022. It will also be available on the Investor Relations section of the company’s website at https://investor.sppirx.com/index.php/events-and-presentations.



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